Tepmetko is a drug owned by Emd Serono Inc. It is protected by 8 US drug patents filed in 2021 out of which none have expired yet. Tepmetko's patents have been open to challenges since 03 February, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 19, 2030. Details of Tepmetko'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. | |||
| US8580781 | Pyridazinone derivatives |
Mar, 2030
(4 years from now) | Active |
| US8329692 | Pyrimidinyl pyridazinone derivatives |
Oct, 2029
(4 years from now) | Active |
| US8921357 | Pyridazinone derivatives |
May, 2028
(3 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). | |||
| US8927540 | Pyridazinone derivatives |
Jul, 2028
(3 years from now) | Active |
| US8658643 | Pyrimidinyl pyridazinone derivatives |
Jul, 2028
(3 years from now) | Active |
| US9403799 | Pyrimidinyl-pyridazinone derivatives for treating a disease which is influenced by inhibition of met kinase |
Jul, 2028
(3 years from now) | Active |
| US9062029 | Pyrimidinyl pyridazinone derivatives |
Jul, 2028
(3 years from now) | Active |
| US9284300 | Pyridazinone derivatives |
Apr, 2028
(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 Tepmetko's patents.
Latest Legal Activities on Tepmetko's Patents
Given below is the list of recent legal activities going on the following patents of Tepmetko.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 29 May, 2024 | US8329692 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Jan, 2024 | US9403799 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Aug, 2023 | US9284300 |
| Second letter to regulating agency to determine regulatory review period | 27 Feb, 2023 | US8580781 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Dec, 2022 | US9062029 |
| Letter from FDA or Dept of Agriculture re PTE application | 21 Sep, 2022 | US8580781 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Jun, 2022 | US8927540 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 15 Jun, 2022 | US8921357 |
| Initial letter Re: PTE Application to regulating agency | 25 Feb, 2022 | US8580781 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 Aug, 2021 | US8658643 |
FDA has granted several exclusivities to Tepmetko. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tepmetko, 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 Tepmetko.
Exclusivity Information
Tepmetko holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Tepmetko's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 03, 2026 |
| Orphan Drug Exclusivity(ODE-325) | Feb 03, 2028 |
US patents provide insights into the exclusivity only within the United States, but Tepmetko 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 Tepmetko's family patents as well as insights into ongoing legal events on those patents.
Tepmetko's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tepmetko's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 19, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tepmetko Generics:
There are no approved generic versions for Tepmetko as of now.
About Tepmetko
Tepmetko is a drug owned by Emd Serono Inc. It is used for treating solid tumors with MET kinase alterations, including lung cancer, by administering Tepotinib. Tepmetko uses Tepotinib Hydrochloride as an active ingredient. Tepmetko was launched by Emd Serono Inc in 2021.
Approval Date:
Tepmetko was approved by FDA for market use on 03 February, 2021.
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 Tepmetko is 03 February, 2021, its NCE-1 date is estimated to be 03 February, 2025.
Active Ingredient:
Tepmetko uses Tepotinib Hydrochloride as the active ingredient. Check out other Drugs and Companies using Tepotinib Hydrochloride ingredient
Treatment:
Tepmetko is used for treating solid tumors with MET kinase alterations, including lung cancer, by administering Tepotinib.
Dosage:
Tepmetko is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 225MG BASE | TABLET | Prescription | ORAL |