Generic Solosec Availability

Last updated on Jul 9, 2025.

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

SOLOSEC (secnidazole - granule;oral)

Manufacturer: EVOFEM INC
Approval date: September 15, 2017
Strength(s): 2GM/PACKET ^[RLD]

Is there a generic version of Solosec available?

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.

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
Inventor(s): Pentikis Helen S. & Palling David & Braun Carol J.
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
Secnidazole for use in the treatment of bacterial vaginosis
Patent 10,682,338
Issued: June 16, 2020
Inventor(s): Pentikis Helen S. & Palling David & Braun Carol J. & Holl Richard
Assignee(s): Lupin Inc.
Method of treating bacterial vaginosis in a subject in need thereof involving administering to the subject a therapeutically effective amount of secnidazole in a microgranule formulation, wherein the microgranule formulation comprises a plurality of microgranules having a volume-weighted particle size distribution within a microgranule population, wherein the volume-weighted particle size distribution as measured from a representative sample of the microgranule population comprises (a) 10% of the microgranule population having a volume-weighted particle size about no less than 470 micrometers; (b) 50% of the microgranule population having a volume-weighted particle size between about no less than 640 micrometers and about no more than 810 micrometers; (c) 90% of the microgranule population having a volume-weighted particle size about no more than 1170 micrometers; or (d) a combination thereof, which can include some or all of (a) through (c) above.
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
Secnidazole for use in the treatment of bacterial vaginosis
Patent 10,849,884
Issued: December 1, 2020
Inventor(s): Pentikis Helen S. & Palling David & Braun Carol J.
Assignee(s): LUPIN INC.
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 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
Secnidazole for use in the treatment of bacterial vaginosis
Patent 10,857,133
Issued: December 8, 2020
Inventor(s): Pentikis Helen S. & Palling David & Braun Carol J.
Assignee(s): LUPIN INC.
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
Secnidazole for use in the treatment of bacterial vaginosis
Patent 11,000,507
Issued: May 11, 2021
Inventor(s): Pentikis Helen S. & Palling David & Braun Carol J. & Holl Richard
Assignee(s): LUPIN INC.
Method of treating bacterial vaginosis in a subject in need thereof involving administering to the subject a therapeutically effective amount of secnidazole in a microgranule formulation, wherein the microgranule formulation comprises a plurality of microgranules having a volume-weighted particle size distribution within a microgranule population, wherein the volume-weighted particle size distribution as measured from a representative sample of the microgranule population comprises (a) at least 10% of the microgranule population having a volume-weighted particle size about no less than 470 micrometers; or (b) 50% of the microgranule population having a volume-weighted particle size between about no less than 640 micrometers and about no more than 810 micrometers; or (c) 90% of the microgranule population having a volume-weighted particle size about no more than 1170 micrometers; or (d) a combination thereof, which can include some or all of (a) through (c) above.
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
Secnidazole for use in the treatment of trichomoniasis
Patent 11,000,508
Issued: May 11, 2021
Inventor(s): Pentikis Helen S. & Palling David & Braun Carol J. & Holl Richard
Assignee(s): LUPIN INC.
Method of treating trichomoniasis in a subject in need thereof involving administering to the subject a therapeutically effective amount of secnidazole in a microgranule formulation, wherein the microgranule formulation comprises a plurality of microgranules having a volume-weighted particle size distribution within a microgranule population, wherein the volume-weighted particle size distribution as measured from a representative sample of the microgranule population comprises (a) at least 10% of the microgranule population having a volume-weighted particle size about no less than 470 micrometers; or (b) 50% of the microgranule population having a volume-weighted particle size between about no less than 640 micrometers and about no more than 810 micrometers; or (c) 90% of the microgranule population having a volume-weighted particle size about no more than 1170 micrometers; or (d) a combination thereof, which can include some or all of (a) through (c) above.
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
Secnidazole for use in the treatment of bacterial vaginosis
Patent 11,020,377
Issued: June 1, 2021
Inventor(s): Pentikis Helen S. & Palling David & Braun Carol J.
Assignee(s): LUPIN INC.
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 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
Secnidazole for use in the treatment of trichomoniasis
Patent 11,324,721
Issued: May 10, 2022
Inventor(s): Pentikis; Helen S. et al.
Assignee(s): Lupin Inc. (Baltimore, MD)
Embodiments are directed to secnidazole formulations and the use of a secnidazole formulation for the treatment of trichomoniasis in a subject in need thereof.
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
Secnidazole for use in the treatment of sexually transmitted infection
Patent 11,602,522
Issued: March 14, 2023
Inventor(s): Pentikis; Helen S. et al.
Assignee(s): LUPIN INC. (Baltimore, MD)
Method of treating sexually transmitted infection in a subject in need thereof involving administering to the subject a therapeutically effective amount of secnidazole in a microgranule formulation, wherein the microgranule formulation comprises a plurality of microgranules having a volume-weighted particle size distribution within a microgranule population, wherein the volume-weighted particle size distribution as measured from a representative sample of the microgranule population comprises (a) 10% of the microgranule population having a volume-weighted particle size about no less than 470 micrometers; (b) 50% of the microgranule population having a volume-weighted particle size between about no less than 640 micrometers and about no more than 810 micrometers; (c) 90% of the microgranule population having a volume-weighted particle size about no more than 1170 micrometers; or (d) a combination thereof, which can include some or all of (a) through (c) above. Pharmaceutical compositions and uses thereof are included herein.
Patent expiration dates:
- September 4, 2035
  ✓
  Patent use: TREATMENT OF TRICHOMONIASIS IN ADULTS
  ✓
  Drug product
- September 4, 2035
  ✓
  Patent use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER
  ✓
  Drug product
Secnidazole for use in the treatment of bacterial vaginosis
Patent 11,684,607
Issued: June 27, 2023
Inventor(s): Pentikis; Helen S. et al.
Assignee(s): LUPIN, INC. (Baltimore, MD)
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 16, 2035
  ✓
  Patent use: TREATMENT OF BACTERIAL VAGINOSIS IN ADULT WOMEN
  ✓
  Drug product
- September 16, 2035
  ✓
  Patent use: TREATMENT OF TRICHOMONIASIS IN ADULTS
  ✓
  Drug product
- September 16, 2035
  ✓
  Patent use: TREATMENT OF BACTERIAL VAGINOSIS IN FEMALE PATIENTS 12 YEARS OF AGE AND OLDER
  ✓
  Drug product
- September 16, 2035
  ✓
  Patent use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER
  ✓
  Drug product
Method and pharmaceutical composition for treating or preventing trichomoniasis and uses thereof
Patent 12,280,037
Issued: April 22, 2025
Inventor(s): Pentikis; Helen S. et al.
Assignee(s): EVOFEM BIOSCIENCES, INC. (San Diego, CA)
Method of treating or preventing trichomoniasis or T. vaginalis infection in a subject in need thereof, the method involving administering to the subject a therapeutically effective amount of secnidazole or a pharmaceutically acceptable salt in a microgranule formulation, wherein the microgranule formulation comprises a plurality of microgranules. The subject can also have bacterial vaginosis, is HIV-positive, and/or is suffering with metronidazole-resistant trichomoniasis and/or tinidazole-resistant trichomoniasis. The subject can also be a sexual partner of a person with trichomoniasis. The microgranule formulation can also be administered with paromomycin, tinidazole, metronidazole, boric acid or a combination thereof. Pharmaceutical compositions and uses for treating or preventing trichomoniasis or T. vaginalis infection in a subject in need thereof are also contemplated herein.
Patent expiration dates:
- December 11, 2041
  ✓
  Patent use: TREATMENT OF TRICHOMONIASIS IN PATIENTS 12 YEARS OF AGE AND OLDER

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
- January 26, 2025 - NEW PATIENT POPULATION
- September 15, 2027 - GENERATING ANTIBIOTIC INCENTIVES NOW

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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.

Medical Disclaimer

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

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