Talazoparib tosylate - Generic Drug Details

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What are the generic 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

Generic Entry Dates for talazoparib tosylate^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: CAPSULE;ORAL
Generic Entry Dates for talazoparib tosylate^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Anatomical Therapeutic Chemical (ATC) Classes for talazoparib tosylate

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 talazoparib tosylate

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Glossary

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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	217439-004	Mar 7, 2024		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-005	Jun 20, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-006	Jun 20, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for talazoparib tosylate

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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	⤷ Sign Up
Portugal	2630146		⤷ Sign Up
United Kingdom	0913474		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for talazoparib tosylate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2767537	301021	Netherlands	⤷ Sign Up	PRODUCT NAME: TALAZOPARIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1377 20190624
2767537	19C1071	France	⤷ Sign Up	PRODUCT NAME: TALAZOPARIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/19/1377 20190624
2767537	408 19-2019	Slovakia	⤷ Sign Up	OWNER(S): MEDIVATION TECHNOLOGIES LLC, NEW YORK, NY, US; DATUM ZAPISU DO REGISTRA: 20.1.2022
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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