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Generic Tirosint Availability

Last updated on Nov 8, 2022.

See also: Generic Tirosint-Sol

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

TIROSINT (levothyroxine sodium - capsule;oral)

  • Manufacturer: INSTITUT BIOCHIMIQUE
    Approval date: October 13, 2006
    Strength(s): 0.025MG [RLD], 0.05MG [RLD], 0.075MG [RLD], 0.1MG [RLD], 0.125MG [RLD], 0.15MG [RLD]
  • Manufacturer: INSTITUT BIOCHIMIQUE
    Approval date: August 1, 2007
    Strength(s): 0.013MG [RLD]
  • Manufacturer: INSTITUT BIOCHIMIQUE
    Approval date: October 2, 2009
    Strength(s): 0.088MG [RLD], 0.112MG [RLD], 0.137MG [RLD]
  • Manufacturer: INSTITUT BIOCHIMIQUE
    Approval date: April 25, 2017
    Strength(s): 0.200MG [RLD], 0.175MG [RLD]
  • Manufacturer: INSTITUT BIOCHIMIQUE
    Approval date: June 22, 2022
    Strength(s): 0.0375MG [RLD], 0.044MG [RLD], 0.0625MG [RLD]

Has a generic version of Tirosint been approved?

An Authorized Generic version of Tirosint has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance and has exactly the same inactive ingredients.

List of authorized generic versions:

  • levothyroxine sodium ORAL CAPSULE 13 ug
    Lannett Company, Inc.
    NDC Code: 005274951
  • levothyroxine sodium ORAL CAPSULE 25 ug
    Lannett Company, Inc.
    NDC Code: 005274952
  • levothyroxine sodium ORAL CAPSULE 50 ug
    Lannett Company, Inc.
    NDC Code: 005274953
  • levothyroxine sodium ORAL CAPSULE 75 ug
    Lannett Company, Inc.
    NDC Code: 005274954
  • levothyroxine sodium ORAL CAPSULE 88 ug
    Lannett Company, Inc.
    NDC Code: 005274955
  • levothyroxine sodium ORAL CAPSULE 100 ug
    Lannett Company, Inc.
    NDC Code: 005274956
  • levothyroxine sodium ORAL CAPSULE 112 ug
    Lannett Company, Inc.
    NDC Code: 005274957
  • levothyroxine sodium ORAL CAPSULE 125 ug
    Lannett Company, Inc.
    NDC Code: 005274958
  • levothyroxine sodium ORAL CAPSULE 137 ug
    Lannett Company, Inc.
    NDC Code: 005274959
  • levothyroxine sodium ORAL CAPSULE 150 ug
    Lannett Company, Inc.
    NDC Code: 005274960
  • levothyroxine sodium ORAL CAPSULE 175 ug
    Lannett Company, Inc.
    NDC Code: 005274961
  • levothyroxine sodium ORAL CAPSULE 200 ug
    Lannett Company, Inc.
    NDC Code: 005274962
  • levothyroxine sodium ORAL CAPSULE 13 ug
    YARAL Pharma Inc.
    NDC Code: 823470005
  • levothyroxine sodium ORAL CAPSULE 25 ug
    YARAL Pharma Inc.
    NDC Code: 823470010
  • levothyroxine sodium ORAL CAPSULE 50 ug
    YARAL Pharma Inc.
    NDC Code: 823470015
  • levothyroxine sodium ORAL CAPSULE 75 ug
    YARAL Pharma Inc.
    NDC Code: 823470020
  • levothyroxine sodium ORAL CAPSULE 88 ug
    YARAL Pharma Inc.
    NDC Code: 823470025
  • levothyroxine sodium ORAL CAPSULE 100 ug
    YARAL Pharma Inc.
    NDC Code: 823470030
  • levothyroxine sodium ORAL CAPSULE 112 ug
    YARAL Pharma Inc.
    NDC Code: 823470035
  • levothyroxine sodium ORAL CAPSULE 125 ug
    YARAL Pharma Inc.
    NDC Code: 823470040
  • levothyroxine sodium ORAL CAPSULE 137 ug
    YARAL Pharma Inc.
    NDC Code: 823470045
  • levothyroxine sodium ORAL CAPSULE 150 ug
    YARAL Pharma Inc.
    NDC Code: 823470050
  • levothyroxine sodium ORAL CAPSULE 175 ug
    YARAL Pharma Inc.
    NDC Code: 823470055
  • levothyroxine sodium ORAL CAPSULE 200 ug
    YARAL Pharma Inc.
    NDC Code: 823470060

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: Generic Drug FAQ.

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

Glossary

Term Definition
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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.