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Talazoparib tosylate - Generic Drug Details

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What are the generic drug sources for talazoparib tosylate and what is the scope of freedom to operate?

Talazoparib tosylate is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Talazoparib tosylate has ninety patent family members in thirty countries.

Two suppliers are listed for this compound.

Summary for talazoparib tosylate

International Patents:	90
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	14
Clinical Trials:	9
Patent Applications:	8
DailyMed Link:	talazoparib tosylate at DailyMed

Recent Clinical Trials for talazoparib tosylate

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

Sponsor	Phase
Pfizer	Phase 2
Stanford University	Phase 2
M.D. Anderson Cancer Center	Phase 1

See all talazoparib tosylate clinical trials

Pharmacology for talazoparib tosylate

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

US Patents and Regulatory Information for talazoparib tosylate

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	211651-002	Oct 16, 2018		RX	Yes	Yes			Y	Y
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-002	Oct 16, 2018		RX	Yes	Yes			Y	Y
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-001	Oct 16, 2018		RX	Yes	No
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-002	Oct 16, 2018		RX	Yes	Yes			Y	Y
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-001	Oct 16, 2018		RX	Yes	No			Y	Y
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-002	Oct 16, 2018		RX	Yes	Yes			Y	Y

International Patents for talazoparib tosylate

Country	Patent Number	Estimated Expiration
Russian Federation	2011108493
European Patent Office	2326650
Slovenia	2767537
Netherlands	301021
Israel	271497
World Intellectual Property Organization (WIPO)	2010017055

Supplementary Protection Certificates for talazoparib tosylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2767537	132019000000153	Italy		PRODUCT NAME: TALAZOPARIB(TALZENNA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1377, 20190624
2767537	2019/060	Ireland		PRODUCT NAME: TALAZOPARIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT.; NAT REGISTRATION NO/DATE: EU/1/19/1377/001 EU/1/19/1377/006 20190620; FIRST REGISTRATION NO/DATE: EU/1/19/1377/001 EU/1/19/1377/006 20190620 (20200708)
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	19C1071	France		PRODUCT NAME: TALAZOPARIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/19/1377 20190624
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	C201930072	Spain		PRODUCT NAME: TALAZOPARIB, OPCIONALMENTE EN FORMA DE SAL FARMACEUTICAMENTE ACEPTABLE; NATIONAL AUTHORISATION NUMBER: EU/1/19/1377; DATE OF AUTHORISATION: 20190620; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1377; DATE OF FIRST AUTHORISATION IN EEA: 20190620