Generic Tepmetko Availability
Last updated on Dec 12, 2024.
Tepmetko is a brand name of tepotinib, approved by the FDA in the following formulation(s):
TEPMETKO (tepotinib hydrochloride - tablet;oral)
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Manufacturer: EMD SERONO INC
Approval date: February 3, 2021
Strength(s): EQ 225MG BASE [RLD]
Has a generic version of Tepmetko been approved?
No. There is currently no therapeutically equivalent version of Tepmetko available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Tepmetko. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Pyrimidinyl pyridazinone derivatives
Patent 8,329,692
Issued: December 11, 2012
Assignee(s): Merck Patent Gesellschaft mit beschrankter HaftungCompounds selected from the group according to Claim are inhibitors of tyrosine kinases, in particular of Met kinase, and can be employed, inter alia, for the treatment of tumours.
Patent expiration dates:
- October 30, 2029✓✓
- October 30, 2029
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Pyridazinone derivatives
Patent 8,580,781
Issued: November 12, 2013
Inventor(s): Dorsch Dieter & Stieber Frank & Schadt Oliver & Blaukat Andree
Assignee(s): Merck Patent GmbHCompounds of the formula (I), in which R, R, R, R, R have the meanings indicated in claim 1, are inhibitors of tyrosine kinases, in particular Met kinase, and can be employed, inter alia, for the treatment of tumors.
Patent expiration dates:
- March 19, 2030✓✓
- March 19, 2030
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Pyrimidinyl pyridazinone derivatives
Patent 8,658,643
Issued: February 25, 2014
Inventor(s): Schadt Oliver & Dorsch Dieter & Stieber Frank & Blaukat Andree
Assignee(s): Merck Patent GmbHCompounds selected from the group according to claim are inhibitors of tyrosine kinases, in particular of Met kinase, and can be employed, inter alia, for the treatment of tumours.
Patent expiration dates:
- July 4, 2028✓
- July 4, 2028
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Pyridazinone derivatives
Patent 8,921,357
Issued: December 30, 2014
Inventor(s): Dorsch Dieter & Stieber Frank & Schadt Oliver & Blaukat Andree
Assignee(s): Merck Patent GmbHCompounds of the formula (I), in which R, R, R, R, R′ have the meanings indicated in Claim , are inhibitors of tyrosine kinases, in particular Met kinase, and can be employed, inter alia, for the treatment of tumors.
Patent expiration dates:
- May 30, 2028✓✓
- May 30, 2028
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Pyridazinone derivatives
Patent 8,927,540
Issued: January 6, 2015
Inventor(s): Dorsch Dieter & Stieber Frank & Schadt Oliver & Blaukat Andree
Assignee(s): Merck Patent GmbHCompounds of the formula (I), in which R, R, R, R, R, have the meanings indicated in Claim , are inhibitors of tyrosine kinases, in particular Met kinase, and can be employed, inter alia, for the treatment of tumors.
Patent expiration dates:
- July 21, 2028✓
- July 21, 2028
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Pyrimidinyl pyridazinone derivatives
Patent 9,062,029
Issued: June 23, 2015
Inventor(s): Schadt Oliver & Dorsch Dieter & Stieber Frank & Blaukat Andree
Assignee(s): Merck Patent GmbHCompounds selected from the group according to Claim are inhibitors of tyrosine kinases, in particular of Met kinase, and can be employed, inter alia, for the treatment of tumours.
Patent expiration dates:
- July 4, 2028✓
- July 4, 2028
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Pyridazinone derivatives
Patent 9,284,300
Issued: March 15, 2016
Inventor(s): Dorsch Dieter & Stieber Frank & Schadt Oliver & Blaukat Andree
Assignee(s): Merck Patent GmbHCompounds of formula (I)
Patent expiration dates:
- April 29, 2028✓
- April 29, 2028
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Pyrimidinyl-pyridazinone derivatives for treating a disease which is influenced by inhibition of met kinase
Patent 9,403,799
Issued: August 2, 2016
Inventor(s): Schadt Oliver & Dorsch Dieter & Stieber Frank & Blaukat Andree
Assignee(s): MERCK PATENT GMBHCompounds selected from the group according to claim are inhibitors of tyrosine kinases, in particular of Met kinase, and can be employed, inter alia, for the treatment of tumors.
Patent expiration dates:
- July 4, 2028✓
- July 4, 2028
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- February 3, 2026 - NEW CHEMICAL ENTITY
- February 3, 2028 - TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING ALTERATIONS
More about Tepmetko (tepotinib)
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
