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 one NDA. There are five patents protecting this drug.

This drug has ninety patent family members in thirty 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 will be eligible for patent challenges on October 16, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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:	90
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	23
Patent Applications:	738
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 Generic Entry Opportunity Date for TALZENNA

NDA:

211651

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
Cancer Research Malaysia	Phase 2
Pantai Hospital Kuala Lumpur	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

Anatomical Therapeutic Chemical (ATC) Classes for TALZENNA

L01XK	Poly (ADP-ribose) polymerase (PARP) inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for TALZENNA

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

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

Patents protecting TALZENNA

FDA Regulatory Exclusivity protecting TALZENNA

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	211651-001	Oct 16, 2018		RX	Yes	No
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-004	Sep 20, 2021		RX	Yes	No
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-002	Oct 16, 2018		RX	Yes	Yes
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-003	Sep 20, 2021		RX	Yes	No

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

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
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
Russian Federation	2011108493	ДИГИДРОПИРИДОФТАЛАЗИНОНОВЫЕ ИНГИБИТОРЫ ПОЛИ(АДФ-РИБОЗА)ПОЛИМЕРАЗЫ
South Korea	101846029
Lithuania	C2767537

Supplementary Protection Certificates for TALZENNA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2767537	301021	Netherlands		PRODUCT NAME: TALAZOPARIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1377 20190624
2767537	2019042	Norway		PRODUCT NAME: TALAZOPARIB, EVENTUELT I FORM AV ET FARMASOEYTISK AKSEPTERBART SALT; REG. NO/DATE: EU/1/19/1377 20190715
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	132019000000153	Italy		PRODUCT NAME: TALAZOPARIB(TALZENNA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1377, 20190624