TALZENNA Drug Patent Profile
When do Talzenna patents expire, and when can generic versions of Talzenna launch?
Talzenna is a drug marketed by Pfizer and is included in two NDAs. There are six patents protecting this drug.
The generic ingredient in TALZENNA is talazoparib tosylate. There is one drug master file entry for this compound. 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 16, 2032. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for TALZENNA?
- What are the global sales for TALZENNA?
- What is Average Wholesale Price for TALZENNA?
Summary for TALZENNA
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 44 |
| Clinical Trials: | 23 |
| Patent Applications: | 363 |
| 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 Dates for TALZENNA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL |
Generic Entry Dates 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 |
| Hospital Sultan Ismail | Phase 2 |
| University of Malaya | Phase 2 |
Pharmacology for TALZENNA
| Drug Class | Poly(ADP-Ribose) Polymerase Inhibitor |
| Mechanism of Action | Poly(ADP-Ribose) Polymerase Inhibitors |
US Patents and Regulatory Information for TALZENNA
TALZENNA is protected by six US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TALZENNA is ⤷ Start Trial.
This potential generic entry date is based on patent ⤷ Start 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.
| 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 | 217439-006 | Mar 7, 2024 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Pfizer | TALZENNA | talazoparib tosylate | CAPSULE;ORAL | 211651-003 | Sep 20, 2021 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Pfizer | TALZENNA | talazoparib tosylate | CAPSULE;ORAL | 211651-006 | Jun 20, 2023 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Pfizer | TALZENNA | talazoparib tosylate | CAPSULE;ORAL | 217439-004 | Mar 7, 2024 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Pfizer | TALZENNA | talazoparib tosylate | CAPSULE;ORAL | 217439-005 | Mar 7, 2024 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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: 2970
Patent: DERIVADOS DEDIHIDROPIRIDOFTALAZINONA, COMPOSICIONES FARMACEUTICAS QUE LOS COMPRENDEN Y USO DE LOS MISMOS EN EL TRATAMIENTO Y/O PREVENCION DE ENFERMEDADES ASOCIADAS CON LA ENZIMA POLI(ADP RIBOSA) POLIMERASA(PARP), TALES COMO CANCER Y ENFERMEDADES VASCULARES, ENTRE OTRAS.
Estimated Expiration: ⤷ Start Trial
Australia
Patent: 09279944
Patent: Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)
Estimated Expiration: ⤷ Start Trial
Brazil
Patent: 0917119
Patent: composto, composição farmacêutica, métodos para inibir a poli(adp-ribose) polimerase em um paciente, para tratar uma doença, uso de um composto, e, artigo de fabricação.
Estimated Expiration: ⤷ Start Trial
Canada
Patent: 32797
Patent: INHIBITEURS DE POLY(ADP-RIBOSE)POLYMERASE (PARP) DE TYPE DIHYDROPYRIDOPHTALAZINONE (DIHYDROPYRIDOPHTHALAZINONE INHIBITORS OF POLY(ADP-RIBOSE)POLYMERASE (PARP))
Estimated Expiration: ⤷ Start Trial
China
Patent: 2171214
Patent: Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)
Estimated Expiration: ⤷ Start Trial
Patent: 3896942
Patent: Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)
Estimated Expiration: ⤷ Start Trial
Patent: 4478875
Patent: Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)
Estimated Expiration: ⤷ Start Trial
Croatia
Patent: 0170982
Estimated Expiration: ⤷ Start Trial
Cyprus
Patent: 15022
Estimated Expiration: ⤷ Start Trial
Patent: 19218
Estimated Expiration: ⤷ Start Trial
Patent: 19044
Estimated Expiration: ⤷ Start Trial
Denmark
Patent: 26650
Estimated Expiration: ⤷ Start Trial
Patent: 67537
Estimated Expiration: ⤷ Start Trial
European Patent Office
Patent: 26650
Patent: INHIBITEURS DE POLY(ADP-RIBOSE)POLYMÉRASE (PARP) DE TYPE DIHYDROPYRIDOPHTALAZINONE (DIHYDROPYRIDOPHTHALAZINONE INHIBITORS OF POLY(ADP-RIBOSE)POLYMERASE (PARP))
Estimated Expiration: ⤷ Start Trial
Patent: 67537
Patent: Inhibiteurs de type dihydropyridophthalazinone de poly(ADP-ribose)polymérase (PARP) (Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP))
Estimated Expiration: ⤷ Start Trial
Patent: 41832
Patent: INHIBITEURS DIHYDROPYRIDOPHTHALAZINONE DE POLY (ADP-RIBOSE) POLYMÉRASE (PARP) (DIHYDROPYRIDOPHTHALAZINONE INHIBITORS OF POLY(ADP-RIBOSE)POLYMERASE (PARP))
Estimated Expiration: ⤷ Start Trial
France
Patent: C1071
Estimated Expiration: ⤷ Start Trial
Hong Kong
Patent: 57755
Estimated Expiration: ⤷ Start Trial
Patent: 00813
Estimated Expiration: ⤷ Start Trial
Hungary
Patent: 35295
Estimated Expiration: ⤷ Start Trial
Patent: 900053
Estimated Expiration: ⤷ Start Trial
Israel
Patent: 1070
Patent: דיהידרופירידופתאלאזינון כמעקב של פולי (adp-ריבוז)פולימראז (Dihydropyridophthalazinone inhibitors of poly(adp-ribose)polymerase)
Estimated Expiration: ⤷ Start Trial
Japan
Patent: 84389
Estimated Expiration: ⤷ Start Trial
Patent: 11530513
Estimated Expiration: ⤷ Start Trial
Patent: 15157843
Patent: ポリ（ＡＤＰ−リボース）ポリメラーゼ（ＰＡＲＰ）のジヒドロピリドフタラジノン阻害剤 (DIHYDROPYRIDOPHTHALAZINONE INHIBITORS OF POLY(ADP-RIBOSE)POLYMERASE (PARP))
Estimated Expiration: ⤷ Start Trial
Patent: 18012698
Patent: ポリ（ＡＤＰ−リボース）ポリメラーゼ（ＰＡＲＰ）のジヒドロピリドフタラジノン阻害剤 (DIHYDROPYRIDOPHTHALAZINONE INHIBITORS OF POLY(ADP-RIBOSE)POLYMERASE (PARP))
Estimated Expiration: ⤷ Start Trial
Lithuania
Patent: 67537
Estimated Expiration: ⤷ Start Trial
Patent: 767537
Estimated Expiration: ⤷ Start Trial
Patent: 2019522
Estimated Expiration: ⤷ Start Trial
Luxembourg
Patent: 0140
Estimated Expiration: ⤷ Start Trial
Mexico
Patent: 11001328
Estimated Expiration: ⤷ Start Trial
New Zealand
Patent: 1166
Estimated Expiration: ⤷ Start Trial
Norway
Patent: 19042
Estimated Expiration: ⤷ Start Trial
Poland
Patent: 26650
Estimated Expiration: ⤷ Start Trial
Patent: 67537
Estimated Expiration: ⤷ Start Trial
Portugal
Patent: 26650
Estimated Expiration: ⤷ Start Trial
Patent: 67537
Estimated Expiration: ⤷ Start Trial
Russian Federation
Patent: 14937
Estimated Expiration: ⤷ Start Trial
Patent: 11108493
Estimated Expiration: ⤷ Start Trial
San Marino
Patent: 01700312
Estimated Expiration: ⤷ Start Trial
Singapore
Patent: 201809895Y
Estimated Expiration: ⤷ Start Trial
Patent: 3842
Estimated Expiration: ⤷ Start Trial
Slovenia
Patent: 26650
Estimated Expiration: ⤷ Start Trial
Patent: 67537
Estimated Expiration: ⤷ Start Trial
South Africa
Patent: 1100897
Estimated Expiration: ⤷ Start Trial
South Korea
Patent: 1846029
Estimated Expiration: ⤷ Start Trial
Patent: 110040973
Patent: DIHYDROPYRIDOPHTHALAZINONE INHIBITORS OF POLY(ADP-RIBOSE)POLYMERASE (PARP)
Estimated Expiration: ⤷ Start Trial
Spain
Patent: 66565
Estimated Expiration: ⤷ Start Trial
Patent: 25817
Estimated Expiration: ⤷ Start Trial
Taiwan
Patent: 1018688
Estimated Expiration: ⤷ Start Trial
Patent: 1422617
Estimated Expiration: ⤷ Start Trial
Patent: 48464
Estimated Expiration: ⤷ Start Trial
United Kingdom
Patent: 13474
Estimated Expiration: ⤷ Start Trial
Patent: 62361
Patent: Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP) activity
Estimated Expiration: ⤷ Start 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 |
|---|---|---|---|
| Argentina | 083502 | ⤷ Start Trial | |
| Australia | 2011317040 | ⤷ Start Trial | |
| Australia | 2017201564 | ⤷ Start Trial | |
| Brazil | 112013009117 | ⤷ Start Trial | |
| Canada | 2814581 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TALZENNA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 2767537 | PA2019522 | Lithuania | ⤷ Start Trial | PRODUCT NAME: TALAZOPARIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALU; REGISTRATION NO/DATE: EU/1/19/1377 20190620 |
| 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 | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.
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