Pharsight

Drugs facing NCE-1 in 2028

1. Fetroja patents expiration

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.
US9238657 SHIONOGI INC Cephalosporin having catechol group
Nov, 2033

(9 years from now)

US10004750 SHIONOGI INC Salt of cephalosporin derivative, its crystalline solid and a method of manufacturing thereof
Sep, 2035

(11 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).
US9949982 SHIONOGI INC Preparation containing cephalosporin having a catechol moiety
Sep, 2035

(11 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Nov 14, 2024
Generating Antibiotic Incentives Now(GAIN) Nov 14, 2029
New Indication(I-844) Sep 25, 2023

Drugs and Companies using CEFIDEROCOL SULFATE TOSYLATE ingredient

NCE-1 date: 14 November, 2028

Market Authorisation Date: 14 November, 2019

Treatment: Method of treating hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (habp/vabp) comprising administering cefiderocol sulfate tosylate

Dosage: POWDER;INTRAVENOUS

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FETROJA family patents

Family Patents

2. Jakafi patents expiration

JAKAFI's oppositions filed in EPO
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.
US9662335 INCYTE CORP Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as janus kinase inhibitors
Dec, 2026

(2 years from now)

US8415362 INCYTE CORP Pyrazolyl substituted pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors
Dec, 2027

(3 years from now)

US7598257 INCYTE CORP Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as janus kinase inhibitors
Dec, 2027

(3 years from now)

US8722693 INCYTE CORP Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Jun, 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).
US9814722 INCYTE CORP Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as janus kinase inhibitors
Dec, 2026

(2 years from now)

US9079912 INCYTE CORP Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors
Dec, 2026

(2 years from now)

US9079912

(Pediatric)

INCYTE CORP Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors
Jun, 2027

(3 years from now)

US9814722

(Pediatric)

INCYTE CORP Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as janus kinase inhibitors
Jun, 2027

(3 years from now)

US8822481 INCYTE CORP Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Jun, 2028

(4 years from now)

US10016429 INCYTE CORP Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Jun, 2028

(4 years from now)

US8829013 INCYTE CORP Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Jun, 2028

(4 years from now)

US7598257

(Pediatric)

INCYTE CORP Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as janus kinase inhibitors
Jun, 2028

(4 years from now)

US8415362

(Pediatric)

INCYTE CORP Pyrazolyl substituted pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors
Jun, 2028

(4 years from now)

US8722693

(Pediatric)

INCYTE CORP Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Dec, 2028

(4 years from now)

US10016429

(Pediatric)

INCYTE CORP Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Dec, 2028

(4 years from now)

US8822481

(Pediatric)

INCYTE CORP Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Dec, 2028

(4 years from now)

US8829013

(Pediatric)

INCYTE CORP Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Dec, 2028

(4 years from now)

Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-238) May 24, 2026
New Indication(I-872) Sep 22, 2024
M(M-285) Dec 19, 2025
Orphan Drug Exclusivity(ODE-373) Sep 22, 2028
Pediatric Exclusivity(PED) Mar 22, 2029
New Indication(I-799) May 24, 2022
New Indication(I-699) Dec 04, 2017
Orphan Drug Exclusivity(ODE-19) Nov 16, 2018
Orphan Drug Exclusivity(ODE-79) Dec 04, 2021
Orphan Drug Exclusivity(ODE) Nov 16, 2018
New Chemical Entity Exclusivity(NCE) Nov 16, 2016

Drugs and Companies using RUXOLITINIB PHOSPHATE ingredient

NCE-1 date: 22 March, 2028

Market Authorisation Date: 16 November, 2011

Treatment: For treatment of steroid-refractory acute graft-versus-host disease (agvhd); For treatment of polycythemia vera (pv) in patients who have had an inadequate response to or are intolerant of hydroxyurea...

Dosage: TABLET;ORAL

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

Family Patents

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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3. Recarbrio patents expiration

Can you believe RECARBRIO 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 protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8487093 MSD MERCK CO β-lactamase inhibitors
Nov, 2029

(5 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jul 16, 2024
Generating Antibiotic Incentives Now(GAIN) Jul 16, 2029

Drugs and Companies using CILASTATIN SODIUM; IMIPENEM; RELEBACTAM ingredient

NCE-1 date: 16 July, 2028

Market Authorisation Date: 16 July, 2019

Treatment: Treatment of complicated urinary tract infections, including pyelonephritis (cuti)

Dosage: POWDER;INTRAVENOUS

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RECARBRIO family patents

Family Patents

4. Rezdiffra patents expiration

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.
US7452882 MADRIGAL Thyroid hormone analogs
Sep, 2026

(2 years from now)

US9266861 MADRIGAL Method of synthesizing thyroid hormone analogs and polymorphs thereof
Sep, 2033

(9 years from now)

US11564926 MADRIGAL Methods of synthesizing thyroid hormone analogs and polymorphs thereof
Sep, 2033

(9 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).
US10376517 MADRIGAL Methods of synthesizing thyroid hormone analogs and polymorphs thereof
Sep, 2033

(9 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Mar 14, 2029

Drugs and Companies using RESMETIROM ingredient

NCE-1 date: 14 March, 2028

Market Authorisation Date: 14 March, 2024

Treatment: Treatment of adults with noncirrhotic nonalcoholic steatohepatitis (nash) with moderate to advanced liver fibrosis (consistent with stages f2 to f3 fibrosis)

Dosage: TABLET;ORAL

More Information on Dosage

REZDIFFRA family patents

Family Patents

5. Tasigna patents expiration

TASIGNA's oppositions filed in EPO
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.
US7169791 NOVARTIS Inhibitors of tyrosine kinases
Jul, 2023

(10 months ago)

US8415363 NOVARTIS Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide
Jul, 2026

(2 years from now)

US8163904 NOVARTIS Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-Benzamide
Aug, 2028

(4 years from now)

US9061029 NOVARTIS Method of treating proliferative disorders and other pathological conditions mediated by Bcr-Abl, c-Kit, DDR1, DDR2 or PDGF-R kinase activity
Apr, 2032

(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).
US7169791 NOVARTIS Inhibitors of tyrosine kinases
Jul, 2023

(10 months ago)

US7169791

(Pediatric)

NOVARTIS Inhibitors of tyrosine kinases
Jan, 2024

(4 months ago)

US8501760 NOVARTIS Pharmaceutical compositions comprising nilotinib or its salt
Jul, 2026

(2 years from now)

US8389537 NOVARTIS Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide
Jul, 2026

(2 years from now)

US8389537

(Pediatric)

NOVARTIS Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide
Jan, 2027

(2 years from now)

US8501760

(Pediatric)

NOVARTIS Pharmaceutical compositions comprising nilotinib or its salt
Jan, 2027

(2 years from now)

US8415363

(Pediatric)

NOVARTIS Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide
Jan, 2027

(2 years from now)

US8293756 NOVARTIS Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate
Sep, 2027

(3 years from now)

US8293756

(Pediatric)

NOVARTIS Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate
Mar, 2028

(3 years from now)

US8163904

(Pediatric)

NOVARTIS Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-Benzamide
Feb, 2029

(4 years from now)

US9061029

(Pediatric)

NOVARTIS Method of treating proliferative disorders and other pathological conditions mediated by Bcr-Abl, c-Kit, DDR1, DDR2 or PDGF-R kinase activity
Oct, 2032

(8 years from now)

Drug Exclusivity Drug Exclusivity Expiration
Pediatric Exclusivity(PED) Mar 23, 2029
Orphan Drug Exclusivity(ODE-171) Mar 22, 2025
Orphan Drug Exclusivity(ODE-172) Mar 22, 2025
Orphan Drug Exclusivity(ODE-380) Sep 23, 2028
New Dosing Schedule(D-170) Dec 22, 2020
New Patient Population(NPP) Mar 22, 2021
New Chemical Entity Exclusivity(NCE) Oct 29, 2012
New Indication(I-627) Jun 17, 2014
Orphan Drug Exclusivity(ODE) Oct 29, 2014

Drugs and Companies using NILOTINIB HYDROCHLORIDE ingredient

NCE-1 date: 23 March, 2028

Market Authorisation Date: 22 March, 2018

Treatment: A method for the treatment of leukemias; Treatment of philadelphia chromosome positive chronic myeloid leukemia (ph+cml); Treatment of philadelphia chromosome positive chronic myeloid leukemia (ph+cml...

Dosage: CAPSULE;ORAL

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

Family Patents

6. Vafseo patents expiration

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.
US8343952 AKEBIA Prolyl hydroxylase inhibitors and methods of use
Aug, 2027

(3 years from now)

US7811595 AKEBIA Prolyl hydroxylase inhibitors and methods of use
Mar, 2028

(3 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Mar 27, 2029

Drugs and Companies using VADADUSTAT ingredient

NCE-1 date: 27 March, 2028

Market Authorisation Date: 27 March, 2024

Treatment: NA

Dosage: TABLET;ORAL

More Information on Dosage

VAFSEO family patents

Family Patents

7. Xenleta patents expiration

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.
US6753445 NABRIVA Pleuromutilin derivatives having antibacterial activity
Jul, 2021

(2 years ago)

US8153689 NABRIVA Pleuromutilin derivatives for the treatment of diseases mediated by microbes
Mar, 2028

(3 years from now)

US8071643 NABRIVA Pleuromutilin derivatives for the treatment of diseases mediated by microbes
Jan, 2029

(4 years from now)

US9120727 NABRIVA Process for the preparation of pleuromutilins
May, 2031

(7 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Aug 19, 2024
Generating Antibiotic Incentives Now(GAIN) Aug 19, 2029

Drugs and Companies using LEFAMULIN ACETATE ingredient

NCE-1 date: 19 August, 2028

Market Authorisation Date: 19 August, 2019

Treatment: Treatment of adults with community-acquired bacterial pneumonia caused by susceptible microorganisms

Dosage: TABLET;ORAL; SOLUTION;INTRAVENOUS

More Information on Dosage

XENLETA family patents

Family Patents

8. Zelsuvmi patents expiration

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.
US8282967 LNHC Nitric oxide-releasing particles for nitric oxide therapeutics and biomedical applications
May, 2026

(2 years from now)

US8956658 LNHC Nitric oxide-releasing particles for nitric oxide therapeutics and biomedical applications
May, 2026

(2 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).
US10376538 LNHC Topical gels and methods of using the same
Aug, 2030

(6 years from now)

US9737561 LNHC Topical gels and methods of using the same
Aug, 2030

(6 years from now)

US9526738 LNHC Topical gels and methods of using the same
Sep, 2031

(7 years from now)

US10265334 LNHC Anhydrous compositions
Jul, 2032

(8 years from now)

US9289442 LNHC Topical compositions
Jul, 2032

(8 years from now)

US9855211 LNHC Topical compositions and methods of using the same
Feb, 2034

(9 years from now)

US11285098 LNHC Topical compositions and methods of using the same
Feb, 2034

(9 years from now)

US10258564 LNHC Topical compositions and methods of using the same
Nov, 2034

(10 years from now)

US10322081 LNHC Topical antiviral compositions and methods of using the same
Jul, 2035

(11 years from now)

US11040006 LNHC Topical antiviral compositions, delivery systems, and methods of using the same
Jul, 2035

(11 years from now)

US11723858 LNHC Topical antiviral compositions, delivery systems, and methods of using the same
Jul, 2035

(11 years from now)

US10736839 LNHC Topical antiviral compositions, delivery systems, and methods of using the same
Jul, 2035

(11 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jan 05, 2029

Drugs and Companies using BERDAZIMER SODIUM ingredient

NCE-1 date: 06 January, 2028

Market Authorisation Date: 05 January, 2024

Treatment: Method of treating skin ailment with nitric oxide releasing macromolecules and hydrophilic gel; Method of application of topical pharmaceutical composition to treat dermatological condition; Method of...

Dosage: GEL;TOPICAL

More Information on Dosage

ZELSUVMI family patents

Family Patents