Pharsight

1. Adenoscan patents expiration

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).
US5731296	ASTELLAS	Selective vasodilation by continuous adenosine infusion	Mar, 2015 (9 years ago)

Drugs and Companies using ADENOSINE ingredient

Market Authorisation Date: 18 May, 1995

Treatment: Selective vasodilation by continuous adenosine infusion

Dosage: SOLUTION;INTRAVENOUS

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
3 mg/mL, 20 mL and 30 mL vials	18 Apr, 2005	1	29 Aug, 2013	24 Mar, 2015	Eligible

Strength	Dosage	Availability
90MG/30ML (3MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;INTRAVENOUS	Discontinued
60MG/20ML (3MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;INTRAVENOUS	Discontinued

ADENOSCAN family patents

2. Ambisome patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5874104	ASTELLAS	Treatment of systemic fungal infections with phospholipid particles encapsulating polyene antibiotics	Feb, 2016 (8 years ago)
US5965156	ASTELLAS	Amphotericin B liposome preparation	Oct, 2016 (7 years ago)

Drugs and Companies using AMPHOTERICIN B ingredient

Market Authorisation Date: 11 August, 1997

Treatment: For the treatment of fungal infections

Dosage: INJECTABLE, LIPOSOMAL;INJECTION

Strength	Dosage	Availability
50MG/VIAL	INJECTABLE, LIPOSOMAL;INJECTION	Prescription

AMBISOME family patents

3. Astagraf Xl patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8551522	ASTELLAS	Sustained-release formulation	Mar, 2019 (5 years ago)
US6884433	ASTELLAS	Sustained release formulation containing tacrolimus	Mar, 2019 (5 years ago)
US6576259	ASTELLAS	Sustained release formulations containing tacrolimus	Mar, 2019 (5 years ago)
US6440458	ASTELLAS	Sustained release preparations	Mar, 2019 (5 years ago)

Drug Exclusivity	Drug Exclusivity Expiration
ODE(ODE)	May 24, 2025
New Dosage Form(NDF)	Jul 19, 2016

Drugs and Companies using TACROLIMUS ingredient

Market Authorisation Date: 19 July, 2013

Treatment: Method of once a day administration

Dosage: CAPSULE, EXTENDED RELEASE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.5 mg, 1 mg, and 5 mg	24 Sep, 2013	1		25 Mar, 2019	Extinguished

Strength	Dosage	Availability
EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription
EQ 1MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription
EQ 5MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription

ASTAGRAF XL family patents

4. Cresemba patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP07802308A	2010-12-03	Basilea Pharmaceutica International AG	Patent maintained as amended

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7459561	ASTELLAS	N-substituted carbamoyloxyalkyl-azolium derivatives	Oct, 2020 (3 years ago)
US10812238	ASTELLAS	Configurable reference signals	Oct, 2025 (1 year, 6 months from now)
US6812238	ASTELLAS	N-substituted carbamoyloxyalkyl-azolium derivatives	Oct, 2025 (1 year, 6 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).
US6812238 (Pediatric)	ASTELLAS	N-substituted carbamoyloxyalkyl-azolium derivatives	May, 2026 (2 years from now)
US10603280	ASTELLAS	Active ingredient containing stabilised solid medicinal forms and methods for the production thereof	Sep, 2027 (3 years from now)
US10206879	ASTELLAS	Active ingredient containing stabilised solid forms and method for the production thereof	Sep, 2027 (3 years from now)
US10206879 (Pediatric)	ASTELLAS	Active ingredient containing stabilised solid forms and method for the production thereof	Mar, 2028 (3 years from now)
US10603280 (Pediatric)	ASTELLAS	Active ingredient containing stabilised solid medicinal forms and methods for the production thereof	Mar, 2028 (3 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-90)	Mar 06, 2022
New Chemical Entity Exclusivity(NCE)	Mar 06, 2020
Orphan Drug Exclusivity(ODE-305)	Mar 06, 2022
Orphan Drug Exclusivity(ODE-458)	Dec 08, 2030
New Patient Population(NPP)	Dec 08, 2026
Orphan Drug Exclusivity(ODE-454)	Dec 08, 2030
ODE(ODE)	Mar 06, 2022
Pediatric Exclusivity(PED)	Jun 08, 2031
Generating Antibiotic Incentives Now(GAIN)	Sep 06, 2027
Orphan Drug Exclusivity(ODE)	Mar 06, 2022

Drugs and Companies using ISAVUCONAZONIUM SULFATE ingredient

NCE-1 date: 08 June, 2030

Market Authorisation Date: 22 November, 2022

Treatment: NA

Dosage: CAPSULE;ORAL; POWDER;INTRAVENOUS

Strength	Dosage	Availability
186MG	CAPSULE;ORAL	Prescription
372MG	POWDER;INTRAVENOUS	Prescription
74.5MG	CAPSULE;ORAL	Prescription

CRESEMBA family patents

5. Lexiscan patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7655637	ASTELLAS	N-pyrazole A2A receptor agonists	Jun, 2019 (4 years ago)
US6642210	ASTELLAS	2-(N-pyrazolo)adenosines with application as adenosine A2A receptor agonists	Jun, 2019 (4 years ago)
US7144872	ASTELLAS	N-pyrazole A2A receptor agonists	Jun, 2019 (4 years ago)
USRE47351	ASTELLAS	2-(N-pyrazolo)adenosines with application as adenosine A2A receptor agonists	Jun, 2019 (4 years ago)
US6403567	ASTELLAS	N-pyrazole A2A adenosine receptor agonists	Apr, 2022 (2 years ago)
US8106183	ASTELLAS	Process for preparing an A2A-adenosine receptor agonist and its polymorphs	Feb, 2027 (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).
US9045519	ASTELLAS	N-pyrazole A2A receptor agonists	Jun, 2019 (4 years ago)
US9289446	ASTELLAS	Myocardial perfusion imaging methods and compositions	Jun, 2019 (4 years ago)
US8133879	ASTELLAS	Myocardial perfusion imaging methods and compositions	Jun, 2019 (4 years ago)
US7183264	ASTELLAS	N-pyrazole A2A receptor agonists	Jun, 2019 (4 years ago)
US8536150	ASTELLAS	Methods of myocardial perfusion imaging	Jun, 2019 (4 years ago)
US8470801	ASTELLAS	Myocardial perfusion imaging methods and compositions	Jun, 2019 (4 years ago)
US8183226	ASTELLAS	Myocardial perfusion imaging method	Jun, 2019 (4 years ago)
US8106029	ASTELLAS	Use of A2A adenosine receptor agonists	Jun, 2019 (4 years ago)
US7655636	ASTELLAS	Use of A2A adenosine receptor agonists	Jun, 2019 (4 years ago)
US7582617	ASTELLAS	Myocardial perfusion imaging method	Jun, 2019 (4 years ago)
US7683037	ASTELLAS	Myocardial perfusion imaging method	Jun, 2019 (4 years ago)
US9085601	ASTELLAS	Process for preparing an A2A-adenosine receptor agonist and its polymorphs	Feb, 2027 (2 years from now)
USRE47301	ASTELLAS	Process for preparing an A2A-adenosine receptor agonist and its polymorphs	Feb, 2027 (2 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
M(M-194)	Jan 17, 2020
New Chemical Entity Exclusivity(NCE)	Apr 10, 2013

Drugs and Companies using REGADENOSON ingredient

NCE-1 date: 10 April, 2012

Market Authorisation Date: 10 April, 2008

Treatment: Method of myocardial imaging; Method for stimulating coronary vasodilation for purposes of imaging the heart; A method of myocardial perfusion imaging and increasing coronary blood flow

Dosage: SOLUTION;INTRAVENOUS

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.08 mg/mL, 5 mL vial	10 Apr, 2012	1		02 Feb, 2027	Extinguished

Strength	Dosage	Availability
0.4MG/5ML (0.08MG/ML)	SOLUTION;INTRAVENOUS	Prescription

LEXISCAN family patents

6. Mycamine patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6265536	ASTELLAS	Cyclic hexapeptides having antibiotic activity	Sep, 2015 (8 years ago)
US6107458	ASTELLAS	Cyclic hexapeptides having antibiotic activity	Mar, 2019 (5 years ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6774104	ASTELLAS	Stabilized pharmaceutical composition in lyophilized form	Jan, 2021 (3 years ago)
US6774104 (Pediatric)	ASTELLAS	Stabilized pharmaceutical composition in lyophilized form	Jul, 2021 (2 years ago)

Drug Exclusivity	Drug Exclusivity Expiration
Pediatric Exclusivity(PED)	Jun 20, 2023
New Indication(I-821)	Dec 20, 2022

Drugs and Companies using MICAFUNGIN SODIUM ingredient

Market Authorisation Date: 16 March, 2005

Treatment: Treatment of patients with candidemia, acute disseminated candidiasis, candida peritonitis and abscesses; Treatment of esophageal candidiasis and prophylaxis of candida infections in hsct patients

Dosage: INJECTABLE;INTRAVENOUS

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
50 mg/vial 100 mg/vial	16 Jun, 2014	1	17 May, 2019	08 Jan, 2021	Eligible

Strength	Dosage	Availability
EQ 100MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription
EQ 50MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription

MYCAMINE family patents

7. Veozah patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8871761	ASTELLAS	NK-3 receptor selective antagonist compounds, pharmaceutical composition and methods for use in NK-3 receptors mediated disorders	Apr, 2031 (6 years from now)
US9422299	ASTELLAS	Substituted [1,2,4]triazolo[4,3-a]pyrazines as selective NK-3 receptor antagonists	Mar, 2034 (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).
US9987274	ASTELLAS	N-acyl-(3-substituted)-(8-substituted)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazines as selective NK-3 receptor antagonists	Mar, 2034 (9 years from now)
US10836768	ASTELLAS	N-acyl-(3-substituted)-(8-substituted)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazines as selective NK-3 receptor antagonists	Mar, 2034 (9 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	May 12, 2028

Drugs and Companies using FEZOLINETANT ingredient

NCE-1 date: 13 May, 2027

Market Authorisation Date: 12 May, 2023

Treatment: Treatment of moderate to severe vasometer symptoms due to menopause; Treatment of moderate to severe vasomotor symptoms due with menopause

Dosage: TABLET;ORAL

Strength	Dosage	Availability
45MG	TABLET;ORAL	Prescription

VEOZAH family patents

8. Vesicare patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6017927	ASTELLAS	Quinuclidine derivatives and medicinal composition thereof	Nov, 2018 (5 years ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6017927 (Pediatric)	ASTELLAS	Quinuclidine derivatives and medicinal composition thereof	May, 2019 (4 years ago)

Drugs and Companies using SOLIFENACIN SUCCINATE ingredient

Market Authorisation Date: 19 November, 2004

Treatment: NA

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
5 mg and 10 mg	08 Apr, 2009	1	02 Apr, 2014	09 Nov, 2018	Deferred

Strength	Dosage	Availability
10MG	TABLET;ORAL	Prescription
5MG	TABLET;ORAL	Prescription

VESICARE family patents

9. Vesicare Ls patents expiration

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).
US9918970	ASTELLAS	Pharmaceutical composition comprising solifenacin	May, 2031 (7 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Pediatric Exclusivity(PED)	Nov 26, 2023
New Product(NP)	May 26, 2023
W(W)	Nov 26, 2023

Drugs and Companies using SOLIFENACIN SUCCINATE ingredient

Market Authorisation Date: 26 May, 2020

Treatment: NA

Dosage: SUSPENSION;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
1 mg/mL	27 May, 2021	1		18 May, 2031

Strength	Dosage	Availability
1MG/ML	SUSPENSION;ORAL	Prescription

VESICARE LS family patents

10. Xospata patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8969336	ASTELLAS	Diamino heterocyclic carboxamide compound	Jan, 2031 (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).
US9487491	ASTELLAS	Diamino heterocyclic carboxamide compound	Jul, 2030 (6 years from now)
US10786500	ASTELLAS	Stable pharmaceutical composition for oral administration	Jul, 2036 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-222)	Nov 28, 2025
New Chemical Entity Exclusivity(NCE)	Nov 28, 2023

Drugs and Companies using GILTERITINIB FUMARATE ingredient

NCE-1 date: 28 November, 2022

Market Authorisation Date: 28 November, 2018

Treatment: Treatment of acute myeloid leukemia (aml)

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
40 mg	28 Nov, 2022	1		01 Jul, 2036

Strength	Dosage	Availability
EQ 40MG BASE	TABLET;ORAL	Prescription

XOSPATA family patents

11. Xtandi patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP11184401A	2015-12-18	Generics (U.K.) Limited	Revoked
EP06748863A	2012-10-18	Fickert, Stefan	Patent maintained as amended

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7709517	ASTELLAS	Diarylhydantoin compounds	Aug, 2027 (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).
US9126941	ASTELLAS	Treatment of hyperproliferative disorders with diarylhydantoin compounds	May, 2026 (2 years from now)
US8183274	ASTELLAS	Treatment of hyperproliferative disorders with diarylhydantoin compounds	Aug, 2026 (2 years from now)
US11839689	ASTELLAS	Formulations of enzalutamide	Sep, 2033 (9 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-926)	Nov 17, 2026
New Indication(I-786)	Jul 13, 2021
New Indication(I-693)	Sep 10, 2017
New Indication(I-808)	Dec 16, 2022
New Chemical Entity Exclusivity(NCE)	Aug 31, 2017

Drugs and Companies using ENZALUTAMIDE ingredient

NCE-1 date: 31 August, 2016

Market Authorisation Date: 31 August, 2012

Treatment: Treatment of patients with non-metastatic castration-sensitive prostate cancer (nmcspc) with biochemical recurrence (bcr) at high risk for metastasis

Dosage: TABLET;ORAL

Pharsight

Astellas patents expiration

1. Adenoscan patents expiration

ADENOSCAN family patents

2. Ambisome patents expiration

AMBISOME family patents

3. Astagraf Xl patents expiration

ASTAGRAF XL family patents

4. Cresemba patents expiration

CRESEMBA family patents

5. Lexiscan patents expiration

LEXISCAN family patents

6. Mycamine patents expiration

MYCAMINE family patents

7. Veozah patents expiration

VEOZAH family patents

8. Vesicare patents expiration

VESICARE family patents

9. Vesicare Ls patents expiration

VESICARE LS family patents

10. Xospata patents expiration

XOSPATA family patents

11. Xtandi patents expiration

XTANDI family patents

Related content

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
40 mg	31 Aug, 2016	3	14 May, 2021	13 Aug, 2027	Deferred
40 mg and 80 mg	31 Mar, 2021	1		13 Aug, 2027