TALAZOPARIB TOSYLATE - Generic Drug Details

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 two NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Talazoparib tosylate has ninety-five patent family members in thirty-one countries.

Two suppliers are listed for this compound.

Summary for TALAZOPARIB TOSYLATE

International Patents:	95
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	10
Patent Applications:	95
DailyMed Link:	TALAZOPARIB TOSYLATE at DailyMed

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

Dosage:

CAPSULE;ORAL

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 TALAZOPARIB TOSYLATE

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

Sponsor	Phase
Stanford University	Phase 2
Roswell Park Cancer Institute	Phase 1
Pfizer	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	211651-005	Jun 20, 2023		RX	Yes	No
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-003	Mar 7, 2024		RX	Yes	No
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-003	Sep 20, 2021		RX	Yes	No			Y	Y
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-003	Mar 7, 2024		RX	Yes	No			Y	Y
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-001	Oct 16, 2018		RX	Yes	No
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-005	Mar 7, 2024		RX	Yes	No			Y	Y

International Patents for TALAZOPARIB TOSYLATE

Country	Patent Number	Title	Estimated Expiration
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)
Portugal	2630146
Slovenia	2767537
World Intellectual Property Organization (WIPO)	2012054698
Russian Federation	2598606	КРИСТАЛЛИЧЕСКАЯ ТОЗИЛАТНАЯ СОЛЬ (8S,9R)-5-ФТОР-8-(4-ФТОРФЕНИЛ)-9-(1-МЕТИЛ-1Н-1,2,4-ТРИАЗОЛ-5-ИЛ)-8-9-ДИГИДРО-2Н-ПИРИДО[4,3,2-de]ФТАЛАЗИН-3(7Н)-ОНА (CRYSTALLINE TOSYLATE SALT (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)
Lithuania	C2767537

Supplementary Protection Certificates for TALAZOPARIB TOSYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2767537	1990055-4	Sweden		PRODUCT NAME: TALAZOPARIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/DATE: EU/1/19/1377 20190624
2767537	C02767537/01	Switzerland		PRODUCT NAME: TALAZOPARIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67141 12.12.2019
2767537	122019000108	Germany		PRODUCT NAME: TALAZOPARIB ODER PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1377 20190620
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
2767537	SPC/GB19/070	United Kingdom		PRODUCT NAME: TALAZOPARIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, SUCH AS THE TOSYLATE SALT; REGISTERED: UK EU/1/19/1377 (NI) 20190624; UK PLGB00057-1672 20190624; UK PLGB00057-1673 20190624
2767537	CR 2019 00055	Denmark		PRODUCT NAME: TALAZOPARIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT; REG. NO/DATE: EU/1/19/1377 20190624