Generic Mirena Availability

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

MIRENA (levonorgestrel - intrauterine device;intrauterine)

  • Manufacturer: BAYER HLTHCARE
    Approval date: December 6, 2000
    Strength(s): 52MG [RLD]

Has a generic version of Mirena been approved?

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

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

  • Inserter for the positioning of an intrauterine device
    Patent 5,785,053
    Issued: July 28, 1998
    Inventor(s): Macandrew; John & Conway; John & Paton; Michael & Gardner; Richard & Rauramo; Ilkka & Lehtinen; Matti
    Assignee(s): Leiras Oy
    An inserter for the positioning of an intrauterine device in the uterus, which inserter includes a plunger, a handle attached to the plunger, a string for the removal of the IUD, a locking device to lock the string in such a way that the IUD remains immobile in relation to the plunger, and a protective tube around the plunger. The protective tube is arranged in relation to the plunger in such a way that it can be pushed, at the forward end that goes into the uterus, past the plunger at distance (L) , which corresponds substantially to the length of the IUD assembled for insertion. The stop members ensure that the front edge of the protective tube is stopped in a configuration in which the hemispherical tips of the wings of the transverse member of a T-shaped IUD remain partly uncovered by the protective tube, but the wings nevertheless remain pressed against each other.
    Patent expiration dates:
    • December 5, 2015
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      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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