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 one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Two suppliers are listed for this compound.

Summary for talazoparib tosylate

International Patents:	91
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	9
Patent Applications:	111
DailyMed Link:	talazoparib tosylate at DailyMed

Recent Clinical Trials for talazoparib tosylate

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

Sponsor	Phase
Stanford University	Phase 2
Pfizer	Phase 1
Roswell Park Cancer Institute	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	211651-003	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	211651-001	Oct 16, 2018		RX	Yes	No
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-001	Oct 16, 2018		RX	Yes	No			Y	Y
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-004	Sep 20, 2021		RX	Yes	No			Y	Y
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-001	Oct 16, 2018		RX	Yes	No			Y	Y

International Patents for talazoparib tosylate

Country	Patent Number	Title	Estimated Expiration
South Korea	20190120458	결정질의 (8S,9R)-5-플루오로-8--9-(1-메틸-1H-1,2,4-트리아졸-5-일)-8,9-디하이드로-2H-피리도[4,3,2-DE]프탈라진-3(7H)-온 토실레이트 염 (8S9R-5--8-4--9-1--1H-124--5--89--2H-[432-DE]-37H- CRYSTALLINE 8S9R-5-FLUORO-8-4-FLUOROPHENYL-9-1-METHYL-1H-124-TRIAZOL-5-YL-89-DIHYDRO-2H-PYRIDO[432-DE]PHTHALAZIN-37H-ONE TOSYLATE SALT)
Cyprus	1115022
Russian Federation	2514937	ДИГИДРОПИРИДОФТАЛАЗИНОНОВЫЕ ИНГИБИТОРЫ ПОЛИ(АДФ-РИБОЗА)ПОЛИМЕРАЗЫ (DIHYDROPYRIDOPHTHALAZINONE INHIBITORS OF POLY(ADP-RIBOSE)POLYMERASE)
Taiwan	I448464
Brazil	PI0917119	composto, composição farmacêutica, métodos para inibir a poli(adp-ribose) polimerase em um paciente, para tratar uma doença, uso de um composto, e, artigo de fabricação.
Portugal	2630146

Supplementary Protection Certificates for talazoparib tosylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2767537	2019042	Norway		PRODUCT NAME: TALAZOPARIB, EVENTUELT I FORM AV ET FARMASOEYTISK AKSEPTERBART SALT; REG. NO/DATE: EU/1/19/1377 20190715
2767537	122019000108	Germany		PRODUCT NAME: TALAZOPARIB ODER PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1377 20190620
2767537	301021	Netherlands		PRODUCT NAME: TALAZOPARIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1377 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
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	408 19-2019	Slovakia		PRODUCT NAME: TALAZOPARIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/19/1377 20190624