Tabrecta is a drug owned by Novartis Pharmaceutical Corp. It is protected by 7 US drug patents filed from 2020 to 2025 out of which none have expired yet. Tabrecta's patents have been open to challenges since 06 May, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 22, 2035. Details of Tabrecta'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. | |||
| US7767675 | Imidazotriazines and imidazopyrimidines as kinase inhibitors |
Nov, 2032
(7 years from now) | Active |
| US8420645 | Salts of 2-fluoro-N-methyl-4-[7-(quinolin-6-yl-methyl)-imidazo[1,2-b][1,2,4]triazin-2-yl]benzamide and processes related to preparing the same |
Jun, 2031
(6 years from now) | Active |
| US8461330 | Imidazotriazines and imidazopyrimidines as kinase inhibitors |
Nov, 2027
(2 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). | |||
| US12208101 | Tablet formulation of 2-fluoro-n-methyl-4-[7-(quinolin-6-ylmethyl)imidazo[1,2-b][1,2,4]triazin-2-yl]benzamide |
Jul, 2035
(10 years from now) | Active |
| US10596178 | Tablet formulation of 2-fluoro-N-methyl-4-[7-(quinolin-6-ylmethyl) imidazo [1,2-B] [1,2,4] triazin-2-yl] benzamide |
Jul, 2035
(10 years from now) | Active |
| US8901123 | Salts of 2-fluoro-N-methyl-4-[7-(quinolin-6-yl-methyl)-imidazo[1,2-B][1,2,4]triazin-2-yl]benzamide and processes related to preparing the same |
May, 2029
(4 years from now) | Active |
| US12084449 | Imidazotriazines and imidazopyrimidines as kinase inhibitors |
Nov, 2027
(2 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 Tabrecta's patents.
Latest Legal Activities on Tabrecta's Patents
Given below is the list of recent legal activities going on the following patents of Tabrecta.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Notice of Final Determination -Election Required | 18 Apr, 2024 | US7767675 |
| Notice of Final Determination -Election Required | 18 Apr, 2024 | US8420645 |
| Resp. to req. for info. sent under 37 CFR 1.750 | 08 Dec, 2023 | US7767675 |
| Resp. to req. for info. sent under 37 CFR 1.750 | 08 Dec, 2023 | US8420645 |
| Email Notification Critical | 20 Nov, 2023 | US8461330 |
| Change in Power of Attorney (May Include Associate POA) Critical | 20 Nov, 2023 | US8901123 |
| Change in Power of Attorney (May Include Associate POA) Critical | 20 Nov, 2023 | US8461330 |
| Email Notification Critical | 20 Nov, 2023 | US8901123 |
| Email Notification Critical | 19 Sep, 2023 | US7767675 |
| Change in Power of Attorney (May Include Associate POA) Critical | 19 Sep, 2023 | US8420645 |
FDA has granted several exclusivities to Tabrecta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tabrecta, 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 Tabrecta.
Exclusivity Information
Tabrecta holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Tabrecta's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 06, 2025 |
| Orphan Drug Exclusivity(ODE-291) | May 06, 2027 |
Several oppositions have been filed on Tabrecta's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Tabrecta's generic, the next section provides detailed information on ongoing and past EP oppositions related to Tabrecta patents.
Tabrecta's Oppositions Filed in EPO
Tabrecta has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 18, 2018, by Generics (U.K.) Limited. This opposition was filed on patent number EP09751439A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP15744702A | Sep, 2021 | D Young & Co LLP | Granted and Under Opposition |
| EP09751439A | Apr, 2018 | Generics (U.K.) Limited | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Tabrecta 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 Tabrecta's family patents as well as insights into ongoing legal events on those patents.
Tabrecta's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tabrecta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 22, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tabrecta Generics:
There are no approved generic versions for Tabrecta as of now.
About Tabrecta
Tabrecta is a drug owned by Novartis Pharmaceutical Corp. It is used for treating patients with metastatic non-small cell lung cancer with a mesenchymal-epithelial transition exon 14 skipping mutation. Tabrecta uses Capmatinib Hydrochloride as an active ingredient. Tabrecta was launched by Novartis Pharm in 2020.
Approval Date:
Tabrecta was approved by FDA for market use on 06 May, 2020.
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 Tabrecta is 06 May, 2020, its NCE-1 date is estimated to be 06 May, 2024.
Active Ingredient:
Tabrecta uses Capmatinib Hydrochloride as the active ingredient. Check out other Drugs and Companies using Capmatinib Hydrochloride ingredient
Treatment:
Tabrecta is used for treating patients with metastatic non-small cell lung cancer with a mesenchymal-epithelial transition exon 14 skipping mutation.
Dosage:
Tabrecta is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 150MG BASE | TABLET | Prescription | ORAL |
| EQ 200MG BASE | TABLET | Prescription | ORAL |