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Generic Tembexa Availability

Last updated on Jul 6, 2022.

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

TEMBEXA (brincidofovir - suspension;oral)

  • Manufacturer: CHIMERIX
    Approval date: June 4, 2021
    Strength(s): 10MG/ML [RLD]

TEMBEXA (brincidofovir - tablet;oral)

  • Manufacturer: CHIMERIX
    Approval date: June 4, 2021
    Strength(s): 100MG [RLD]

Has a generic version of Tembexa been approved?

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

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

  • Morphic forms of hexadecyloxypropyl-phosphonate esters and methods of synthesis thereof
    Patent 10,112,909
    Issued: October 30, 2018
    Assignee(s): Chimerix, Inc.

    The disclosure describes methods of synthesis of phosphonate ester compounds. The methods according to the disclosure allow for large-scale preparation of phosphonate ester compounds having high purity and stability. Also disclosed are morphic forms of phosphonate ester compounds.

    Patent expiration dates:

    • October 10, 2034
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      Patent use: METHOD OF TREATING HUMAN SMALLPOX DISEASE
  • Patent 10,487,061

    Patent expiration dates:

    • October 10, 2034
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      Patent use: METHOD OF TREATING HUMAN SMALLPOX DISEASE
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      Drug product
  • Morphic forms of hexadecyloxypropyl-phosphonate esters and methods of synthesis thereof
    Patent 8,962,829
    Issued: February 24, 2015
    Assignee(s): Chimerix, Inc.

    The disclosure describes methods of synthesis of phosphonate ester compounds. The methods according to the disclosure allow for large-scale preparation of phosphonate ester compounds having high purity and stability. Also disclosed are morphic forms of phosphonate ester compounds.

    Patent expiration dates:

    • October 10, 2034
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      Drug substance
      ✓ 
      Drug product
  • Phosphonate ester derivatives and methods of synthesis thereof
    Patent 9,303,051
    Issued: April 5, 2016
    Assignee(s): Chimerix Inc.

    The disclosure describes methods of synthesis of phosphonate ester derivatives. Preferred methods according to the disclosure allow for large-scale preparation of phosphonate ester compounds having high purity. In some embodiments, preferred methods according to the disclosure also allow for the preparation of phosphonate ester derivatives without the use of chromatographic purification methods and in better yield than previously used methods for preparing such compounds. Also disclosed are morphic forms of phosphonate ester derivatives.

    Patent expiration dates:

    • August 31, 2031
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      Patent use: METHOD OF TREATING HUMAN SMALLPOX DISEASE
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      Drug substance
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      Drug product
  • Morphic forms of hexadecyloxypropyl-phosphonate esters and methods of synthesis thereof
    Patent 9,371,344
    Issued: June 21, 2016
    Assignee(s): Chimerix, Inc.

    The disclosure describes methods of synthesis of phosphonate ester compounds. The methods according to the disclosure allow for large-scale preparation of phosphonate ester compounds having high purity and stability. Also disclosed are morphic forms of phosphonate ester compounds.

    Patent expiration dates:

    • October 10, 2034
      ✓ 
      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:

    • June 4, 2024 - NEW PRODUCT
    • June 4, 2028 - TREATMENT OF HUMAN SMALLPOX DISEASE CAUSED BY VARIOLA VIRUS IN ADULT AND PEDIATRIC PATIENTS, INCLUDING NEONATES

More about Tembexa (brincidofovir)

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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.