Generic Tirosint Availability
TIROSINT (levothyroxine sodium - capsule;oral)
Manufacturer: INST BIOCHIMIQUE
Approval date: August 1, 2007
Manufacturer: INSTITUT BIOCHIMIQUE
Approval date: October 13, 2006
Strength(s): 0.025MG, 0.05MG, 0.075MG, 0.1MG, 0.125MG, 0.15MG [RLD]
Manufacturer: INSTITUT BIOCHIMIQUE
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.
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 formulations for thyroid hormones
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✓
- March 14, 2024
- Tirosint Consumer Information (Wolters Kluwer)
- Tirosint Consumer Information (Cerner Multum)
- Tirosint Advanced Consumer Information (Micromedex)
- Levothyroxine Consumer Information (Drugs.com)
- Levothyroxine Consumer Information (Wolters Kluwer)
- Levothyroxine capsules Consumer Information (Wolters Kluwer)
- Levothyroxine solution Consumer Information (Wolters Kluwer)
- Levothyroxine Consumer Information (Cerner Multum)
- Levothyroxine Advanced Consumer Information (Micromedex)
- Levothyroxine Injection Advanced Consumer Information (Micromedex)
- Levothyroxine Sodium AHFS DI Monographs (ASHP)
|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.|