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Generic Exkivity Availability

Last updated on Nov 8, 2022.

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

EXKIVITY (mobocertinib succinate - capsule;oral)

  • Manufacturer: TAKEDA PHARMS USA
    Approval date: September 15, 2021
    Strength(s): EQ 40MG BASE [RLD]

Has a generic version of Exkivity been approved?

No. There is currently no therapeutically equivalent version of Exkivity available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Exkivity. 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.

  • Heteroaryl compounds for kinase inhibition
    Patent 10,227,342
    Issued: March 12, 2019
    Assignee(s): ARIAD PHARMACEUTICALS, INC.

    Compounds and pharmaceutical compositions that modulate kinase activity, including mutant EGFR and mutant HER2 kinase activity, and compounds, pharmaceutical compositions, and methods of treatment of diseases and conditions associated with kinase activity, including mutant EGFR and mutant HER2 activity, are described herein.

    Patent expiration dates:

    • May 13, 2035
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      Patent use: TREATMENT OF PATIENTS WITH NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 20 EXON INSERTION MUTATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER PLATINUM-BASED CHEMOTHERAPY
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Heteroaryl compounds for kinase inhibition
    Patent 9,796,712
    Issued: October 24, 2017
    Assignee(s): ARIAD Pharmaceuticals, Inc.

    Compounds and pharmaceutical compositions that modulate kinase activity, including mutant EGFR and mutant HER2 kinase activity, and compounds, pharmaceutical compositions, and methods of treatment of diseases and conditions associated with kinase activity, including mutant EGFR and mutant HER2 activity, are described herein.

    Patent expiration dates:

    • May 13, 2035
      ✓ 
      Drug substance
      ✓ 
      Drug product

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:

    • September 15, 2026 - NEW CHEMICAL ENTITY
    • September 15, 2028 - TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 20 INSERTION MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST, WHOSE DISEASE HAS PROGRESSED ON OR AFTER PLAT

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.