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 six patents protecting this drug.
This drug has ninety-three 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 was eligible for patent challenges on October 16, 2022.
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: | 93 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 23 |
Patent Applications: | 799 |
Drug Prices: | Drug price information for TALZENNA |
What excipients (inactive ingredients) are in TALZENNA? | TALZENNA excipients list |
DailyMed Link: | TALZENNA at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 |
Pantai Hospital Kuala Lumpur | Phase 2 |
Hospital Sultan Ismail | 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 six US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TALZENNA is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH HRR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) IN COMBINATION WITH ENZALUTAMIDE
Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
USE OF TALAZOPARIB IN COMBINATION WITH ENZALUTAMIDE FOR THE TREATMENT OF ADULT PATIENTS WITHHOMOLOGOUS RECOMBINATION REPAIR (HRR) GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC).
Exclusivity Expiration: ⤷ Try a Trial
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 | 211651-002 | Oct 16, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Pfizer | TALZENNA | talazoparib tosylate | CAPSULE;ORAL | 211651-004 | Sep 20, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Pfizer | TALZENNA | talazoparib tosylate | CAPSULE;ORAL | 211651-003 | Sep 20, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Pfizer | TALZENNA | talazoparib tosylate | CAPSULE;ORAL | 211651-004 | Sep 20, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Pfizer | TALZENNA | talazoparib tosylate | CAPSULE;ORAL | 211651-003 | Sep 20, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
>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: ⤷ Try a Trial
Australia
Patent: 11317040
Estimated Expiration: ⤷ Try a Trial
Patent: 17201564
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2013009117
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 14581
Estimated Expiration: ⤷ Try a Trial
China
Patent: 3282365
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 23356
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 30146
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 30146
Estimated Expiration: ⤷ Try a Trial
Patent: 57106
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 51535
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 5789
Estimated Expiration: ⤷ Try a Trial
Patent: 1497
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 13540158
Estimated Expiration: ⤷ Try a Trial
Patent: 17061526
Estimated Expiration: ⤷ Try a Trial
Patent: 19034951
Estimated Expiration: ⤷ Try a Trial
Patent: 20169209
Estimated Expiration: ⤷ Try a Trial
Patent: 22140637
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 2563
Estimated Expiration: ⤷ Try a Trial
Patent: 13004195
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 9490
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 30146
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 30146
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 98606
Estimated Expiration: ⤷ Try a Trial
Patent: 13123036
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 9939
Estimated Expiration: ⤷ Try a Trial
Patent: 201710578T
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 30146
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1302810
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 140009181
Estimated Expiration: ⤷ Try a Trial
Patent: 180069132
Estimated Expiration: ⤷ Try a Trial
Patent: 190120458
Estimated Expiration: ⤷ Try a Trial
Patent: 210028747
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 16600
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 57123
Estimated Expiration: ⤷ Try a Trial
Patent: 43858
Estimated Expiration: ⤷ Try a Trial
Patent: 1307345
Estimated Expiration: ⤷ Try a Trial
Patent: 1713656
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Denmark | 2767537 | ⤷ Try a Trial | |
Denmark | 2630146 | ⤷ Try a Trial | |
Israel | 211070 | דיהידרופירידופתאלאזינון כמעקב של פולי (adp-ריבוז)פולימראז (Dihydropyridophthalazinone inhibitors of poly(adp-ribose)polymerase) | ⤷ Try a Trial |
European Patent Office | 3757106 | SEL TOSYLATE DE LA (8S,9R)-5-FLUORO-8-(4-FLUOROPHÉNYL)-9-(1-MÉTHYL-1H- 1,2,4-TRIAZOL-5-YL)-8,9-DIHYDRO-2H-PYRIDO[4,3,2-DE]PHTALAZIN-3(7H)-ONE CRISTALLIN (CRYSTALINE (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]PHTALAZIN-3(7H)-ONE TOSYLATE SALT) | ⤷ Try a Trial |
Hungary | S1900053 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TALZENNA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2767537 | 2019042 | Norway | ⤷ Try a Trial | PRODUCT NAME: TALAZOPARIB, EVENTUELT I FORM AV ET FARMASOEYTISK AKSEPTERBART SALT; REG. NO/DATE: EU/1/19/1377 20190715 |
2767537 | CR 2019 00055 | Denmark | ⤷ Try a Trial | PRODUCT NAME: TALAZOPARIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT; REG. NO/DATE: EU/1/19/1377 20190624 |
2767537 | C02767537/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: TALAZOPARIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67141 12.12.2019 |
2767537 | LUC00140 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: TALAZOPARIB, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/19/1377 20190624 |
2767537 | 2019/060 | Ireland | ⤷ Try a Trial | PRODUCT NAME: TALAZOPARIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT.; NAT REGISTRATION NO/DATE: EU/1/19/1377/001 EU/1/19/1377/006 20190620; FIRST REGISTRATION NO/DATE: EU/1/19/1377/001 EU/1/19/1377/006 20190620 (20200708) |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |