Generic Thyrogen Availability
THYROGEN (thyrotropin alfa - injectable;injection)
Has a generic version of Thyrogen been approved?
No. There is currently no therapeutically equivalent version of Thyrogen available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Thyrogen. 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.
Isolation of a gene encoding human thyrotropin beta subunit
Issued: November 24, 1998
Inventor(s): Kourides; Ione A. & Whitfield; Graham Kerr
Assignee(s): Sloan-Kettering Institute for Cancer Research
The gene expressing the beta subunit of human thyroid stimulating hormone has been isolated. The gene has been incorporated into plasmid pBR322. Vectors can be used to transform cells which in turn produce pure beta subunits. The beta subunits can then be combined with the alpha subunit of human glycoprotein hormones to produce pure thyroid stimulating hormone.Patent expiration dates:
- November 24, 2015
- November 24, 2015
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:
- December 14, 2014 - ORPHAN DRUG EXCLUSIVITY
- Thyrogen Consumer Information (Wolters Kluwer)
- Thyrogen Advanced Consumer Information (Micromedex)
- Thyrotropin alfa Consumer Information (Wolters Kluwer)
- Thytropar Advanced Consumer Information (Micromedex)
- Thyrotropin Injection Advanced Consumer Information (Micromedex)
- Thyrotropin alfa Injection Advanced Consumer Information (Micromedex)
|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.|