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Generic Tepmetko Availability

Last updated on Nov 7, 2023.

Tepmetko is a brand name of tepotinib, approved by the FDA in the following formulation(s):

TEPMETKO (tepotinib hydrochloride - tablet;oral)

  • 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.

  • Pyrimidinyl pyridazinone derivatives
    Patent 8,329,692
    Issued: December 11, 2012
    Assignee(s): Merck Patent Gesellschaft mit beschrankter Haftung

    Compounds 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
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      Drug substance
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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 GmbH

    Compounds 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
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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 GmbH

    Compounds 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
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      Patent use: TREATING A SOLID TUMOR, INCLUDING LUNG CANCER, WITH A MET ALTERATION(S), OR STABILIZING OR IMPROVING SYMPTOMS ASSOCIATED WITH HAVING A SOLID TUMOR, INCLUDING LUNG CANCER, WITH A MET ALTERATION(S), BY ADMINISTERING AN EFFECTIVE AMOUNT OF TEPOTINIB
  • Pyridazinone derivatives
    Patent 8,921,357
    Issued: December 30, 2014
    Inventor(s): Dorsch Dieter & Stieber Frank & Schadt Oliver & Blaukat Andree
    Assignee(s): Merck Patent GmbH

    Compounds 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
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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 GmbH

    Compounds 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
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      Patent use: TREATING A SOLID TUMOR, INCLUDING LUNG CANCER, HAVING A MET KINASE ALTERATION(S) BY ADMINISTERING AN EFFECTIVE AMOUNT OF TEPOTINIB
  • 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 GmbH

    Compounds 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
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      Drug product
  • Pyridazinone derivatives
    Patent 9,284,300
    Issued: March 15, 2016
    Inventor(s): Dorsch Dieter & Stieber Frank & Schadt Oliver & Blaukat Andree
    Assignee(s): Merck Patent GmbH

    Compounds of formula (I)

    Patent expiration dates:

    • April 29, 2028
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      Drug product
  • 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 GMBH

    Compounds 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
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      Patent use: TREATING A SOLID TUMOR, INCLUDING LUNG CANCER, WITH A MET ALTERATION(S), OR STABILIZING OR IMPROVING SYMPTOMS ASSOCIATED WITH HAVING A SOLID TUMOR, INCLUDING LUNG CANCER, WITH A MET ALTERATION(S), BY ADMINISTERING AN EFFECTIVE AMOUNT OF TEPOTINIB

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

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.

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