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Generic Femtrace Availability

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

FEMTRACE (estradiol acetate - tablet;oral)

  • Manufacturer: APIL
    Approval date: August 20, 2004
    Strength(s): 0.45MG, 0.9MG, 1.8MG [RLD]

Has a generic version of Femtrace been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Femtrace. 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: About generic drugs.

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.

  • Oral pharmaceutical products containing 17 β-estradiol-3-lower alkanoate, method of administering the same and process of preparation
    Patent 6,962,908
    Issued: November 8, 2005
    Inventor(s): Aloba; Oluwole T. & deVries; Tina M.
    Assignee(s): Warner Chilcott Company Inc.
    A pharmaceutical dosage unit for oral administration to a human female comprising a therapeutically effective amount of 17β-estradiol-3-lower alkanoate, most preferably 17β-estradiol-3-acetate, and a pharmaceutically acceptable carrier is disclosed. Also disclosed is a method for treating a human female in need of 17β-estradiol and a contraceptive method by oral administration of the pharmaceutical dosage unit and a method of preparing a pharmaceutical composition that may be used to form the pharmaceutical dosage unit of the invention.
    Patent expiration dates:
    • December 21, 2021
      ✓ 
      Drug product
  • Oral pharmaceutical products containing 17β-estradiol-3-lower alkanoate, method of administering the same and process of preparation
    Patent 7,572,779
    Issued: August 11, 2009
    Inventor(s): Aloba; Oluwole T. & deVries; Tina M
    Assignee(s): Warner Chilcott Company LLC
    A pharmaceutical dosage unit for oral administration to a human female comprising a therapeutically effective amount of 17β-estradiol-3-lower alkanoate, most preferably 17β-estradiol-3-acetate, and a pharmaceutically acceptable carrier is disclosed. Also disclosed is a method for treating a human female in need of 17β-estradiol and a contraceptive method by oral administration of the pharmaceutical dosage unit and a method of preparing a pharmaceutical composition that may be used to form the pharmaceutical dosage unit of the invention.
    Patent expiration dates:
    • October 2, 2025
      ✓ 
      Patent use: TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
  • Oral pharmaceutical products containing 17β-estradiol-3-lower alkanoate, method of administering the same and process of preparation
    Patent 7,799,771
    Issued: September 21, 2010
    Inventor(s): Aloba; Oluwole T. & deVries; Tina M.
    Assignee(s): Warner Chilcott Company, LLC.
    A pharmaceutical dosage unit for oral administration to a human female comprising a therapeutically effective amount of 17β-estradiol-3-lower alkanoate, most preferably 17β-estradiol-3-acetate, and a pharmaceutically acceptable carrier is disclosed. Also disclosed is a method for treating a human female in need of 17β-estradiol and a contraceptive method by oral administration of the pharmaceutical dosage unit and a method of preparing a pharmaceutical composition that may be used to form the pharmaceutical dosage unit of the invention.
    Patent expiration dates:
    • December 21, 2021
      ✓ 
      Drug product

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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