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
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 |


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
Sponsor | Phase |
---|---|
German Cancer Research Center | Phase 1/Phase 2 |
Cancer Research Malaysia | Phase 2 |
Pantai Hospital Kuala Lumpur | Phase 2 |
Pharmacology for TALZENNA
Drug Class | Poly(ADP-Ribose) Polymerase Inhibitor |
Mechanism of Action | Poly(ADP-Ribose) Polymerase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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 |