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Last Updated: February 23, 2020

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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

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

See all TALZENNA clinical trials

Pharmacology for TALZENNA
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   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
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 211651-001 Oct 16, 2018 RX Yes No   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 PA2019522 Lithuania   Start Trial PRODUCT NAME: TALAZOPARIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALU; REGISTRATION NO/DATE: EU/1/19/1377 20190620
2767537 CA 2019 00055 Denmark   Start Trial PRODUCT NAME: TALAZOPARIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT; REG. NO/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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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