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 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

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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	211651-002	Oct 16, 2018		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-004	Sep 20, 2021		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-003	Sep 20, 2021		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
>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
Argentina	072970	DERIVADOS DEDIHIDROPIRIDOFTALAZINONA, COMPOSICIONES FARMACEUTICAS QUE LOS COMPRENDEN Y USO DE LOS MISMOS EN EL TRATAMIENTO Y/O PREVENCION DE ENFERMEDADES ASOCIADAS CON LA ENZIMA POLI(ADP RIBOSA) POLIMERASA(PARP), TALES COMO CANCER Y ENFERMEDADES VASCULARES, ENTRE OTRAS.	See Plans and Pricing
Japan	2019034951	結晶性（８Ｓ，９Ｒ）−５−フルオロ−８−（４−フルオロフェニル）−９−（１−メチル−１Ｈ−１，２，４−トリアゾール−５−イル）−８，９−ジヒドロ−２Ｈ−ピリド［４，３，２−ｄｅ］フタラジン−３（７Ｈ）−オントシレート塩 (CRYSTALLINE (8S,9R)-5-FLUORO-8-(4-FLUOROPHENYL)-9-(1-METHYL-1H-1,2,4-TRIAZOLE-5-YL)-8,9-DIHYDRO-2H-PYRIDO[4,3,2-DE]PHTHALAZINE-3(7H)-ON TOSYLATE)	See Plans and Pricing
Singapore	193842	DIHYDROPYRIDOPHTHALAZINONE INHIBITORS OF POLY(ADP-RIBOSE)POLYMERASE (PARP)	See Plans and Pricing
>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	54/2019	Austria	See Plans and Pricing	PRODUCT NAME: TALAZOPARIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1377 (MITTEILUNG) 20190624
2767537	132019000000153	Italy	See Plans and Pricing	PRODUCT NAME: TALAZOPARIB(TALZENNA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1377, 20190624
2767537	CA 2019 00055	Denmark	See Plans and Pricing	PRODUCT NAME: TALAZOPARIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT; REG. NO/DATE: EU/1/19/1377 20190624
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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