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Generic Solosec Availability

Last updated on Nov 8, 2022.

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

SOLOSEC (secnidazole - granule;oral)

  • Manufacturer: LUPIN
    Approval date: September 15, 2017
    Strength(s): 2GM/PACKET [RLD]

Has a generic version of Solosec been approved?

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

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

  • Secnidazole for use in the treatment of bacterial vaginosis
    Patent 10,335,390
    Issued: July 2, 2019
    Assignee(s): Symbiomix Therapeutics, LLC

    Embodiments are directed to a secnidazole formulations and the use of a secnidazole formulation for the treatment of bacterial vaginosis (BV).

    Patent expiration dates:

    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN
      ✓ 
      Drug product
    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER
      ✓ 
      Drug product
  • Patent 10,682,338

    Patent expiration dates:

    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER
      ✓ 
      Drug product
    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN
      ✓ 
      Drug product
  • Patent 10,849,884

    Patent expiration dates:

    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER
      ✓ 
      Drug product
    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER
      ✓ 
      Drug product
    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF TRICHOMONIASIS IN ADULTS
      ✓ 
      Drug product
    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN
      ✓ 
      Drug product
  • Patent 10,857,133

    Patent expiration dates:

    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER
      ✓ 
      Drug product
    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN
      ✓ 
      Drug product
  • Patent 11,000,507

    Patent expiration dates:

    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER
      ✓ 
      Drug product
    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER
      ✓ 
      Drug product
    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF TRICHOMONIASIS IN ADULTS
      ✓ 
      Drug product
    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN
      ✓ 
      Drug product
  • Patent 11,000,508

    Patent expiration dates:

    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER
      ✓ 
      Drug product
    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER
      ✓ 
      Drug product
    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF TRICHOMONIASIS IN ADULTS
      ✓ 
      Drug product
    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN
      ✓ 
      Drug product
  • Patent 11,020,377

    Patent expiration dates:

    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER
      ✓ 
      Drug product
    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER
      ✓ 
      Drug product
    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF TRICHOMONIASIS IN ADULTS
      ✓ 
      Drug product
    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN
      ✓ 
      Drug product
  • Patent 11,324,721

    Patent expiration dates:

    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN
      ✓ 
      Drug product
    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF TRICHOMONIASIS IN ADULTS
      ✓ 
      Drug product
    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER
      ✓ 
      Drug product
    • September 4, 2035
      ✓ 
      Patent use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER
      ✓ 
      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, 2022 - NEW CHEMICAL ENTITY
    • June 30, 2024 - FOR THE TREATMENT OF TRICHOMONIASIS CAUSED BY TRICHOMONAS VAGINALIS IN ADULTS
    • January 26, 2025 - NEW PATIENT POPULATION
    • September 15, 2027 - GENERATING ANTIBIOTIC INCENTIVES NOW

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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