Generic Vagifem Availability

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

VAGIFEM (estradiol - tablet;vaginal)

Has a generic version of Vagifem been approved?

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

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

  • Instrument for inserting a suppository
    Patent 5,860,946
    Issued: January 19, 1999
    Inventor(s): Hofstatter; Thibaud
    Assignee(s): Novo Nordisk A/S
    In an instrument for inserting a suppository, which instrument comprises a tubular housing (31) with a first end adapted to receive said suppository between two tongues (30) and a second end through which a plunger (22) is inserted in the tube, which plunger has a first end having a circular cross section and two axially spaced circumferential flanges (26, 27) and a second end projecting from the second end of the tube (31). The first end of the tube has an inwardly extending shoulder (25) which engage between said flanges (26, 27) and the first end of the piston is by radial slots divided into an uneven number of sectors (29). The plunger (22) has between its first end and a press button (24) at its second end angular spaced radial walls (21) abutting the inner wall of the tube (31) and axial spaced disc shaped walls are provided having a diameter corresponding to the inner diameter of the tube (31).
    Patent expiration dates:
    • July 1, 2017
      ✓ 
      Drug product
  • Hormone composition
    Patent 7,018,992
    Issued: March 28, 2006
    Inventor(s): Koch; Karen & Kvorning; Ingelise
    Assignee(s): Novo Nordisk A/S
    Twice weekly administration of an analog to a Vagifem tablet which only contains 10 μg of active material has a sufficient effect.
    Patent expiration dates:
    • September 17, 2022
      ✓ 
      Patent use: TREATMENT OF ATROPHIC VAGINITIS DUE TO MENOPAUSE

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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