Pharsight

1. Akeega 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.
US8436185	JANSSEN BIOTECH	Pharmaceutically acceptable salts of 2-{4-[(3S)-piperidin-3-yl]phenyl}-2H-indazole-7-carboxamide	Apr, 2029 (5 years from now)
US8071623	JANSSEN BIOTECH	Amide substituted indazoles as poly(ADP-ribose)polymerase(PARP) inhibitors	Mar, 2031 (7 years from now)
US11673877	JANSSEN BIOTECH	Niraparib compositions	Mar, 2038 (14 years from now)
US11091459	JANSSEN BIOTECH	Niraparib compositions	Mar, 2038 (14 years from now)

Drugs and Companies using ABIRATERONE ACETATE; NIRAPARIB TOSYLATE ingredient

Market Authorisation Date: 11 August, 2023

Treatment: NA

Dosage: TABLET;ORAL

Strength	Dosage	Availability
500MG;EQ 50MG BASE	TABLET;ORAL	Prescription
500MG;EQ 100MG BASE	TABLET;ORAL	Prescription

AKEEGA family patents

2. Balversa 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.
US8895601	JANSSEN BIOTECH	Pyrazolyl quinoxaline kinase inhibitors	Apr, 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).
US9464071	JANSSEN BIOTECH	Pyrazolyl quinoxaline kinase inhibitors	Apr, 2031 (7 years from now)
US9902714	JANSSEN BIOTECH	Quinoxaline derivatives useful as FGFR kinase modulators	Mar, 2035 (11 years from now)
US11684620	JANSSEN BIOTECH	Pharmaceutical compositions comprising N-(3,5-dimethoxyphenyl)-N′-(1-methylethyl)-N-[3-(1-methyl-1H-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-diamine	Feb, 2036 (12 years from now)
US10898482	JANSSEN BIOTECH	Pharmaceutical compositions comprising N-(3,5-dimethoxyphenyl)-N'-1 methylethyl)-N-[3-(1-methyl-1H-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-diamine	Feb, 2036 (12 years from now)
US11077106	JANSSEN BIOTECH	Cancer treatment	Feb, 2038 (14 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Apr 12, 2024

Drugs and Companies using ERDAFITINIB ingredient

NCE-1 date: 2023-04-13

Market Authorisation Date: 12 April, 2019

Treatment: Treatment of adults with locally advanced or metastatic urothelial carcinoma that has susceptible fgfr3 or fgfr2 genetic alterations and progressed during or following prior platinum-containing chemot...

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
3 mg, 4 mg and 5 mg	12 Apr, 2023	1		02 Feb, 2038

Strength	Dosage	Availability
3MG	TABLET;ORAL	Prescription
4MG	TABLET;ORAL	Prescription
5MG	TABLET;ORAL	Prescription

BALVERSA family patents

3. Erleada patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP19169275A	2022-02-04	Generics [UK] Limited	Granted and Under Opposition
EP17187458A	2021-06-02	Sandoz AG	Granted and Under Opposition
EP17187458A	2021-06-02	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP17187458A	2021-06-02	Synthon BV	Granted and Under Opposition
EP18157435A	2021-04-08	SANDOZ AG	Granted and Under Opposition
EP18157435A	2021-04-08	Sagittarius Intellectual Property Consultants Ltd	Granted and Under Opposition
EP13800681A	2019-01-18	Sagittarius Intellectual Property LLP	Granted and Under Opposition
EP13800681A	2019-01-18	Generics (U.K.) Limited	Granted and Under Opposition
EP13800681A	2019-01-18	Luigi, Rumi	Granted and Under Opposition

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.
US9388159	JANSSEN BIOTECH	Substituted diazaspiroalkanes as androgen receptor modulators	Mar, 2027 (3 years from now)
US8445507	JANSSEN BIOTECH	Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases	Sep, 2030 (6 years from now)
US9481663	JANSSEN BIOTECH	Crystalline forms of an androgen receptor modulator	Jun, 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).
US9987261	JANSSEN BIOTECH	Substituted diazaspiroalkanes as androgen receptor modulators	Mar, 2027 (3 years from now)
US8802689	JANSSEN BIOTECH	Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases	Mar, 2027 (3 years from now)
US9884054	JANSSEN BIOTECH	Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer	Sep, 2033 (9 years from now)
US10052314	JANSSEN BIOTECH	Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer	Sep, 2033 (9 years from now)
US10849888	JANSSEN BIOTECH	Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer	Sep, 2033 (9 years from now)
USRE49353	JANSSEN BIOTECH	Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer	Sep, 2033 (9 years from now)
US10702508	JANSSEN BIOTECH	Anti-androgens for the treatment of non-metastatic castration-resistant prostate cancer	Apr, 2038 (14 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Feb 14, 2023

Drugs and Companies using APALUTAMIDE ingredient

NCE-1 date: 2022-02-14

Market Authorisation Date: 14 February, 2018

Treatment: Treatment of non-metastatic, castration-resistant prostate cancer (nm-crpc); Treatment of metastatic castration-sensitive prostate cancer (mcspc); Treatment in combination with a gnrh agonist of non-m...

Dosage: TABLET;ORAL