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TALZENNA Drug Profile

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When do Talzenna patents expire, and what generic alternatives are available?

Talzenna is a drug marketed by Pfizer Inc and is included in one NDA. There are five patents protecting this drug.

This drug has seventy-four patent family members in twenty-seven countries.

The generic ingredient in TALZENNA is talazoparib tosylate. Two suppliers are listed for this compound. Additional details are available on the talazoparib tosylate profile page.

US ANDA Litigation and Generic Entry Outlook for Talzenna

Talzenna will be eligible for patent challenges on October 16, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 20, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TALZENNA

International Patents:	74
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	44
Clinical Trials:	9
Patent Applications:	39
Drug Prices:	Drug price information for TALZENNA
DailyMed Link:	TALZENNA at DailyMed

See drug prices for TALZENNA

Generic Entry Opportunity Date for TALZENNA

NDA:

211651

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 TALZENNA

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
Southwest Oncology Group	Phase 2
National Cancer Institute (NCI)	Phase 1/Phase 2

See all TALZENNA clinical trials

Pharmacology for TALZENNA

Drug Class	Poly(ADP-Ribose) Polymerase Inhibitor
Mechanism of Action	Poly(ADP-Ribose) Polymerase Inhibitors

Synonyms for TALZENNA

(8S,9R)-5-Fluoro-8-(4-fluorophenyl)-2,7,8,9-tetrahydro-9-(1-methyl-1H-1,2,4-triazol-5-yl)-3H-pyrido[4,3,2-de]phthalazine-3-one

(8s,9r)-5-Fluoro-8-(4-Fluorophenyl)-9-(1-Methyl-1h-1,2,4-Triazol-5-Yl)-2,7,8,9-Tetrahydro-3h-Pyrido[4,3,2-De]phthalazin-3-One

(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

1207456-01-6

3H-Pyrido(4,3,2-de)phthalazin-3-one, 5-fluoro-8-(4-fluorophenyl)-2,7,8,9-tetrahydro-9-(1-methyl-1H-1,2,4-triazol-5-yl)-, (8S,9R)-

4pjt

9QHX048FRV

ACN-053048

AOB5705

BC600324

BDBM50084621

BMN 673

BMN-673

BMN673

BMN673,BMN-673

CHEMBL3137320

CS-0937

D10732

DB11760

EX-A1356

FT-0701676

GTPL8313

HWGQMRYQVZSGDQ-HZPDHXFCSA-N

HY-16106

LT 00673

LT-673

NCGC00390231-01

QC-4556

S-7826

S7048

SB16478

SC-91523

SCHEMBL2299348

SW219655-1

Talazoparib

Talazoparib (BMN 673)

Talazoparib (USAN/INN)

Talazoparib [USAN:INN]

Talazoparib(BMN-673)

UNII-9QHX048FRV

X5821

ZINC138126699

ZINC72318110

US Patents and Regulatory Information for TALZENNA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer Inc	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-001	Oct 16, 2018		RX	Yes	No
Pfizer Inc	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-002	Oct 16, 2018		RX	Yes	Yes
Pfizer Inc	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-001	Oct 16, 2018		RX	Yes	No			Y	Y
Pfizer Inc	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-002	Oct 16, 2018		RX	Yes	Yes
Pfizer Inc	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-002	Oct 16, 2018		RX	Yes	Yes			Y	Y
Pfizer Inc	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-001	Oct 16, 2018		RX	Yes	No			Y	Y
Pfizer Inc	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-001	Oct 16, 2018		RX	Yes	No			Y	Y

International Patents for TALZENNA

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2012054698
Hong Kong	1200813
Russian Federation	2011108493
Cyprus	1119218
Taiwan	I557123
Spain	2466565
South Africa	201100897

Supplementary Protection Certificates for TALZENNA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2767537	PA2019522	Lithuania		PRODUCT NAME: TALAZOPARIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALU; REGISTRATION NO/DATE: EU/1/19/1377 20190620
2767537	CA 2019 00055	Denmark		PRODUCT NAME: TALAZOPARIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT; REG. NO/DATE: EU/1/19/1377 20190624
2767537	301021	Netherlands		PRODUCT NAME: TALAZOPARIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1377 20190624