Generic Vagifem Availability
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.
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
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✓
- July 1, 2017
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✓
- September 17, 2022
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:
- November 25, 2012 - USE OF VAGIFEM 10 MCG FOR THE TREATMENT OF ATROPHIC VAGINITIS DUE TO MENOPAUSE
- Vagifem local Consumer Information (Cerner Multum)
- Estradiol cream Consumer Information (Wolters Kluwer)
- Estradiol topical Consumer Information (Cerner Multum)
- Estradiol vaginal local Consumer Information (Cerner Multum)
|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.|