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Last Updated: June 27, 2022

TALZENNA Drug Patent 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 and is included in one NDA. There are five patents protecting this drug.

This drug has ninety patent family members in thirty 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.

DrugPatentWatch® 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
International Patents:90
US Patents:5
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 52
Clinical Trials: 23
Patent Applications: 738
Drug Prices: Drug price information for TALZENNA
What excipients (inactive ingredients) are in TALZENNA?TALZENNA excipients list
DailyMed Link:TALZENNA at DailyMed
Drug patent expirations by year for TALZENNA
Drug Prices for TALZENNA

See drug prices for TALZENNA

DrugPatentWatch® Estimated 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
German Cancer Research CenterPhase 1/Phase 2
Cancer Research MalaysiaPhase 2
Pantai Hospital Kuala LumpurPhase 2

See all TALZENNA clinical trials

Pharmacology for TALZENNA

US Patents and Regulatory Information for TALZENNA

TALZENNA is protected by five US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TALZENNA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TALZENNA

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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BREAST CANCER SUSCEPTIBILITY GENE (BRCA)-MUTATED (GBRCAM) HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER

FDA Regulatory Exclusivity protecting TALZENNA

NEW CHEMICAL ENTITY
Exclusivity Expiration: 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
Pfizer TALZENNA talazoparib tosylate CAPSULE;ORAL 211651-001 Oct 16, 2018 RX Yes No See Plans and Pricing See Plans and Pricing 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 See Plans and Pricing
Pfizer TALZENNA talazoparib tosylate CAPSULE;ORAL 211651-002 Oct 16, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing 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 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 TALZENNA

When does loss-of-exclusivity occur for TALZENNA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 3502
Estimated Expiration: See Plans and Pricing

Australia

Patent: 11317040
Estimated Expiration: See Plans and Pricing

Patent: 17201564
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2013009117
Estimated Expiration: See Plans and Pricing

Canada

Patent: 14581
Estimated Expiration: See Plans and Pricing

China

Patent: 3282365
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 30146
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 30146
Estimated Expiration: See Plans and Pricing

Patent: 57106
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 51535
Estimated Expiration: See Plans and Pricing

Israel

Patent: 5789
Estimated Expiration: See Plans and Pricing

Patent: 1497
Estimated Expiration: See Plans and Pricing

Japan

Patent: 13540158
Estimated Expiration: See Plans and Pricing

Patent: 17061526
Estimated Expiration: See Plans and Pricing

Patent: 19034951
Estimated Expiration: See Plans and Pricing

Patent: 20169209
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 2563
Estimated Expiration: See Plans and Pricing

Patent: 13004195
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 9490
Estimated Expiration: See Plans and Pricing

Poland

Patent: 30146
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 30146
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 98606
Estimated Expiration: See Plans and Pricing

Patent: 13123036
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 9939
Estimated Expiration: See Plans and Pricing

Patent: 201710578T
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 30146
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1302810
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 140009181
Estimated Expiration: See Plans and Pricing

Patent: 180069132
Estimated Expiration: See Plans and Pricing

Patent: 190120458
Estimated Expiration: See Plans and Pricing

Patent: 210028747
Estimated Expiration: See Plans and Pricing

Spain

Patent: 16600
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 57123
Estimated Expiration: See Plans and Pricing

Patent: 43858
Estimated Expiration: See Plans and Pricing

Patent: 1307345
Estimated Expiration: See Plans and Pricing

Patent: 1713656
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TALZENNA around the world.

Country Patent Number Title Estimated Expiration
Australia 2011317040 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 See Plans and Pricing
Russian Federation 2011108493 ДИГИДРОПИРИДОФТАЛАЗИНОНОВЫЕ ИНГИБИТОРЫ ПОЛИ(АДФ-РИБОЗА)ПОЛИМЕРАЗЫ See Plans and Pricing
South Korea 101846029 See Plans and Pricing
Lithuania C2767537 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TALZENNA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2767537 301021 Netherlands See Plans and Pricing PRODUCT NAME: TALAZOPARIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1377 20190624
2767537 2019042 Norway See Plans and Pricing PRODUCT NAME: TALAZOPARIB, EVENTUELT I FORM AV ET FARMASOEYTISK AKSEPTERBART SALT; REG. NO/DATE: EU/1/19/1377 20190715
2767537 2019C/551 Belgium See Plans and Pricing PRODUCT NAME: TALAZOPARIB, OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/19/1377 20190624
2767537 132019000000153 Italy See Plans and Pricing PRODUCT NAME: TALAZOPARIB(TALZENNA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1377, 20190624
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.