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. Talzenna's patents have been open to challenges since 16 October, 2022. 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. | |||
| 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
(6 years from now) | Active |
| 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
(6 years from now) | Active |
| US8012976 | Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP) |
Oct, 2029
(4 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.
Latest 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 |
|---|---|---|
 | ||
| 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 Critical | 22 Sep, 2020 | US10780088 |
| Patent Issue Date Used in PTA Calculation Critical | 22 Sep, 2020 | US10780088 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 15 Sep, 2020 | US8420650 |
| Email Notification Critical | 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 |
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
Explore Our Curated Drug Screens
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 2023.
Approval Date:
Talzenna was approved by FDA for market use on 20 June, 2023.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Talzenna is 20 June, 2023, its NCE-1 date is estimated to be 16 October, 2022.
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 0.35MG BASE | CAPSULE | Prescription | ORAL |
| EQ 1MG BASE | CAPSULE | Prescription | ORAL |
| EQ 0.5MG BASE | CAPSULE | Prescription | ORAL |
| EQ 0.25MG BASE | CAPSULE | Prescription | ORAL |
| EQ 0.75MG BASE | CAPSULE | Prescription | ORAL |
| EQ 0.1MG BASE | CAPSULE | Prescription | ORAL |