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Generic Annovera Availability

Last updated on Oct 6, 2021.

Annovera is a brand name of ethinyl estradiol/segesterone, approved by the FDA in the following formulation(s):

ANNOVERA (ethinyl estradiol; segesterone acetate - ring;vaginal)

  • Manufacturer: THERAPEUTICSMD INC
    Approval date: August 10, 2018
    Strength(s): 0.013MG/24HR;0.15MG/24HR [RLD]

Has a generic version of Annovera been approved?

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

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

  • Patent 10,632,066

    Patent expiration dates:

    • February 1, 2039
      ✓ 
      Patent use: METHOD OF CONTRACEPTION BY INSERTING A VAGINAL SYSTEM FOR UP TO 13 21/7-DAY (IN/OUT) CYCLES, WHEREIN EFFICACY REQUIRES THE SYSTEM CANNOT BE OUT OF THE VAGINA FOR MORE THAN 2 CUMULATIVE HOURS IN ANY SUCH CYCLE WITHOUT USING ALTERNATIVE CONTRACEPTION
    • February 1, 2039
      ✓ 
      Patent use: METHOD OF PREVENTING PREGNANCY BY INSERTING A VAGINAL SYSTEM CONTAINING 103 MG OF SEGESTERONE ACETATE AND 17.4 MG ETHINYL ESTRADIOL INTO A VAGINA FOR UP TO THIRTEEN 21/7-DAY (IN/OUT) CYCLES
  • Patent 10,765,628

    Patent expiration dates:

    • February 1, 2039
      ✓ 
      Patent use: METHOD OF PREVENTING PREGNANCY BY INSERTING A VAGINAL SYSTEM CONTAINING 103 MG OF SEGESTERONE ACETATE AND 17.4 MG ETHINYL ESTRADIOL INTO A VAGINA FOR UP TO THIRTEEN 21/7-DAY (IN/OUT) CYCLES
    • February 1, 2039
      ✓ 
      Patent use: METHOD OF CONTRACEPTION BY INSERTING A VAGINAL SYSTEM FOR UP TO 13 21/7-DAY (IN/OUT) CYCLES, WHEREIN EFFICACY REQUIRES THE SYSTEM CANNOT BE OUT OF THE VAGINA FOR MORE THAN 2 CUMULATIVE HOURS IN ANY SUCH CYCLE WITHOUT USING ALTERNATIVE CONTRACEPTION
  • Patent 10,780,047

    Patent expiration dates:

    • February 1, 2039
      ✓ 
      Patent use: METHOD OF CONTRACEPTION BY INSERTING A VAGINAL SYSTEM FOR UP TO 13 21/7-DAY (IN/OUT) CYCLES, WHEREIN EFFICACY REQUIRES THE SYSTEM CANNOT BE OUT OF THE VAGINA FOR MORE THAN 2 CUMULATIVE HOURS IN ANY SUCH CYCLE WITHOUT USING ALTERNATIVE CONTRACEPTION
    • February 1, 2039
      ✓ 
      Patent use: METHOD OF PREVENTING PREGNANCY BY INSERTING A VAGINAL SYSTEM CONTAINING 103 MG OF SEGESTERONE ACETATE AND 17.4 MG ETHINYL ESTRADIOL INTO A VAGINA FOR UP TO THIRTEEN 21/7-DAY (IN/OUT) CYCLES
  • Patent 10,918,649

    Patent expiration dates:

    • June 21, 2039
      ✓ 
      Drug product
  • Patent 10,925,882

    Patent expiration dates:

    • June 21, 2039
      ✓ 
      Drug product
  • Patent 10,940,157

    Patent expiration dates:

    • June 21, 2039
      ✓ 
      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:

    • August 10, 2023 - NEW CHEMICAL ENTITY

More about Annovera (ethinyl estradiol / segesterone)

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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.