Talzenna Patent Expiration

Talzenna is a drug owned by Pfizer Inc. It is protected by 6 US drug patents filed from 2018 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 20, 2031. Details of Talzenna's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US10189837 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
Oct, 2031

(7 years from now)

Active
US8735392 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
Oct, 2031

(7 years from now)

Active
US8012976 Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)
Oct, 2029

(5 years from now)

Active
US8420650 Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)
Jul, 2029

(4 years from now)

Active
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9820985 Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)
Jul, 2029

(4 years from now)

Active
US10780088 Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)
Jul, 2029

(4 years from now)

Active


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Talzenna's patents.

Given below is the list of recent legal activities going on the following patents of Talzenna.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 08 Feb, 2024 US10780088
Second letter to regulating agency to determine regulatory review period 04 Dec, 2023 US8012976
Payment of Maintenance Fee, 12th Year, Large Entity 08 Feb, 2023 US8012976
Payment of Maintenance Fee, 4th Year, Large Entity 08 Jun, 2022 US10189837
Payment of Maintenance Fee, 8th Year, Large Entity 14 Oct, 2021 US8735392
Payment of Maintenance Fee, 4th Year, Large Entity 15 Apr, 2021 US9820985
Recordation of Patent Grant Mailed 22 Sep, 2020 US10780088
Patent Issue Date Used in PTA Calculation 22 Sep, 2020 US10780088
Payment of Maintenance Fee, 8th Year, Large Entity 15 Sep, 2020 US8420650
Email Notification 03 Sep, 2020 US10780088


FDA has granted several exclusivities to Talzenna. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Talzenna, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Talzenna.

Exclusivity Information

Talzenna holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Talzenna's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Oct 16, 2023
New Indication(I-920) Jun 20, 2026

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US patents provide insights into the exclusivity only within the United States, but Talzenna is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Talzenna's family patents as well as insights into ongoing legal events on those patents.

Talzenna's Family Patents

Talzenna has patent protection in a total of 30 countries. It's US patent count contributes only to 16.8% of its total global patent coverage. 2 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Talzenna.

Family Patents

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Generic Launch

Generic Release Date:

Talzenna's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 20, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Talzenna Generics:

There are no approved generic versions for Talzenna as of now.





About Talzenna

Talzenna is a drug owned by Pfizer Inc. It is used for treating advanced breast cancer and metastatic prostate cancer with specific gene mutations. Talzenna uses Talazoparib Tosylate as an active ingredient. Talzenna was launched by Pfizer in 2024.

Approval Date:

Talzenna was approved by FDA for market use on 07 March, 2024.

Active Ingredient:

Talzenna uses Talazoparib Tosylate as the active ingredient. Check out other Drugs and Companies using Talazoparib Tosylate ingredient

Treatment:

Talzenna is used for treating advanced breast cancer and metastatic prostate cancer with specific gene mutations.

Dosage:

Talzenna is available in capsule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 0.25MG BASE CAPSULE Prescription ORAL
EQ 0.1MG BASE CAPSULE Prescription ORAL
EQ 1MG BASE CAPSULE Prescription ORAL
EQ 0.5MG BASE CAPSULE Prescription ORAL
EQ 0.75MG BASE CAPSULE Prescription ORAL
EQ 0.35MG BASE CAPSULE Prescription ORAL


Talzenna News

European Commission Approves Pfizer's Latest Development

11 Jan, 2024

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