TALZENNA Drug Patent Profile

When do Talzenna patents expire, and when can generic versions of Talzenna launch?

Talzenna is a drug marketed by Pfizer and is included in two NDAs. There are six patents protecting this drug.

This drug has ninety-seven patent family members in thirty-two countries.

The generic ingredient in TALZENNA is talazoparib tosylate. Two suppliers are listed for this compound. Additional details are available on the talazoparib tosylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Talzenna

Talzenna was eligible for patent challenges on October 16, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 20, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TALZENNA

International Patents:	97
US Patents:	6
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	44
Clinical Trials:	23
Patent Applications:	310
Drug Prices:	Drug price information for TALZENNA
What excipients (inactive ingredients) are in TALZENNA?	TALZENNA excipients list
DailyMed Link:	TALZENNA at DailyMed

See drug prices for TALZENNA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TALZENNA

Constraining patent/regulatory exclusivity:

8,735,392

NDA:

211651

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

8,735,392

NDA:

217439

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TALZENNA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
German Cancer Research Center	Phase 1/Phase 2
University of Malaya	Phase 2
Cancer Research Malaysia	Phase 2

See all TALZENNA clinical trials

Pharmacology for TALZENNA

Drug Class	Poly(ADP-Ribose) Polymerase Inhibitor
Mechanism of Action	Poly(ADP-Ribose) Polymerase Inhibitors

US Patents and Regulatory Information for TALZENNA

TALZENNA is protected by six US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 8,735,392.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-006	Mar 7, 2024		RX	Yes	Yes	9,820,985
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-003	Sep 20, 2021		DISCN	Yes	No	9,820,985
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-006	Jun 20, 2023		DISCN	Yes	No	8,735,392		Y	Y
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-004	Mar 7, 2024		RX	Yes	No	9,820,985
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-005	Mar 7, 2024		RX	Yes	No	10,780,088
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-003	Sep 20, 2021		DISCN	Yes	No	10,189,837		Y	Y
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-004	Mar 7, 2024		RX	Yes	No	8,420,650		Y	Y

International Patents for TALZENNA

When does loss-of-exclusivity occur for TALZENNA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Hungary

Israel

Japan

Mexico

New Zealand

Poland

Portugal

Russian Federation

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TALZENNA around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	083502	SAL TOSILADA DE (8S,9R)-5-FLUORO-8-(4-FLUOROFENIL)-9-(1-METIL-1H-1,2,4-TRIAZOL-5-IL)-8,9-DIHIDRO-2H-PIRIDO[4,3,2-DE]FTALAZIN-3(7H)-ONA CRISTALINA
Australia	2011317040	Crystalline (8S,9R)-5-fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-8,9-dihydro-2H-pyrido[4,3,2-de]phthalazin-3(7H)-one tosylate salt
Australia	2017201564	CRYSTALLINE (8S,9R)-5-FLUORO-8-(4-FLUOROPHENYL)-9-(1-METHYL-1H-1,2,4-TRIAZOL-5-YL)-8,9-DIHYDRO-2H-PYRIDO[4,3,2-DE]PHTHALAZIN-3(7H)-ONE TOSYLATE SALT
Brazil	112013009117	sal tosilato de (8s,9r)-5-fluor-8-(4-fluorefenil)-9-(1-metil-1h-1,2,4-triazol-5-il)-8,9-diidro-2h-pirido[4,3,2-de]ftalazin-3(7h)-ona, método para preparar uma forma cristalina e uso do mesmo,composição farmacêutica e método para tratar um câncer ou um sintoma do mesmo.
Canada	2814581	SEL TOSYLATE DE LA (8S,9R)-5-FLUORO-8-(4-FLUOROPHENYL)-9-(1-METHYL-1H- 1,2,4-TRIAZOL-5-YL)-8,9-DIHYDRO-2H-PYRIDO[4,3,2-DE]PHTALAZIN-3(7H)-ONE CRISTALLIN (CRYSTALLINE (8S,9R)-5-FLUORO-8-(4-FLUOROPHENYL)-9-(1-METHYL-1H-1,2,4-TRIAZOL-5-YL)-8,9-DIHYDRO-2H-PYRIDO[4,3,2-DE]PHTHALAZIN-3(7H)-ONE TOSYLATE SALT)
China	103282365	结晶的(8S,9R)‑5‑氟‑8‑(4‑氟苯基)‑9‑(1‑甲基‑1H‑1,2,4‑三唑‑5‑基)‑8,9‑二氢‑2H‑吡啶并[4,3,2‑de]酞嗪‑3(7H)‑酮甲苯磺酸盐 (Crystalline (8S,9R)--fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-8,9-dihydro-2H-pyrido[4,3,2-de]phthalazin-3(7H)-one tosylate salt)
Cyprus	1123356

Supplementary Protection Certificates for TALZENNA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2767537	CA 2019 00055	Denmark		PRODUCT NAME: TALAZOPARIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT; REG. NO/DATE: EU/1/19/1377 20190624
2767537	301021	Netherlands		PRODUCT NAME: TALAZOPARIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1377 20190624
2767537	PA2019522	Lithuania		PRODUCT NAME: TALAZOPARIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALU; REGISTRATION NO/DATE: EU/1/19/1377 20190620
2767537	LUC00140	Luxembourg		PRODUCT NAME: TALAZOPARIB, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/19/1377 20190624
2767537	2019C/551	Belgium		PRODUCT NAME: TALAZOPARIB, OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/19/1377 20190624
2767537	122019000108	Germany		PRODUCT NAME: TALAZOPARIB ODER PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1377 20190620
2767537	1990055-4	Sweden		PRODUCT NAME: TALAZOPARIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/19/1377, 2019-06-24; PRV HAR FATTAT BESLUT OM RAETTAD SKYDDSTID FOER FOELJANDE TILLAEGGSSKYDD. 2290042-7 2290031-0 1590027-7 1590062-4 2190040-2 2290010-4 1990014-1 2190030-3 1590011-1 1490013-8 1490014-6 1490015-3 1890033-2 1990042-2 1990055-4 SKYDDSTIDEN FOER SAMTLIGA DESSA TILLAEGGSSKYDD AER FOERLAENGD MED EN DAG, I ENLIGHET MED PATENT- OCH MARKNADSDOMSTOLENS BESLUT I PMAE 7804-24. DEN BESLUTADE SKYDDSTIDEN FRAMGAR AV SVENSK PATENTDATABAS.

DrugChatter Q&A for TALZENNA

New patent for pfizer drug talzenna?
Talzenna loss of exclusivity patent expiry generic?
Talzenna patent expiration date?
Talzenna patent expiry 2029?
Talzenna loss of exclusivity date?