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TALZENNA Drug Profile
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» See Plans and PricingWhen do Talzenna patents expire, and when can generic versions of Talzenna launch?
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-eight patent family members in twenty-eight 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
Summary for TALZENNA
| International Patents: | 78 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 47 |
| Clinical Trials: | 10 |
| Patent Applications: | 40 |
| Drug Prices: | Drug price information for TALZENNA |
| DailyMed Link: | TALZENNA at DailyMed |
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 |
|---|---|
| Ulrik Lassen | Phase 2 |
| GlaxoSmithKline | Phase 2 |
| Roche Pharma AG | 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
| 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 | ||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 101846029 | Start Trial |
| Israel | 271497 | Start Trial |
| Spain | 2466565 | Start Trial |
| Portugal | 2767537 | Start Trial |
| Australia | 2017201564 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TALZENNA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 1990055-4 | Sweden | Start Trial | PRODUCT NAME: TALAZOPARIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/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 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
