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Generic TPOXX Availability

Last updated on Oct 6, 2021.

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

TPOXX (tecovirimat - capsule;oral)

  • Manufacturer: SIGA TECHNOLOGIES
    Approval date: July 13, 2018
    Strength(s): 200MG [RLD]

Has a generic version of TPOXX been approved?

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

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

  • Compounds, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases
    Patent 7,737,168
    Issued: June 15, 2010
    Inventor(s): Jordan; Robert & Bailey; Thomas R. & Rippin; Susan R.
    Assignee(s): Siga Technologies, Inc.

    Methods of using di, tri, and tetracyclic acylhydrazide derivatives and analogs, as well as pharmaceutical compositions containing the same, for the treatment or prophylaxis of viral infections and diseases associated therewith, particularly those viral infections and associated diseases cased by the orthopoxvirus.

    Patent expiration dates:

    • May 3, 2027
      ✓ 
      Patent use: TREATMENT OF HUMAN SMALLPOX DISEASE CAUSED BY VARIOLA VIRUS IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 13 KG
  • Chemicals, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases
    Patent 8,039,504
    Issued: October 18, 2011
    Inventor(s): Jordan; Robert F. & Bailey; Thomas R. & Rippin; Susan R. & Dai; Dongcheng
    Assignee(s): Siga Technologies, Inc.

    Methods of using di, tri, and tetracyclic acylhydrazide derivatives and analogs, as well as pharmaceutical compositions containing the same, for the treatment or prophylaxis of viral infections and diseases associated therewith, particularly those viral infections and associated diseases cased by the orthopoxvirus.

    Patent expiration dates:

    • July 23, 2027
      ✓ 
      Drug product
  • Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
    Patent 8,124,643
    Issued: February 28, 2012
    Inventor(s): Jordan; Robert & Bailey; Thomas R. & Rippin; Susan R.
    Assignee(s): Siga Technologies, Inc.

    Methods of using di, tri, and tetracyclic acylhydrazide derivatives and analogs, as well as pharmaceutical compositions containing the same, for the treatment or prophylaxis of viral infections and diseases associated therewith, particularly those viral infections and associated diseases caused by the orthopoxvirus.

    Patent expiration dates:

    • June 18, 2024
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
    Patent 8,530,509
    Issued: September 10, 2013
    Assignee(s): Siga Technologies, Inc.

    Methods of using di, tri, and tetracyclic acylhydrazide derivatives and analogs, as well as pharmaceutical compositions containing the same, for the treatment or prophylaxis of viral infections and diseases associated therewith, particularly those viral infections and associated diseases caused by the orthopoxvirus.

    Patent expiration dates:

    • June 18, 2024
      ✓ 
      Drug product
  • Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
    Patent 8,802,714
    Issued: August 12, 2014
    Assignee(s): Siga Technologies, Inc.

    Methods of using di, tri, and tetracyclic acylhydrazide derivatives and analogs, as well as pharmaceutical compositions containing the same, for the treatment or prophylaxis of viral infections and diseases associated therewith, particularly those viral infections and associated diseases caused by the orthopoxvirus.

    Patent expiration dates:

    • June 18, 2024
      ✓ 
      Patent use: TREATMENT OF HUMAN SMALLPOX DISEASE CAUSED BY VARIOLA VIRUS IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 13 KG
  • Polymorphic forms of ST-246 and methods of preparation
    Patent 9,339,466
    Issued: May 17, 2016
    Assignee(s): SIGA TECHNOLOGIES, INC.

    Polymorph forms of 4-trifluoromethyl-N-(3,3a,4,4a,5,5a,6,6a-octahydro-1,3-dioxo-4,6-ethenocycloprop[f]isoindol-2(1H)-yl)-benzamide are disclosed as well as their methods of synthesis and pharmaceutical compositions.

    Patent expiration dates:

    • March 23, 2031
      ✓ 
      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:

    • July 13, 2023 - NEW CHEMICAL ENTITY
    • July 13, 2025 -

More about TPOXX (tecovirimat)

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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.