Pharsight

Patent Litigations

1. Arazlo patents expiration

ARAZLO litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US11311482 June, 2023 Notice of Filing Date Accorded Bausch Health Ireland Limited et al. Padagis Israel Pharmaceuticals Ltd. et al.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11311482 BAUSCH Topical compositions and methods for treating skin diseases
May, 2038

(14 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Dec 18, 2022

Drugs and Companies using TAZAROTENE ingredient

Market Authorisation Date: 18 December, 2019

Treatment: Topical treatment of acne vulgaris in patients 9 years of age and older

Dosage: LOTION;TOPICAL

How can I launch a generic of ARAZLO before it's drug patent expiration?
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ARAZLO family patents

Family Patents

2. Ozempic patents expiration

What is Ozempic?

Ozempic (semaglutide) is an injectable medication used to improve blood sugar levels in adults with type 2 diabetes. It belongs to a class of drugs called GLP-1 receptor agonists and works by mimicking the effects of the hormone GLP-1, which helps regulate blood sugar levels. Ozempic slows digestion and decreases appetite, leading to improved glycemic control and potential weight loss benefits.

What is the Ozempic controversy?

The injectable diabetes medication Ozempic (semaglutide) has recently seen its FDA-approved label updated to warn of potential serious intestinal side effects like obstruction or blockage. The newly added FDA warning highlights that Ozempic may cause severe gastrointestinal issues like intestinal obstruction, intense abdominal pain, vomiting, constipation, and abdominal swelling.

OZEMPIC's oppositions filed in EPO

OZEMPIC litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US10335462 March, 2023 PO preliminary response filed Novo Nordisk A/S Mylan Pharmaceuticals Inc. et al.
US8129343 March, 2023 PO preliminary response filed Novo Nordisk A/S Mylan Pharmaceuticals Inc. et al.
US8536122 March, 2023 PO preliminary response filed Novo Nordisk A/S Mylan Pharmaceuticals Inc. et al.
US8114833 March, 2022 Terminated-Settled Novo Nordisk A/S Fresenius Kabi USA, LLC
US8114833 July, 2020 Terminated-Settled Novo Nordisk A/S Pfizer Inc.
US8114833 December, 2019 Terminated-Settled Novo Nordisk A/S et al. Pfizer Inc. et al.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8536122 NOVO Acylated GLP-1 compounds
Mar, 2026

(1 year, 10 months from now)

US8129343 NOVO Acylated GLP-1 compounds
Dec, 2031

(7 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8114833 NOVO Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Aug, 2025

(1 year, 3 months from now)

US10335462 NOVO Use of long-acting GLP-1 peptides
Jun, 2033

(9 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Dosing Schedule(D-185) Mar 28, 2025
New Chemical Entity Exclusivity(NCE) Dec 05, 2022
New Indication(I-822) Jan 16, 2023

Drugs and Companies using SEMAGLUTIDE ingredient

NCE-1 date: 05 December, 2021

Market Authorisation Date: 05 December, 2017

Treatment: A method of treating type 2 diabetes comprising administering semaglutide once weekly in a amount of 1.0 mg to a subject in need thereof; Ozempic is indicated as an adjunct to diet and exercise to imp...

Dosage: SOLUTION;SUBCUTANEOUS

How can I launch a generic of OZEMPIC before it's drug patent expiration?
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OZEMPIC family patents

Family Patents

3. Rybelsus patents expiration

RYBELSUS's oppositions filed in EPO

RYBELSUS litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8129343 March, 2023 PO preliminary response filed Novo Nordisk A/S Mylan Pharmaceuticals Inc. et al.
US8536122 March, 2023 PO preliminary response filed Novo Nordisk A/S Mylan Pharmaceuticals Inc. et al.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8536122 NOVO Acylated GLP-1 compounds
Mar, 2026

(1 year, 10 months from now)

US8129343 NOVO Acylated GLP-1 compounds
Dec, 2031

(7 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Sep 20, 2022
New Chemical Entity Exclusivity(NCE) Dec 05, 2022
M(M-252) Jan 16, 2023

Drugs and Companies using SEMAGLUTIDE ingredient

NCE-1 date: 05 December, 2021

Market Authorisation Date: 20 September, 2019

Treatment: Method of treating type 2 diabetes mellitus

Dosage: TABLET;ORAL

More Information on Dosage

RYBELSUS family patents

Family Patents

4. Wegovy patents expiration

WEGOVY's oppositions filed in EPO

WEGOVY litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8129343 March, 2023 PO preliminary response filed Novo Nordisk A/S Mylan Pharmaceuticals Inc. et al.
US8536122 March, 2023 PO preliminary response filed Novo Nordisk A/S Mylan Pharmaceuticals Inc. et al.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8536122 NOVO Acylated GLP-1 compounds
Mar, 2026

(1 year, 10 months from now)

US8129343 NOVO Acylated GLP-1 compounds
Dec, 2031

(7 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Jun 04, 2024
New Dosing Schedule(D-190) Jul 21, 2026
New Indication(I-935) Mar 08, 2027
New Patient Population(NPP) Dec 23, 2025
New Chemical Entity Exclusivity(NCE) Dec 05, 2022

Drugs and Companies using SEMAGLUTIDE ingredient

NCE-1 date: 05 December, 2021

Market Authorisation Date: 04 June, 2021

Treatment: NA

Dosage: SOLUTION;SUBCUTANEOUS

How can I launch a generic of WEGOVY before it's drug patent expiration?
More Information on Dosage

WEGOVY family patents

Family Patents

5. Mavenclad patents expiration

MAVENCLAD's oppositions filed in EPO

MAVENCLAD litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US10849919 February, 2023 Terminated-Settled Ares Trading SA Hopewell Pharma Ventures, Inc. et al.
US7713947 January, 2023 PO preliminary response filed Merck Serono SA Hopewell Pharma Ventures, Inc. et al.
US8377903 January, 2023 PO preliminary response filed Merck Serono SA Hopewell Pharma Ventures, Inc. et al.
US7713947 October, 2022 Institution Denied Merck Serono SA TWi Pharmaceuticals, Inc.
US8377903 October, 2022 Institution Denied Merck Serono SA TWi Pharmaceuticals, Inc.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8377903 EMD SERONO INC Cladribine regimen for treating multiple sclerosis
May, 2026

(2 years from now)

US7713947 EMD SERONO INC Cladribine regimen for treating multiple sclerosis
Oct, 2026

(2 years from now)

US10849919 EMD SERONO INC Cladribine regimen for treating progressive forms of multiple sclerosis
Nov, 2038

(14 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Mar 29, 2022

Drugs and Companies using CLADRIBINE ingredient

Market Authorisation Date: 29 March, 2019

Treatment: Treating rrms or spms with oral cladribine: (i) 2-4 months induction with 1.7 mg/kg - 3.5 mg/kg cladribine; (ii) cladribine-free period of about 8-10 months; (iii) 2-4 months maintenance with about 1....

Dosage: TABLET;ORAL

How can I launch a generic of MAVENCLAD before it's drug patent expiration?
More Information on Dosage

MAVENCLAD family patents

Family Patents

6. Onureg patents expiration

ONUREG's oppositions filed in EPO

ONUREG litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8846628 February, 2023 Trial Instituted CELGENE CORPORATION et al. Apotex Inc. et al.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8846628 BRISTOL Oral formulations of cytidine analogs and methods of use thereof
Jun, 2030

(6 years from now)

Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-320) Sep 01, 2027
New Product(NP) Sep 01, 2023

Drugs and Companies using AZACITIDINE ingredient

Market Authorisation Date: 01 September, 2020

Treatment: Continued treatment of adults with acute myeloid leukemia who achieved first complete remission (cr) or cr with incomplete blood count recovery following intensive induction chemotherapy and are not a...

Dosage: TABLET;ORAL

How can I launch a generic of ONUREG before it's drug patent expiration?
More Information on Dosage

ONUREG family patents

Family Patents

7. Calquence patents expiration

CALQUENCE litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US10272083 February, 2023 Institution Denied Acerta Pharma B.V. et al. Sandoz Inc.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10272083 ASTRAZENECA Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Jan, 2035

(10 years from now)

Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-175) Oct 31, 2024
Orphan Drug Exclusivity(ODE-274) Nov 21, 2026
New Indication(I-817) Nov 21, 2022
New Chemical Entity Exclusivity(NCE) Oct 31, 2022

Drugs and Companies using ACALABRUTINIB ingredient

NCE-1 date: 31 October, 2021

Market Authorisation Date: 31 October, 2017

Treatment: Treatment of adult patients with previously untreated small lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily in combination with obinutuzumab

Dosage: CAPSULE;ORAL

How can I launch a generic of CALQUENCE before it's drug patent expiration?
More Information on Dosage

CALQUENCE family patents

Family Patents

8. Calquence patents expiration

CALQUENCE litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US10272083 February, 2023 Institution Denied Acerta Pharma B.V. et al. Sandoz Inc.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10272083 ASTRAZENECA Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Jan, 2035

(10 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Oct 31, 2022

Drugs and Companies using ACALABRUTINIB MALEATE ingredient

NCE-1 date: 31 October, 2021

Market Authorisation Date: 03 August, 2022

Treatment: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab by administering 100 mg of acalabrutinib twice daily

Dosage: TABLET;ORAL

More Information on Dosage

CALQUENCE family patents

Family Patents

9. Venclexta patents expiration

VENCLEXTA litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US11110087 October, 2022 Trial Instituted Genentech, Inc. et al. Dr. Reddy's Laboratories, Inc. et al.
US10993942 February, 2022 Final Written Decision Genentech, Inc. et al. Dr. Reddy's Laboratories, Inc. et al.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10993942 ABBVIE Combination therapy of a type II anti-CD20 antibody with a selective BCL-2 inhibitor
Sep, 2033

(9 years from now)

US11110087 ABBVIE Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor
Sep, 2033

(9 years from now)

Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-185) Jun 08, 2025
Orphan Drug Exclusivity(ODE-211) Nov 21, 2025
Orphan Drug Exclusivity(ODE-239) May 15, 2026
New Chemical Entity Exclusivity(NCE) Apr 11, 2021
Orphan Drug Exclusivity(ODE) Apr 11, 2023
New Indication(I-789) Nov 21, 2021
New Indication(I-795) May 15, 2022
M(M-265) Oct 16, 2023
Orphan Drug Exclusivity(ODE-114) Apr 11, 2023
M(M-228) Jun 08, 2021
New Indication(I-782) Jun 08, 2021

Drugs and Companies using VENETOCLAX ingredient

NCE-1 date: 11 April, 2020

Market Authorisation Date: 11 April, 2016

Treatment: Treatment of chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll) by orally administering venetoclax to an adult according to a dose ramp-up that includes a dose of 50 mg per day for...

Dosage: TABLET;ORAL

How can I launch a generic of VENCLEXTA before it's drug patent expiration?
More Information on Dosage

VENCLEXTA family patents

Family Patents

10. Trulance patents expiration

TRULANCE's oppositions filed in EPO

TRULANCE litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US7041786 October, 2022 Final Written Decision Bausch Health Ireland Limited et al. MSN Laboratories Private Ltd. et al.
US9610321 June, 2022 Institution Denied Bausch Health Ireland Limited et al. Mylan Pharmaceuticals Inc. et al.
US9616097 June, 2022 Institution Denied Bausch Health Ireland Limited et al. Mylan Pharmaceuticals Inc. et al.
US9919024 June, 2022 Institution Denied Bausch Health Ireland Limited et al. Mylan Pharmaceuticals Inc. et al.
US9925231 June, 2022 Institution Denied Bausch Health Ireland Limited et al. Mylan Pharmaceuticals Inc. et al.
US7041786 March, 2022 Final Written Decision Bausch Health Ireland Limited et al. Mylan Pharmaceuticals Inc. et al.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7041786 SALIX Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis
Jan, 2028

(3 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9925231 SALIX Formulations of guanylate cyclase C agonists and methods of use
Sep, 2031

(7 years from now)

US9610321 SALIX Formulations of guanylate cyclase C agonists and methods of use
Sep, 2031

(7 years from now)

US9919024 SALIX Formulations of guanylate cyclase C agonists and methods of use
Sep, 2031

(7 years from now)

US9616097 SALIX Formulations of guanylate cyclase C agonists and methods of use
Aug, 2032

(8 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jan 19, 2022
New Indication(I-764) Jan 24, 2021

Drugs and Companies using PLECANATIDE ingredient

NCE-1 date: 19 January, 2021

Market Authorisation Date: 19 January, 2017

Treatment: Irritable bowel syndrome with constipation; Chronic idiopathic constipation

Dosage: TABLET;ORAL

How can I launch a generic of TRULANCE before it's drug patent expiration?
More Information on Dosage

TRULANCE family patents

Family Patents

11. Xarelto patents expiration

XARELTO's oppositions filed in EPO

XARELTO litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US10828310 September, 2022 Final Written Decision Bayer Pharma AG et al. Teva Pharmaceuticals USA, Inc
US10828310 September, 2022 Final Written Decision Bayer Pharma AG et al. InvaGen Pharmaceuticals, Inc. et al.
US10828310 February, 2022 Final Written Decision Bayer Pharma AG et al. Mylan Pharmaceuticals Inc. et al.
US9539218 May, 2018 Terminated-Denied Bayer Intellectual Property GmbH Mylan Pharmaceuticals Inc.
US7157456 October, 2016 Terminated-Dismissed Bayer Intellectual Property GmbH Mylan Pharmaceuticals Inc
US9539218 January, 2014 Decision Frank Misselwitz et al
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7157456 JANSSEN PHARMS Substituted oxazolidinones and their use in the field of blood coagulation
Aug, 2024

(4 months from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9539218 JANSSEN PHARMS Prevention and treatment of thromboembolic disorders
Feb, 2034

(9 years from now)

US10828310 JANSSEN PHARMS Reducing the risk of cardiovascular events
Jan, 2039

(14 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-867) Aug 23, 2024
Pediatric Exclusivity(PED) Feb 23, 2025
New Indication(I-824) Oct 11, 2021
New Dosing Schedule(D-168) Oct 27, 2020
New Indication(I-810) Oct 11, 2022
M(M-284) Mar 10, 2023
New Indication(I-660) Nov 02, 2015
New Indication(I-661) Nov 02, 2015
New Indication(I-662) Nov 02, 2015
New Chemical Entity Exclusivity(NCE) Jul 01, 2016
New Indication(I-643) Nov 04, 2014

Drugs and Companies using RIVAROXABAN ingredient

NCE-1 date: 24 February, 2024

Market Authorisation Date: 11 October, 2018

Treatment: Treatment of dvt and/or pe and reduction in risk of recurrent dvt and/or pe in pediatric patients (30-49.9 kg) once daily with rapid-release tablet administered for at least 5 consecutive days after a...

Dosage: TABLET;ORAL; FOR SUSPENSION;ORAL

How can I launch a generic of XARELTO before it's drug patent expiration?
More Information on Dosage

XARELTO family patents

Family Patents

12. Idhifa patents expiration

IDHIFA litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US10610125 August, 2022 Terminated-Settled Servier Pharmaceuticals LLC et al. Rigel Pharmaceuticals, Inc.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10610125 BRISTOL MYERS SQUIBB Methods and compositions for cell-proliferation-related disorders
Jun, 2030

(6 years from now)

Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-151) Aug 01, 2024
Orphan Drug Exclusivity(ODE) Aug 01, 2024
New Chemical Entity Exclusivity(NCE) Aug 01, 2022

Drugs and Companies using ENASIDENIB MESYLATE ingredient

NCE-1 date: 01 August, 2021

Market Authorisation Date: 01 August, 2017

Treatment: Treatment of relapsed or refractory acute myeloid leukemia (aml) with an isocitrate dehydrogenase-2 (idh2) mutation

Dosage: TABLET;ORAL

More Information on Dosage

IDHIFA family patents

Family Patents

13. Tibsovo patents expiration

TIBSOVO litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US10610125 August, 2022 Terminated-Settled Servier Pharmaceuticals LLC et al. Rigel Pharmaceuticals, Inc.
Can you believe TIBSOVO received compensation for the extended wait time during the regulatory approval process?
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10610125 SERVIER Methods and compositions for cell-proliferation-related disorders
Jun, 2030

(6 years from now)

Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-203) Jul 20, 2025
Orphan Drug Exclusivity(ODE-242) May 02, 2026
New Indication(I-875) Aug 25, 2024
New Indication(I-924) Oct 24, 2026
Orphan Drug Exclusivity(ODE-368) Aug 25, 2028
Orphan Drug Exclusivity(ODE-447) Oct 24, 2030
New Indication(I-893) May 25, 2025
New Chemical Entity Exclusivity(NCE) Jul 20, 2023
New Indication(I-816) May 02, 2022

Drugs and Companies using IVOSIDENIB ingredient

NCE-1 date: 20 July, 2022

Market Authorisation Date: 20 July, 2018

Treatment: A method for treating newly diagnosed aml with ivosidenib and azacitidine wherein the aml has an idh1 mutation capable of converting alpha-ketoglutarate to 2-hydroxyglutarate (2hg)

Dosage: TABLET;ORAL

How can I launch a generic of TIBSOVO before it's drug patent expiration?
More Information on Dosage

TIBSOVO family patents

Family Patents

14. Saxenda patents expiration

SAXENDA's oppositions filed in EPO

SAXENDA litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8114833 March, 2022 Terminated-Settled Novo Nordisk A/S Fresenius Kabi USA, LLC
US8114833 July, 2020 Terminated-Settled Novo Nordisk A/S Pfizer Inc.
US8114833 December, 2019 Terminated-Settled Novo Nordisk A/S et al. Pfizer Inc. et al.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8114833 NOVO Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Aug, 2025

(1 year, 3 months from now)

Drug Exclusivity Drug Exclusivity Expiration
New Patient Population(NPP) Dec 04, 2023
New Chemical Entity Exclusivity(NCE) Jan 25, 2015
New Product(NP) Jan 25, 2017

Drugs and Companies using LIRAGLUTIDE RECOMBINANT ingredient

NCE-1 date: 25 January, 2014

Market Authorisation Date: 23 December, 2014

Treatment: NA

Dosage: SOLUTION;SUBCUTANEOUS

More Information on Dosage

SAXENDA family patents

Family Patents

15. Victoza patents expiration

VICTOZA's oppositions filed in EPO

VICTOZA litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8114833 March, 2022 Terminated-Settled Novo Nordisk A/S Fresenius Kabi USA, LLC
US8114833 July, 2020 Terminated-Settled Novo Nordisk A/S Pfizer Inc.
US8114833 December, 2019 Terminated-Settled Novo Nordisk A/S et al. Pfizer Inc. et al.
US9265893 January, 2014 Decision Torben Stroem Hansen et al
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8114833 NOVO NORDISK INC Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Aug, 2025

(1 year, 3 months from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9265893 NOVO NORDISK INC Injection button
Sep, 2032

(8 years from now)

Drug Exclusivity Drug Exclusivity Expiration
M(M-176) Apr 22, 2019
New Patient Population(NPP) Jun 17, 2022
New Indication(I-750) Aug 25, 2020
Pediatric Exclusivity(PED) Dec 17, 2022
M(M-115) Apr 06, 2015
New Chemical Entity Exclusivity(NCE) Jan 25, 2015

Drugs and Companies using LIRAGLUTIDE RECOMBINANT ingredient

NCE-1 date: 17 December, 2021

Market Authorisation Date: 25 January, 2010

Treatment: NA

Dosage: SOLUTION;SUBCUTANEOUS

More Information on Dosage

VICTOZA family patents

Family Patents

16. Lupkynis patents expiration

LUPKYNIS litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US10286036 February, 2022 Terminated-Settled Aurinia Pharmaceuticals Inc. Sun Pharmaceutical Industries Ltd. et al.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10286036 AURINIA Protocol for treatment of lupus nephritis
Dec, 2037

(13 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jan 22, 2026

Drugs and Companies using VOCLOSPORIN ingredient

NCE-1 date: 22 January, 2025

Market Authorisation Date: 22 January, 2021

Treatment: Treatment of patients with active lupus nephritis

Dosage: CAPSULE;ORAL

More Information on Dosage

LUPKYNIS family patents

Family Patents

17. Vascepa patents expiration

VASCEPA's oppositions filed in EPO

VASCEPA litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8642077 November, 2021 Terminated-Settled Amarin Pharmaceuticals Ireland Limited Hikma Pharmaceuticals USA Inc. et al.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8642077 AMARIN PHARMS Stable pharmaceutical composition and methods of using same
Apr, 2030

(6 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jul 26, 2017
New Indication(I-819) Dec 13, 2022
New Product(NP) Jul 26, 2015

Drugs and Companies using ICOSAPENT ETHYL ingredient

NCE-1 date: 26 July, 2016

Market Authorisation Date: 26 July, 2012

Treatment: Use of vascepa to reduce triglycerides in a mixed dyslipidemia adult patient with elevated triglyceride (tg) levels (>= 150 mg/dl) and on statin therapy

Dosage: CAPSULE;ORAL

How can I launch a generic of VASCEPA before it's drug patent expiration?
More Information on Dosage

VASCEPA family patents

Family Patents

18. Lumify patents expiration

LUMIFY litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8293742 November, 2021 Final Written Decision - Appealed Eye Therapies, LLC et al. Slayback Pharma LLC et al.
US9259425 November, 2021 Terminated-Settled Eye Therapies, LLC Slayback Pharma LLC
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9259425 BAUSCH AND LOMB INC Compositions and methods for eye whitening
Jul, 2030

(6 years from now)

US8293742 BAUSCH AND LOMB INC Preferential vasoconstriction compositions and methods of use
Jul, 2030

(6 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Dec 22, 2020

Drugs and Companies using BRIMONIDINE TARTRATE ingredient

Market Authorisation Date: 22 December, 2017

Treatment: Relieves redness of the eye due to minor eye irritations

Dosage: SOLUTION/DROPS;OPHTHALMIC

How can I launch a generic of LUMIFY before it's drug patent expiration?
More Information on Dosage

LUMIFY family patents

Family Patents

19. Pedmark patents expiration

PEDMARK litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US10596190 October, 2021 Final Written Decision Oregon Health & Science University et al. Hope Medical Enterprises, Inc.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10596190 FENNEC PHARMS INC Method for reducing ototoxicity in pediatric patients receiving platinum-based chemotherapy
Jan, 2038

(13 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Sep 20, 2025
Orphan Drug Exclusivity(ODE-384) Sep 20, 2029

Drugs and Companies using SODIUM THIOSULFATE ingredient

Market Authorisation Date: 20 September, 2022

Treatment: A method of reducing ototoxicity in a human pediatric patient about 5 years of age or under with localized medulloblastoma comprising administering sodium thiosulfate about six hours after administrat...

Dosage: SOLUTION;INTRAVENOUS

How can I launch a generic of PEDMARK before it's drug patent expiration?
More Information on Dosage

PEDMARK family patents

Family Patents

20. Thiola Ec patents expiration

THIOLA EC litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US11458104 October, 2021 Decision Mission Pharmacal Company
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11458104 MISSION PHARMACAL Enteric coated tiopronin tablet
Nov, 2038

(14 years from now)

Drug Exclusivity Drug Exclusivity Expiration
ODE*(ODE*) Jun 28, 2026

Drugs and Companies using TIOPRONIN ingredient

Market Authorisation Date: 28 June, 2019

Treatment: A method of treating cystinuria by orally administering tiopronin with food to prevent cystine stone formation in adults and pediatric patients with severe homozygous cystinuria

Dosage: TABLET, DELAYED RELEASE;ORAL

How can I launch a generic of THIOLA EC before it's drug patent expiration?
More Information on Dosage

THIOLA EC family patents

Family Patents

21. Levulan patents expiration

LEVULAN litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US10357567 October, 2021 Terminated-Dismissed DUSA Pharmaceuticals, Inc. et al. Biofrontera Inc. et al.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10357567 DUSA Methods for photodynamic therapy
Jan, 2038

(13 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-766) Mar 09, 2021
M(M-82) Mar 12, 2013

Drugs and Companies using AMINOLEVULINIC ACID HYDROCHLORIDE ingredient

Market Authorisation Date: 03 December, 1999

Treatment: Treatment of actinic keratoses of upper extremities by photodynamic therapy

Dosage: SOLUTION;TOPICAL

More Information on Dosage

LEVULAN family patents

Family Patents

22. Austedo patents expiration

AUSTEDO litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8524733 September, 2021 Terminated-Denied Auspex Pharmaceuticals, Inc. Apotex Inc.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8524733 TEVA BRANDED PHARM Benzoquinoline inhibitors of vesicular monoamine transporter 2
Apr, 2031

(6 years from now)

Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-134) Apr 03, 2024
M(M-54) Jun 24, 2024
Pediatric Exclusivity(PED) Dec 24, 2024
New Indication(I-751) Aug 30, 2020
New Chemical Entity Exclusivity(NCE) Apr 03, 2022
Orphan Drug Exclusivity(ODE) Apr 03, 2024

Drugs and Companies using DEUTETRABENAZINE ingredient

NCE-1 date: 25 December, 2023

Market Authorisation Date: 03 April, 2017

Treatment: NA

Dosage: TABLET;ORAL

How can I launch a generic of AUSTEDO before it's drug patent expiration?
More Information on Dosage

AUSTEDO family patents

Family Patents

23. Austedo Xr patents expiration

AUSTEDO XR litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8524733 September, 2021 Terminated-Denied Auspex Pharmaceuticals, Inc. Apotex Inc.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8524733 TEVA Benzoquinoline inhibitors of vesicular monoamine transporter 2
Apr, 2031

(6 years from now)

Drugs and Companies using DEUTETRABENAZINE ingredient

Market Authorisation Date: 17 February, 2023

Treatment: NA

Dosage: TABLET, EXTENDED RELEASE;ORAL

More Information on Dosage

AUSTEDO XR family patents

Family Patents

24. Chantix patents expiration

CHANTIX litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US6890927 June, 2021 Terminated-Settled Pfizer Inc. Apotex Inc. et al.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6890927 PF PRISM CV Tartrate salts of 5,8, 14-triazateracyclo[10.3.1.02,11 04.9]-hexadeca-2(11),3,5,7,9-pentaene and pharmaceutical compositions thereof
May, 2022

(1 year, 11 months ago)

Drug Exclusivity Drug Exclusivity Expiration
M(M-192) Dec 16, 2019
Pediatric Exclusivity(PED) Aug 22, 2022
M(M-183) Aug 12, 2019
M(M-144) Oct 15, 2017
M(M-143) Oct 15, 2017
M(M-237) Feb 22, 2022
M(M-105) Jul 22, 2014

Drugs and Companies using VARENICLINE TARTRATE ingredient

Market Authorisation Date: 10 May, 2006

Treatment: Aid to smoking cessation

Dosage: TABLET;ORAL

How can I launch a generic of CHANTIX before it's drug patent expiration?
More Information on Dosage

CHANTIX family patents

Family Patents

25. Qelbree patents expiration

QELBREE litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US11324753 February, 2021 Decision Supernus Pharmaceuticals, Inc.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11324753 SUPERNUS PHARMS Method of treatment of attention deficit/hyperactivity disorder (ADHD)
Sep, 2029

(5 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Apr 02, 2026
New Patient Population(NPP) Apr 29, 2025

Drugs and Companies using VILOXAZINE HYDROCHLORIDE ingredient

NCE-1 date: 02 April, 2025

Market Authorisation Date: 02 April, 2021

Treatment: For the treatment of attention deficit hyperactivity disorder (adhd)

Dosage: CAPSULE, EXTENDED RELEASE;ORAL

More Information on Dosage

QELBREE family patents

Family Patents

26. Tyvaso patents expiration

TYVASO litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US10716793 January, 2021 Final Written Decision - Appealed United Therapeutics Corporation Liquidia Technologies, Inc.
US9593066 March, 2020 Terminated-Denied United Therapeutics Corp. Liquidia Technologies, Inc.
US9604901 March, 2020 FWD Entered United Therapeutics Corp. Liquidia Technolgies, Inc.
US9339507 June, 2017 Terminated-Settled United Therapeutics Corp. Watson Laboratories, Inc.
US9358240 June, 2017 Terminated-Settled United Therapeutics Corp. Watson Laboratories, Inc.
US8497393 October, 2015 FWD Entered United Therapeutics Corporation SteadyMed Ltd.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8497393 UNITED THERAP Process to prepare treprostinil, the active ingredient in Remodulin®
Dec, 2028

(4 years from now)

US9593066 UNITED THERAP Process to prepare treprostinil, the active ingredient in remodulin®
Dec, 2028

(4 years from now)

US9604901 UNITED THERAP Process to prepare treprostinil, the active ingredient in Remodulin®
Dec, 2028

(4 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10716793 UNITED THERAP Treprostinil administration by inhalation
May, 2027

(3 years from now)

US9339507 UNITED THERAP Treprostinil administration by inhalation
Mar, 2028

(3 years from now)

US9358240 UNITED THERAP Treprostinil administration by inhalation
May, 2028

(4 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-856) Mar 31, 2024
M(M-145) May 20, 2017
Orphan Drug Exclusivity(ODE) Jul 30, 2016
New Dosage Form(NDF) Jul 30, 2012

Drugs and Companies using TREPROSTINIL ingredient

Market Authorisation Date: 30 July, 2009

Treatment: Method of treating pulmonary hypertension by administering treprostinil or a salt thereof by inhalation using a device

Dosage: SOLUTION;INHALATION

How can I launch a generic of TYVASO before it's drug patent expiration?
More Information on Dosage

TYVASO family patents

Family Patents

27. Tyvaso Dpi patents expiration

TYVASO DPI litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US10716793 January, 2021 Final Written Decision - Appealed United Therapeutics Corporation Liquidia Technologies, Inc.
US9593066 March, 2020 Terminated-Denied United Therapeutics Corp. Liquidia Technologies, Inc.
US9604901 March, 2020 FWD Entered United Therapeutics Corp. Liquidia Technolgies, Inc.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9593066 UNITED THERAP Process to prepare treprostinil, the active ingredient in remodulin®
Dec, 2028

(4 years from now)

US9604901 UNITED THERAP Process to prepare treprostinil, the active ingredient in Remodulin®
Dec, 2028

(4 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10716793 UNITED THERAP Treprostinil administration by inhalation
May, 2027

(3 years from now)

Drugs and Companies using TREPROSTINIL ingredient

Market Authorisation Date: 23 May, 2022

Treatment: Method of treating pulmonary hypertension by administering treprostinil or a salt thereof by inhalation using a device

Dosage: POWDER;INHALATION

More Information on Dosage

TYVASO DPI family patents

Family Patents

28. Cerdelga patents expiration

CERDELGA's oppositions filed in EPO

CERDELGA litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US11458119 November, 2020 Decision Hanlan Liu et al.
US10888547 April, 2019 Decision Genzyme Corporation
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US11458119 GENZYME CORP Amorphous and a crystalline form of genz 112638 hemitartrate as inhibitor of glucosylceramide synthase
Nov, 2030

(6 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10888547 GENZYME CORP Amorphous and a crystalline form of genz 112638 hemitartrate as inhibitor of glucosylceramide synthase
Jan, 2031

(6 years from now)

Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE) Aug 19, 2021
New Chemical Entity Exclusivity(NCE) Aug 19, 2019
Orphan Drug Exclusivity(ODE-73) Aug 19, 2021

Drugs and Companies using ELIGLUSTAT TARTRATE ingredient

NCE-1 date: 19 August, 2018

Market Authorisation Date: 19 August, 2014

Treatment: Long-term treatment of adults with gaucher disease type 1 who are cyp2d6 extensive or intermediate metabolizers with 84 mg twice per day of eliglustat (equivalent to 100 mg of eliglustat tartrate twic...

Dosage: CAPSULE;ORAL

How can I launch a generic of CERDELGA before it's drug patent expiration?
More Information on Dosage

CERDELGA family patents

Family Patents

29. Cabenuva Kit patents expiration

CABENUVA KIT's oppositions filed in EPO

CABENUVA KIT litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US11389447 October, 2020 Decision JANSSEN SCIENCES IRELAND UC
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11389447 VIIV HLTHCARE Aqueous suspensions of TMC278
Jun, 2027

(3 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jan 21, 2026
New Patient Population(NPP) Mar 29, 2025
New Dosing Schedule(D-184) Jan 31, 2025

Drugs and Companies using CABOTEGRAVIR; RILPIVIRINE ingredient

NCE-1 date: 21 January, 2025

Market Authorisation Date: 21 January, 2021

Treatment: Treatment of hiv-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg by monthly administration of rilpivirine suspension as part of combination therapy

Dosage: SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

More Information on Dosage

CABENUVA KIT family patents

Family Patents

30. Lutathera patents expiration

LUTATHERA litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US10596276 October, 2020 Institution Denied Advanced Accelerator Applications SA Evergreen Theragnostics, Inc.
US10596278 October, 2020 Terminated-Denied Advanced Accelerator Applications SA Evergreen Theragnostics, Inc.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10596278 AAA USA INC Stable, concentrated radionuclide complex solutions
Jul, 2038

(14 years from now)

US10596276 AAA USA INC Stable, concentrated radionuclide complex solutions
Jul, 2038

(14 years from now)

Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-166) Jan 26, 2025
New Chemical Entity Exclusivity(NCE) Jan 26, 2023

Drugs and Companies using LUTETIUM LU 177 DOTATATE ingredient

NCE-1 date: 26 January, 2022

Market Authorisation Date: 26 January, 2018

Treatment: NA

Dosage: SOLUTION;INTRAVENOUS

More Information on Dosage

LUTATHERA family patents

Family Patents

31. Elcys patents expiration

ELCYS litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US10653719 September, 2020 Institution Denied Exela Pharma Sciences LLC Eton Pharmaceuticals, Inc.
US10583155 June, 2020 Terminated-Denied Exela Pharma Sciences, LLC Eton Pharmaceuticals Inc.
US10478453 May, 2020 Institution Denied Exela Pharma Sciences, LLC Eton Pharmaceuticals, Inc.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10653719 EXELA PHARMA Stable, highly pure L-cysteine compositions for injection and methods of use
Jan, 2039

(14 years from now)

US10478453 EXELA PHARMA Stable, highly pure L-cysteine compositions for injection and methods of use
Jan, 2039

(14 years from now)

US10583155 EXELA PHARMA Stable, highly pure L-cysteine compositions for injection and methods of use
Jan, 2039

(14 years from now)

Drugs and Companies using CYSTEINE HYDROCHLORIDE ingredient

Market Authorisation Date: 16 April, 2019

Treatment: Method of using l-cysteine in an admixture for treating patients needing parenteral nutrition

Dosage: SOLUTION;INTRAVENOUS

How can I launch a generic of ELCYS before it's drug patent expiration?
More Information on Dosage

ELCYS family patents

Family Patents

32. Nouress patents expiration

NOURESS litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US10653719 September, 2020 Institution Denied Exela Pharma Sciences LLC Eton Pharmaceuticals, Inc.
US10583155 June, 2020 Terminated-Denied Exela Pharma Sciences, LLC Eton Pharmaceuticals Inc.
US10478453 May, 2020 Institution Denied Exela Pharma Sciences, LLC Eton Pharmaceuticals, Inc.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10478453 BAXTER HLTHCARE CORP Stable, highly pure L-cysteine compositions for injection and methods of use
Jan, 2039

(14 years from now)

US10583155 BAXTER HLTHCARE CORP Stable, highly pure L-cysteine compositions for injection and methods of use
Jan, 2039

(14 years from now)

US10653719 BAXTER HLTHCARE CORP Stable, highly pure L-cysteine compositions for injection and methods of use
Jan, 2039

(14 years from now)

Drugs and Companies using CYSTEINE HYDROCHLORIDE ingredient

Market Authorisation Date: 13 December, 2019

Treatment: Method of using l-cysteine in an admixture for treating patients needing parenteral nutrition

Dosage: SOLUTION;INTRAVENOUS

More Information on Dosage

NOURESS family patents

Family Patents

33. Entresto patents expiration

ENTRESTO's oppositions filed in EPO

ENTRESTO litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8101659 August, 2020 Terminated-Denied Novartis Pharmaceuticals Corporation Biocon Pharma Limited
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8101659 NOVARTIS PHARMS CORP Methods of treatment and pharmaceutical composition
Jan, 2025

(8 months from now)

Drug Exclusivity Drug Exclusivity Expiration
M(M-82) Feb 16, 2024
Pediatric Exclusivity(PED) Apr 01, 2023
New Chemical Entity Exclusivity(NCE) Jul 07, 2020
New Patient Population(NPP) Oct 01, 2022

Drugs and Companies using SACUBITRIL; VALSARTAN ingredient

NCE-1 date: 01 April, 2022

Market Authorisation Date: 07 July, 2015

Treatment: NA

Dosage: TABLET;ORAL

How can I launch a generic of ENTRESTO before it's drug patent expiration?
More Information on Dosage

ENTRESTO family patents

Family Patents

34. Naproxen Sodium patents expiration

NAPROXEN SODIUM's oppositions filed in EPO

NAPROXEN SODIUM litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US11090280 July, 2020 Decision PATHEON SOFTGELS INC
US9693978 January, 2018 Terminated-Denied Patheon Softgels Inc. Catalent Pharma Solutions, Inc.
US9693979 January, 2018 Terminated-Denied Patheon Softgels Inc. Catalent Pharma Solutions, Inc.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9693979 BIONPHARMA Liquid dosage forms of sodium naproxen
Mar, 2026

(1 year, 10 months from now)

US9693978 BIONPHARMA Solvent system for enhancing the solubility of pharmaceutical agents
Mar, 2026

(1 year, 10 months from now)

US11090280 BIONPHARMA Liquid dosage forms of sodium naproxen
Mar, 2026

(1 year, 10 months from now)

Drugs and Companies using NAPROXEN SODIUM ingredient

Market Authorisation Date: 17 February, 2006

Treatment: Temporary reduction of fever

Dosage: CAPSULE;ORAL

How can I launch a generic of NAPROXEN SODIUM before it's drug patent expiration?
More Information on Dosage

NAPROXEN SODIUM family patents

Family Patents

35. Janumet patents expiration

JANUMET's oppositions filed in EPO

JANUMET litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US7326708 June, 2020 Final Written Decision Merck Sharp & Dohme Corp. et al. Sun Pharmaceutical Industries Ltd. et al.
US7326708 June, 2020 Final Written Decision Merck Sharp & Dohme Corp. et al. Dr. Reddy's Laboratories, Inc. et al.
US7326708 June, 2020 Terminated-Settled Merck Sharp & Dohme Corp. Teva Pharmaceuticals USA, Inc.
US7326708 October, 2019 Final Written Decision Merck Sharp & Dohme Corp. et al. Mylan Pharmaceuticals, Inc.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7326708 MSD SUB MERCK Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Nov, 2026

(2 years from now)

Drug Exclusivity Drug Exclusivity Expiration
M(M-187) Dec 04, 2023
Pediatric Exclusivity(PED) Jun 04, 2024
New Chemical Entity Exclusivity(NCE) Oct 16, 2011
M(M-244) Aug 12, 2022

Drugs and Companies using METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE ingredient

NCE-1 date: 05 June, 2023

Market Authorisation Date: 30 March, 2007

Treatment: Method of treating type 2 diabetes mellitus by administering a dipeptidyl peptidase-iv inhibitor

Dosage: TABLET;ORAL

How can I launch a generic of JANUMET before it's drug patent expiration?
More Information on Dosage

JANUMET family patents

Family Patents

36. Janumet Xr patents expiration

JANUMET XR's oppositions filed in EPO

JANUMET XR litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US7326708 June, 2020 Final Written Decision Merck Sharp & Dohme Corp. et al. Sun Pharmaceutical Industries Ltd. et al.
US7326708 June, 2020 Final Written Decision Merck Sharp & Dohme Corp. et al. Dr. Reddy's Laboratories, Inc. et al.
US7326708 June, 2020 Terminated-Settled Merck Sharp & Dohme Corp. Teva Pharmaceuticals USA, Inc.
US7326708 October, 2019 Final Written Decision Merck Sharp & Dohme Corp. et al. Mylan Pharmaceuticals, Inc.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7326708 MSD SUB MERCK Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Nov, 2026

(2 years from now)

Drug Exclusivity Drug Exclusivity Expiration
M(M-187) Dec 04, 2023
Pediatric Exclusivity(PED) Feb 12, 2023
M(M-244) Aug 12, 2022

Drugs and Companies using METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE ingredient

Market Authorisation Date: 02 February, 2012

Treatment: Method of treating type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and metformin hcl extended release is appropriate

Dosage: TABLET, EXTENDED RELEASE;ORAL

How can I launch a generic of JANUMET XR before it's drug patent expiration?
More Information on Dosage

JANUMET XR family patents

Family Patents

37. Januvia patents expiration

JANUVIA's oppositions filed in EPO

JANUVIA litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US7326708 June, 2020 Final Written Decision Merck Sharp & Dohme Corp. et al. Sun Pharmaceutical Industries Ltd. et al.
US7326708 June, 2020 Final Written Decision Merck Sharp & Dohme Corp. et al. Dr. Reddy's Laboratories, Inc. et al.
US7326708 June, 2020 Terminated-Settled Merck Sharp & Dohme Corp. Teva Pharmaceuticals USA, Inc.
US7326708 October, 2019 Final Written Decision Merck Sharp & Dohme Corp. et al. Mylan Pharmaceuticals, Inc.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7326708 MERCK SHARP DOHME Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Nov, 2026

(2 years from now)

Drug Exclusivity Drug Exclusivity Expiration
M(M-187) Dec 04, 2023
Pediatric Exclusivity(PED) Jun 04, 2024
New Chemical Entity Exclusivity(NCE) Oct 16, 2011
M(M-244) Aug 12, 2022

Drugs and Companies using SITAGLIPTIN PHOSPHATE ingredient

NCE-1 date: 05 June, 2023

Market Authorisation Date: 16 October, 2006

Treatment: Method of treating type 2 diabetes mellitus by administering a dipeptidyl peptidase-iv inhibitor

Dosage: TABLET;ORAL

How can I launch a generic of JANUVIA before it's drug patent expiration?
More Information on Dosage

JANUVIA family patents

Family Patents

38. Juvisync patents expiration

JUVISYNC's oppositions filed in EPO

JUVISYNC litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US7326708 June, 2020 Final Written Decision Merck Sharp & Dohme Corp. et al. Sun Pharmaceutical Industries Ltd. et al.
US7326708 June, 2020 Final Written Decision Merck Sharp & Dohme Corp. et al. Dr. Reddy's Laboratories, Inc. et al.
US7326708 June, 2020 Terminated-Settled Merck Sharp & Dohme Corp. Teva Pharmaceuticals USA, Inc.
US7326708 October, 2019 Final Written Decision Merck Sharp & Dohme Corp. et al. Mylan Pharmaceuticals, Inc.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7326708 MERCK SHARP DOHME Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Apr, 2026

(1 year, 11 months from now)

Drugs and Companies using SIMVASTATIN; SITAGLIPTIN PHOSPHATE ingredient

Market Authorisation Date: 18 September, 2012

Treatment: Method of treating type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate

Dosage: TABLET;ORAL

More Information on Dosage

JUVISYNC family patents

Family Patents

39. Steglujan patents expiration

STEGLUJAN's oppositions filed in EPO

STEGLUJAN litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US7326708 June, 2020 Final Written Decision Merck Sharp & Dohme Corp. et al. Sun Pharmaceutical Industries Ltd. et al.
US7326708 June, 2020 Final Written Decision Merck Sharp & Dohme Corp. et al. Dr. Reddy's Laboratories, Inc. et al.
US7326708 June, 2020 Terminated-Settled Merck Sharp & Dohme Corp. Teva Pharmaceuticals USA, Inc.
US7326708 October, 2019 Final Written Decision Merck Sharp & Dohme Corp. et al. Mylan Pharmaceuticals, Inc.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7326708 MSD SUB MERCK Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Nov, 2026

(2 years from now)

Drug Exclusivity Drug Exclusivity Expiration
M(M-275) Sep 17, 2024
New Chemical Entity Exclusivity(NCE) Dec 19, 2022

Drugs and Companies using ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE ingredient

NCE-1 date: 19 December, 2021

Market Authorisation Date: 19 December, 2017

Treatment: An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes

Dosage: TABLET;ORAL

More Information on Dosage

STEGLUJAN family patents

Family Patents

40. Latuda patents expiration

LATUDA litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US9815827 June, 2020 FWD Entered Sumitomo Dainippon Pharma Co., Ltd. Slayback Pharma LLC
US9555027 April, 2017 Terminated-Settled Sumitomo Dainippon Pharma Co., Ltd. Par Pharmaceutical, Inc.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9815827 SUNOVION PHARMS INC Agent for treatment of schizophrenia
Feb, 2024

(a month ago)

US9555027 SUNOVION PHARMS INC Pharmaceutical composition
May, 2026

(2 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Dosing Schedule(D-134) Apr 26, 2015
New Chemical Entity Exclusivity(NCE) Oct 28, 2015
M(M-195) Jan 27, 2020
New Patient Population(NPP) Mar 05, 2021
New Indication(I-674) Jun 28, 2016
Pediatric Exclusivity(PED) Jul 27, 2020

Drugs and Companies using LURASIDONE HYDROCHLORIDE ingredient

NCE-1 date: 28 July, 2019

Market Authorisation Date: 07 December, 2011

Treatment: Treatment of major depressive episodes associated with bipolar i disorder; Treatment of schizophrenia

Dosage: TABLET;ORAL

How can I launch a generic of LATUDA before it's drug patent expiration?
More Information on Dosage

LATUDA family patents

Family Patents

41. Zynrelef Kit patents expiration

ZYNRELEF KIT litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US11083730 May, 2020 Decision Heron Therapeutics, Inc.
US11083797 May, 2020 Decision Heron Therapeutics, Inc.
US10898575 December, 2019 Decision Heron Therapeutics, Inc.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11083730 HERON THERAPS INC Long-acting polymeric delivery systems
Apr, 2035

(11 years from now)

US11083797 HERON THERAPS INC Long-acting polymeric delivery systems
Apr, 2035

(11 years from now)

US10898575 HERON THERAPS INC Long-acting polymeric delivery systems
Apr, 2035

(11 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) May 12, 2024
New Indication(I-933) Jan 23, 2027

Drugs and Companies using BUPIVACAINE; MELOXICAM ingredient

Market Authorisation Date: 12 May, 2021

Treatment: Treatment of postsurgical pain providing analgesia to a patient for up to 72 hours, for example, after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty via soft tissue or periarti...

Dosage: SOLUTION, EXTENDED RELEASE;PERIARTICULAR

More Information on Dosage

ZYNRELEF KIT family patents

Family Patents

42. Orenitram patents expiration

ORENITRAM litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US9593066 March, 2020 Terminated-Denied United Therapeutics Corp. Liquidia Technologies, Inc.
US9604901 March, 2020 FWD Entered United Therapeutics Corp. Liquidia Technolgies, Inc.
US8497393 October, 2015 FWD Entered United Therapeutics Corporation SteadyMed Ltd.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8497393 UNITED THERAP Process to prepare treprostinil, the active ingredient in Remodulin®
Dec, 2028

(4 years from now)

US9593066 UNITED THERAP Process to prepare treprostinil, the active ingredient in remodulin®
Dec, 2028

(4 years from now)

US9604901 UNITED THERAP Process to prepare treprostinil, the active ingredient in Remodulin®
Dec, 2028

(4 years from now)

Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-272) Oct 18, 2026
New Dosage Form(NDF) Dec 20, 2016
New Indication(I-820) Oct 18, 2022
New Dosing Schedule(D-156) Jan 28, 2019
New Dosing Schedule(D-157) Jan 28, 2019
Orphan Drug Exclusivity(ODE-308) Dec 20, 2020

Drugs and Companies using TREPROSTINIL DIOLAMINE ingredient

Market Authorisation Date: 20 December, 2013

Treatment: NA

Dosage: TABLET, EXTENDED RELEASE;ORAL

How can I launch a generic of ORENITRAM before it's drug patent expiration?
More Information on Dosage

ORENITRAM family patents

Family Patents

43. Remodulin patents expiration

REMODULIN litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US9593066 March, 2020 Terminated-Denied United Therapeutics Corp. Liquidia Technologies, Inc.
US9604901 March, 2020 FWD Entered United Therapeutics Corp. Liquidia Technolgies, Inc.
US8497393 October, 2015 FWD Entered United Therapeutics Corporation SteadyMed Ltd.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8497393 UNITED THERAP Process to prepare treprostinil, the active ingredient in Remodulin®
Dec, 2028

(4 years from now)

US9593066 UNITED THERAP Process to prepare treprostinil, the active ingredient in remodulin®
Dec, 2028

(4 years from now)

US9604901 UNITED THERAP Process to prepare treprostinil, the active ingredient in Remodulin®
Dec, 2028

(4 years from now)

Drugs and Companies using TREPROSTINIL ingredient

Market Authorisation Date: 28 September, 2023

Treatment: NA

Dosage: INJECTABLE;IV (INFUSION), SUBCUTANEOUS; SOLUTION;INTRAVENOUS, SUBCUTANEOUS

How can I launch a generic of REMODULIN before it's drug patent expiration?
More Information on Dosage

REMODULIN family patents

Family Patents

44. Invega Sustenna patents expiration

INVEGA SUSTENNA's oppositions filed in EPO

INVEGA SUSTENNA litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US9439906 February, 2020 Terminated-Denied Janssen Pharmaceutica NV Mylan Laboratories Ltd.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9439906 JANSSEN PHARMS Dosing regimen associated with long acting injectable paliperidone esters
Jan, 2031

(6 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Dec 19, 2011
New Indication(I-698) Nov 12, 2017
M(M-215) Dec 20, 2020
New Dosage Form(NDF) Jul 31, 2012
Pediatric Exclusivity(PED) Jan 31, 2013
M(M-119) Aug 29, 2015

Drugs and Companies using PALIPERIDONE PALMITATE ingredient

NCE-1 date: 01 February, 2012

Market Authorisation Date: 31 July, 2009

Treatment: Dosing regimen for the treatment of schizoaffective disorder in adults as a monotherapy and as an adjunct to mood stabilizers or antidepressants by administering two loading doses of paliperidone palm...

Dosage: SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

How can I launch a generic of INVEGA SUSTENNA before it's drug patent expiration?
More Information on Dosage

INVEGA SUSTENNA family patents

Family Patents

45. Dymista patents expiration

DYMISTA's oppositions filed in EPO

DYMISTA litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8163723 January, 2020 Terminated-Denied Cipla Limited GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
US8168620 January, 2020 Terminated-Denied Cipla Limited GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
US9259428 January, 2020 Terminated-Denied Cipla Limited GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
US9901585 January, 2020 Terminated-Denied Cipla Limited GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
US8168620 February, 2017 Terminated-Settled Cipla Limited Argentum Pharmaceuticals LLC
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9259428 MYLAN SPECIALITY LP Combination of azelastine and fluticasone for nasal administration
Jun, 2023

(10 months ago)

US9901585 MYLAN SPECIALITY LP Combination of azelastine and fluticasone for nasal administration
Jun, 2023

(10 months ago)

US8163723 MYLAN SPECIALITY LP Combination of azelastine and steroids
Aug, 2023

(7 months ago)

US8168620 MYLAN SPECIALITY LP Combination of azelastine and steroids
Feb, 2026

(1 year, 10 months from now)

Drug Exclusivity Drug Exclusivity Expiration
New Patient Population(NPP) Feb 20, 2018
Pediatric Exclusivity(PED) Aug 20, 2018
New Combination(NC) May 01, 2015

Drugs and Companies using AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE ingredient

Market Authorisation Date: 01 May, 2012

Treatment: Treatment of seasonal allergic rhinitis; Relief of symptoms associated with seasonal allergic rhinitis

Dosage: SPRAY, METERED;NASAL

How can I launch a generic of DYMISTA before it's drug patent expiration?
More Information on Dosage

DYMISTA family patents

Family Patents

46. Pataday Once Daily Relief patents expiration

PATADAY ONCE DAILY RELIEF litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US9533053 December, 2019 Terminated-Denied Novartis AG AYLA PHARMA LLC
US8791154 June, 2018 Terminated-Settled Alcon Research Ltd. Cipla Limited
US9533053 June, 2018 Terminated-Settled Alcon Research Ltd. Cipla Limited
US8791154 August, 2016 Terminated-Settled Alcon Research, Ltd. Apotex, Inc.
US8791154 February, 2016 Terminated-Settled Alcon Research, Ltd. Argentum Pharmaceuticals, LLC
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8791154 ALCON LABS INC High concentration olopatadine ophthalmic composition
May, 2032

(8 years from now)

US9533053 ALCON LABS INC High concentration olopatadine ophthalmic composition
May, 2032

(8 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Jan 30, 2018
Pediatric Exclusivity(PED) Jul 30, 2018

Drugs and Companies using OLOPATADINE HYDROCHLORIDE ingredient

Market Authorisation Date: 30 January, 2015

Treatment: Treatment of ocular itching associated with allergic conjunctivitis

Dosage: SOLUTION/DROPS;OPHTHALMIC

How can I launch a generic of PATADAY ONCE DAILY RELIEF before it's drug patent expiration?
More Information on Dosage

PATADAY ONCE DAILY RELIEF family patents

Family Patents

47. Cubicin patents expiration

CUBICIN's oppositions filed in EPO

CUBICIN litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US9138456 November, 2019 Terminated-Denied Cubist Pharmaceuticals LLC Amneal Pharmaceuticals LLC
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9138456 CUBIST PHARMS LLC Lipopeptide compositions and related methods
Nov, 2030

(6 years from now)

Drug Exclusivity Drug Exclusivity Expiration
M(M-211) Sep 01, 2020
New Patient Population(NPP) Mar 29, 2020

Drugs and Companies using DAPTOMYCIN ingredient

Market Authorisation Date: 12 September, 2003

Treatment: NA

Dosage: POWDER;INTRAVENOUS

How can I launch a generic of CUBICIN before it's drug patent expiration?
More Information on Dosage

CUBICIN family patents

Family Patents

48. Cubicin Rf patents expiration

CUBICIN RF's oppositions filed in EPO

CUBICIN RF litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US9138456 November, 2019 Terminated-Denied Cubist Pharmaceuticals LLC Amneal Pharmaceuticals LLC
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9138456 CUBIST PHARMS LLC Lipopeptide compositions and related methods
Nov, 2030

(6 years from now)

Drug Exclusivity Drug Exclusivity Expiration
M(M-211) Sep 01, 2020
New Patient Population(NPP) Mar 29, 2020

Drugs and Companies using DAPTOMYCIN ingredient

Market Authorisation Date: 12 September, 2003

Treatment: NA

Dosage: POWDER;INTRAVENOUS

How can I launch a generic of CUBICIN RF before it's drug patent expiration?
More Information on Dosage

CUBICIN RF family patents

Family Patents

49. Bosulif patents expiration

BOSULIF's oppositions filed in EPO

BOSULIF litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US11103497 August, 2019 Decision Becker Hewes
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11103497 PF PRISM CV Treatment of imatinib resistant leukemia
Feb, 2034

(9 years from now)

Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-444) Sep 26, 2030
New Product(NP) Sep 26, 2026
Pediatric Exclusivity(PED) Mar 26, 2027

Drugs and Companies using BOSUTINIB MONOHYDRATE ingredient

Market Authorisation Date: 26 September, 2023

Treatment: A method for treating a bcrabl positive leukemia in a subject that is resistant to imatinib comprising administering to the subject a therapeutically effective amount of bosutinib, wherein the subject...

Dosage: CAPSULE;ORAL; TABLET;ORAL

How can I launch a generic of BOSULIF before it's drug patent expiration?
More Information on Dosage

BOSULIF family patents

Family Patents

50. Aczone patents expiration

ACZONE litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US9517219 June, 2019 FWD Entered Almirall, LLC Mylan Pharmaceuticals Inc.
US9517219 November, 2018 FWD Entered Almirall, LLC Amneal Pharmaceuticals LLC
US9161926 February, 2018 FWD Entered Almirall, LLC Amneal Pharmceuticals LLC
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9517219 ALMIRALL Topical dapsone and dapsone/adapalene compositions and methods for use thereof
Nov, 2033

(9 years from now)

US9161926 ALMIRALL Topical dapsone and dapsone/adaplene compositions and methods for use thereof
Nov, 2033

(9 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Strength(NS) Feb 24, 2019
New Patient Population(NPP) Sep 10, 2022

Drugs and Companies using DAPSONE ingredient

Market Authorisation Date: 24 February, 2016

Treatment: Topical treatment of acne vulgaris

Dosage: GEL;TOPICAL

How can I launch a generic of ACZONE before it's drug patent expiration?
More Information on Dosage

ACZONE family patents

Family Patents

51. Korlym patents expiration

KORLYM litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US10195214 May, 2019 FWD Entered Corcept Therapeutics, Inc. Teva Pharmaceuticals USA, Inc.
US8921348 August, 2018 FWD Entered Corcept Therapeutics Inc. Neptune Generics LLC
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8921348 CORCEPT THERAP Optimizing mifepristone levels in plasma serum of patients suffering from mental disorders treatable with glucocorticoid receptor antagonists
Aug, 2028

(4 years from now)

US10195214 CORCEPT THERAP Concomitant administration of glucocorticoid receptor modulators and CYP3A inhibitors
Jun, 2037

(13 years from now)

Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-22) Feb 17, 2019
New Product(NP) Feb 17, 2015
Orphan Drug Exclusivity(ODE) Feb 17, 2019

Drugs and Companies using MIFEPRISTONE ingredient

Market Authorisation Date: 17 February, 2012

Treatment: Treating cushing's syndrome

Dosage: TABLET;ORAL

How can I launch a generic of KORLYM before it's drug patent expiration?
More Information on Dosage

KORLYM family patents

Family Patents

52. Epinephrine patents expiration

EPINEPHRINE litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US9283197 April, 2019 Terminated-Settled Belcher Pharmaceuticals, LLC Adamis Pharmaceuticals Corporation
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9283197 BPI LABS More potent and less toxic formulations of epinephrine and methods of medical use
Aug, 2034

(10 years from now)

Drugs and Companies using EPINEPHRINE ingredient

Market Authorisation Date: 04 February, 2022

Treatment: Induction and maintenance of mydriasis during intraocular surgery

Dosage: SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS

How can I launch a generic of EPINEPHRINE before it's drug patent expiration?
More Information on Dosage

EPINEPHRINE family patents

Family Patents

53. Imbruvica patents expiration

IMBRUVICA litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US9795604 March, 2019 FWD Entered Pharmacyclics LLC Sandoz Inc.
US8754090 April, 2015 Terminated-Denied Pharmacyclics, Inc. Coalition for Affordable Drugs IV LLC
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8754090 PHARMACYCLICS LLC Use of inhibitors of bruton's tyrosine kinase (Btk)
Jun, 2031

(7 years from now)

US9795604 PHARMACYCLICS LLC Methods of treating and preventing graft versus host disease
Oct, 2034

(10 years from now)

Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-405) Aug 24, 2029
ODE*(ODE*) Aug 02, 2024
New Patient Population(NPP) Aug 24, 2025
Pediatric Exclusivity(PED) Feb 24, 2026
M(M-236) Jan 25, 2022
New Dosing Schedule(D-176) Aug 24, 2021
New Chemical Entity Exclusivity(NCE) Nov 13, 2018

Drugs and Companies using IBRUTINIB ingredient

NCE-1 date: 24 February, 2025

Market Authorisation Date: 16 February, 2018

Treatment: Treatment of mantle cell lymphoma; Treatment of adult patients with chronic graft-versus-host disease (cgvhd) after failure of one or more lines of systemic therapy

Dosage: TABLET;ORAL; SUSPENSION;ORAL; CAPSULE;ORAL

How can I launch a generic of IMBRUVICA before it's drug patent expiration?
More Information on Dosage

IMBRUVICA family patents

Family Patents

54. Tecfidera patents expiration

TECFIDERA's oppositions filed in EPO

TECFIDERA litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8399514 March, 2019 Terminated-Other Biogen MA Inc. Sawai USA, Inc.
US8399514 July, 2018 Final Written Decision on Remand Biogen MA Inc. Mylan Pharmaceuticals Inc. et al.
US8399514 September, 2015 FWD Entered Biogen Idec MA Inc Coalition For Affordable Drugs V LLC
US8399514 May, 2015 Terminated-Denied Biogen MA Inc. Coalition for Affordable Drugs V LLC
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8399514 BIOGEN INC Treatment for multiple sclerosis
Feb, 2028

(3 years from now)

Drug Exclusivity Drug Exclusivity Expiration
M(M-260) Feb 05, 2023
New Chemical Entity Exclusivity(NCE) Mar 27, 2018

Drugs and Companies using DIMETHYL FUMARATE ingredient

NCE-1 date: 27 March, 2017

Market Authorisation Date: 27 March, 2013

Treatment: Method of treating multiple sclerosis

Dosage: CAPSULE, DELAYED RELEASE;ORAL

How can I launch a generic of TECFIDERA before it's drug patent expiration?
More Information on Dosage

TECFIDERA family patents

Family Patents

55. Narcan patents expiration

NARCAN litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US9561177 February, 2019 Institution Denied Opiant Pharmaceuticals, Inc. Nalox-1 Pharmaceuticals, LLC et al.
US9629965 February, 2019 Final Written Decision Opiant Pharmaceuticals, Inc. Nalox-1 Pharmaceuticals, LLC et al.
US9775838 February, 2019 Institution Denied Opiant Pharmaceuticals, Inc. Nalox-1 Pharmaceuticals, LLC et al.
US9468747 February, 2019 Final Written Decision Opiant Pharmaceuticals, Inc. Nalox-1 Pharmaceuticals, LLC et al.
US9211253 February, 2019 Final Written Decision Opiant Pharmaceuticals, Inc. Nalox-1 Pharmaceuticals, LLC et al.
US9468747 February, 2019 Institution Denied Opiant Pharmaceuticals, Inc. Nalox-1 Pharmaceuticals, LLC et al.
US9629965 February, 2019 Institution Denied Opiant Pharmaceuticals, Inc. Nalox-1 Pharmaceuticals, LLC et al.
US9211253 February, 2019 Institution Denied Opiant Pharmaceuticals, Inc. Nalox-1 Pharmaceuticals, LLC et al.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9629965 EMERGENT Nasal drug products and methods of their use
Mar, 2035

(10 years from now)

US9561177 EMERGENT Nasal drug products and methods of their use
Mar, 2035

(10 years from now)

US9468747 EMERGENT Nasal drug products and methods of their use
Mar, 2035

(10 years from now)

US9211253 EMERGENT Nasal drug products and methods of their use
Mar, 2035

(10 years from now)

US9775838 EMERGENT Nasal drug products and methods of their use
Mar, 2035

(10 years from now)

Drugs and Companies using NALOXONE HYDROCHLORIDE ingredient

Market Authorisation Date: 24 January, 2017

Treatment: Use of naloxone hydrochloride for emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Dosage: SPRAY, METERED;NASAL

How can I launch a generic of NARCAN before it's drug patent expiration?
More Information on Dosage

NARCAN family patents

Family Patents

56. Lotemax Sm patents expiration

LOTEMAX SM's oppositions filed in EPO

LOTEMAX SM litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US10596107 January, 2019 Decision Mohannad Shawer et al.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10596107 BAUSCH AND LOMB INC Ophthalmic suspension composition
Dec, 2036

(12 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Strength(NS) Feb 22, 2022

Drugs and Companies using LOTEPREDNOL ETABONATE ingredient

Market Authorisation Date: 22 February, 2019

Treatment: Treatment of post-operative inflammation and pain following ocular surgery

Dosage: GEL;OPHTHALMIC

How can I launch a generic of LOTEMAX SM before it's drug patent expiration?
More Information on Dosage

LOTEMAX SM family patents

Family Patents

57. Onpattro patents expiration

ONPATTRO's oppositions filed in EPO

ONPATTRO litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8058069 January, 2019 Final Written Decision Arbutus Biopharma Corporation Moderna Therapeutics, Inc.
US9364435 March, 2018 FWD Entered Arbutus Biopharma Corporation Moderna Therapeutics, Inc.
Can you believe ONPATTRO received compensation for the extended wait time during the regulatory approval process?
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9364435 ALNYLAM PHARMS INC Lipid formulations for nucleic acid delivery
Apr, 2029

(4 years from now)

US8058069 ALNYLAM PHARMS INC Lipid formulations for nucleic acid delivery
Apr, 2029

(4 years from now)

Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-197) Aug 10, 2025
New Chemical Entity Exclusivity(NCE) Aug 10, 2023

Drugs and Companies using PATISIRAN SODIUM ingredient

NCE-1 date: 10 August, 2022

Market Authorisation Date: 10 August, 2018

Treatment: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis

Dosage: SOLUTION;INTRAVENOUS

More Information on Dosage

ONPATTRO family patents

Family Patents

58. Xyzal Allergy 24hr patents expiration

XYZAL ALLERGY 24HR's oppositions filed in EPO

XYZAL ALLERGY 24HR litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8633194 December, 2018 FWD Entered UCB Biopharma Sprl Apotex Inc.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8633194 CHATTEM SANOFI Pharmaceutical composition of piperazine derivatives
Oct, 2027

(3 years from now)

Drugs and Companies using LEVOCETIRIZINE DIHYDROCHLORIDE ingredient

Market Authorisation Date: 31 January, 2017

Treatment: NA

Dosage: SOLUTION;ORAL

How can I launch a generic of XYZAL ALLERGY 24HR before it's drug patent expiration?
More Information on Dosage

XYZAL ALLERGY 24HR family patents

Family Patents

59. Briviact patents expiration

BRIVIACT litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US10729653 November, 2018 Decision Serge Cuypers et al
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10729653 UCB INC Pharmaceutical compositions comprising 2-oxo-1-pyrrolidine derivatives
Apr, 2030

(5 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Patient Population(NPP) Aug 27, 2024
New Chemical Entity Exclusivity(NCE) May 12, 2021

Drugs and Companies using BRIVARACETAM ingredient

NCE-1 date: 12 May, 2020

Market Authorisation Date: 12 May, 2016

Treatment: NA

Dosage: TABLET;ORAL

How can I launch a generic of BRIVIACT before it's drug patent expiration?
More Information on Dosage

BRIVIACT family patents

Family Patents

60. Kinevac patents expiration

KINEVAC litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US6803046 November, 2018 Terminated-Denied Bracco Diagnostics Inc. Maia Pharmaceuticals, Inc.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6803046 BRACCO Sincalide formulations
Aug, 2022

(1 year, 8 months ago)

Drugs and Companies using SINCALIDE ingredient

Treatment: NA

Dosage: INJECTABLE;INJECTION

More Information on Dosage

KINEVAC family patents

Family Patents

61. Suboxone patents expiration

SUBOXONE's oppositions filed in EPO

SUBOXONE litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US9687454 November, 2018 FWD Entered Indivior UK Limited Dr. Reddy’s Laboratories S.A.
US9687454 November, 2018 Terminated-Denied Indivior UK Limited Dr. Reddy's Laboratories S.A.
US8603514 June, 2017 Terminated-Denied MonoSol Rx, LLC Dr. Reddy’s Laboratories, Inc.
US8603514 June, 2017 Terminated-Denied MonoSol Rx, LLC Par Pharmaceutical, Inc.
US8603514 November, 2016 Terminated-Adverse Judgment MonoSol Rx, LLC Mylan Technologies, Inc.
US8017150 May, 2016 Terminated-Denied MonoSol Rx, LLC Dr. Reddy’s Laboratories, Inc.
US8475832 May, 2016 Terminated-Denied Indivior UK Limited Dr. Reddy’s Laboratories, Inc.
US8603514 May, 2016 Terminated-Denied MonoSol Rx, LLC Dr. Reddy's Laboratories, Inc.
US8017150 December, 2015 Terminated-Denied MONOSOL RX, LLC Teva Parmaceuticals USA Inc.
US8603514 December, 2015 Terminated-Denied MONOSOL RX LLC Teva Pharmaceuticals USA Inc
US8475832 December, 2015 Terminated-Denied Indivior UK Limited Teva Pharmaceuticals USA, Inc.
US8475832 June, 2014 Terminated-Denied RB Pharmaceuticals Limited BioDelivery Sciences International, Inc.
US8475832 January, 2014 FWD Entered RB Pharmaceuticals Limited BioDelivery Sciences International, Inc.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8017150 INDIVIOR Polyethylene oxide-based films and drug delivery systems made therefrom
Feb, 2023

(1 year, 2 months ago)

US8603514 INDIVIOR Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
Apr, 2024

(15 days ago)

US9687454 INDIVIOR Sublingual and buccal film compositions
Aug, 2029

(5 years from now)

US8475832 INDIVIOR Sublingual and buccal film compositions
Mar, 2030

(5 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Dosage Form(NDF) Aug 30, 2013

Drugs and Companies using BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ingredient

Market Authorisation Date: 30 August, 2010

Treatment: Treatment of opioid dependence/sublingual or buccal application; This drug is administered by sublingual route to humans for maintenance treatment of opioid dependence

Dosage: FILM;BUCCAL, SUBLINGUAL

How can I launch a generic of SUBOXONE before it's drug patent expiration?
More Information on Dosage

SUBOXONE family patents

Family Patents

62. Airduo Digihaler patents expiration

AIRDUO DIGIHALER litigations

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US10561808 October, 2018 Decision Declan Walsh et al.
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10561808 TEVA PHARM Dose counter for inhaler having an anti-reverse rotation actuator
Jan, 2032

(7 years from now)

Drug Exclusivity Drug Exclusivity Expiration
M(M-61) Jul 09, 2024
Pediatric Exclusivity(PED) Jan 09, 2025
New Product(NP) Jan 27, 2020

Drugs and Companies using FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE ingredient

Market Authorisation Date: 12 July, 2019

Treatment: NA

Dosage: POWDER;INHALATION

More Information on Dosage

AIRDUO DIGIHALER family patents

Family Patents