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Generic Balcoltra Availability

Last updated on Jan 11, 2023.

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

BALCOLTRA (ethinyl estradiol; levonorgestrel - tablet;oral)

  • Manufacturer: AVION PHARMS
    Approval date: January 9, 2018
    Strength(s): 0.02MG;0.1MG [RLD]

Has a generic version of Balcoltra been approved?

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

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

  • Hypoallergenic metal amino acid chelates and metal amino acid chelate-containing compositions
    Patent 7,838,042
    Issued: November 23, 2010
    Inventor(s): Motyka; Max R. & Harnish; Rick & Ashmead; Stephen D. & Ashmead; H. DeWayne
    Assignee(s): Albion International, Inc.

    Hypoallergenic metal amino acid chelate compositions, hypoallergenic formulations containing hypoallergenic metal amino acid chelates, methods of preparing hypoallergenic metal amino acid chelate, and methods of administering hypoallergenic metal amino acid chelates are provided. Specifically, the present invention provides metal amino acid chelates that are substantially free of allergens such that administration of the metal amino acid chelates to a subject in an effective amount to cause a medicinal or nutritional result does not produce a discernable adverse allergic reaction. The metal amino acid chelates can include chelates having a naturally occurring amino acid to metal molar ratio of from about 1:1 to 4:1.

    Patent expiration dates:

    • June 1, 2027
      Drug substance


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.