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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 eighty patent family members in twenty-eight countries.

Two suppliers are listed for this compound.

Summary for talazoparib tosylate

International Patents:	80
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	8
Clinical Trials:	7
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 1
Roswell Park Cancer Institute	Phase 1
Southwest Oncology Group	Phase 2

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

International Patents for talazoparib tosylate

Country	Patent Number	Estimated Expiration
Taiwan	201307345
Portugal	2326650
Slovenia	2326650
Japan	2020169209
South Korea	101846029

Supplementary Protection Certificates for talazoparib tosylate

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	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	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	PA2019522	Lithuania		PRODUCT NAME: TALAZOPARIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALU; REGISTRATION NO/DATE: EU/1/19/1377 20190620