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Last Updated: July 6, 2020

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TALZENNA Drug Profile


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When do Talzenna patents expire, and when can generic versions of Talzenna launch?

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-eight patent family members in twenty-eight 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

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Summary for TALZENNA
Drug patent expirations by year for TALZENNA
Drug Prices for TALZENNA

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Generic Entry Opportunity Date for TALZENNA
Generic Entry Date for TALZENNA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Ulrik LassenPhase 2
GlaxoSmithKlinePhase 2
Roche Pharma AGPhase 2

See all TALZENNA clinical trials

Pharmacology for TALZENNA

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

Supplementary Protection Certificates for TALZENNA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2767537 LUC00140 Luxembourg   Start Trial PRODUCT NAME: TALAZOPARIB, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/19/1377 20190624
2767537 1990055-4 Sweden   Start Trial PRODUCT NAME: TALAZOPARIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/DATE: EU/1/19/1377 20190624
2767537 2019C/551 Belgium   Start Trial PRODUCT NAME: TALAZOPARIB, OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/19/1377 20190624
2767537 301021 Netherlands   Start Trial PRODUCT NAME: TALAZOPARIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1377 20190624
2767537 PA2019522 Lithuania   Start Trial PRODUCT NAME: TALAZOPARIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALU; REGISTRATION NO/DATE: EU/1/19/1377 20190620
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Mallinckrodt
Harvard Business School
AstraZeneca
Baxter

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.