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Last Updated: May 6, 2024

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^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial Dosage: CAPSULE;ORAL
Generic Entry Dates for talazoparib tosylate^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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
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

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	211651-006	Jun 20, 2023		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-002	Mar 7, 2024		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-004	Mar 7, 2024		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-001	Mar 7, 2024		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
>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
Poland	2630146		⤷ Try a Trial
Hungary	E035295		⤷ Try a Trial
South Korea	20140009181	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	⤷ Try a Trial
Lithuania	C2767537		⤷ Try a Trial
>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	PA2019522,C2767537	Lithuania	⤷ Try a Trial	PRODUCT NAME: TALAZOPARIBAS; REGISTRATION NO/DATE: EU/1/19/1377 20190620
2767537	PA2019522	Lithuania	⤷ Try a Trial	PRODUCT NAME: TALAZOPARIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALU; REGISTRATION NO/DATE: EU/1/19/1377 20190620
2767537	C201930072	Spain	⤷ Try a Trial	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	C20190041 00311	Estonia	⤷ Try a Trial	PRODUCT NAME: TALASOPARIIB;REG NO/DATE: EU/1/19/1377 24.06.2019
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.