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Generic Tirosint Availability

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

TIROSINT (levothyroxine sodium - capsule;oral)

    Approval date: October 13, 2006
    Strength(s): 0.025MG, 0.05MG, 0.075MG, 0.1MG, 0.125MG, 0.15MG [RLD]
    Approval date: August 1, 2007
    Strength(s): 0.013MG
    Approval date: October 2, 2009
    Strength(s): 0.088MG, 0.112MG, 0.137MG

Has a generic version of Tirosint been approved?

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

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

  • Pharmaceutical formulae for thyroid hormones and procedures for obtaining them
    Patent 7,691,411
    Issued: April 6, 2010
    Inventor(s): Di Martino; Alessandro & Mateo; Angel & Garavani; Alberto & Marchiorri; Maurizio
    Assignee(s): Altergon S.A.
    The present invention provides pharmaceutical formulation for thyroid hormones which allow safe and stable administration by mouth within the ambit of the narrow therapeutic index prescribed in the case of thyroid dysfunctions, as well as procedures for obtaining them.
    Patent expiration dates:
    • March 14, 2024
      Drug product
  • Pharmaceutical formulations for thyroid hormones
    Patent 7,723,390
    Issued: May 25, 2010
    Inventor(s): Garavani; Alberto & Marchiorri; Maurizio & Di Martino; Alessandro & Mateo Echanagorria; Angel
    Assignee(s): Altergon S.A.
    The present invention provides for pharmaceutical formulations based on thyroid hormones enabling a safe and stable oral administration in the framework of the strict therapeutic index prescribed in case of thyroid disorders.
    Patent expiration dates:
    • March 14, 2024
      Drug product


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.