Generic Saizen Availability
SAIZEN (somatropin recombinant - injectable;injection)
Manufacturer: EMD SERONO
Approval date: August 29, 2000
Strength(s): 8.8MG/VIAL [RLD]
Has a generic version of Saizen been approved?
No. There is currently no therapeutically equivalent version of Saizen available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Saizen. 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.
hGH containing pharmaceutical compositions
Issued: April 27, 1999
Inventor(s): Samaritani; Fabrizio
Assignee(s): Applied Research Systems Ars Holding N.V
Pharmaceutical compositions containing hGH stabilized by means of saccharose. The formulation is particularly suitable for stabilizing a lyophilisate of recombinant hGH.Patent expiration dates:
- April 27, 2016✓
- April 27, 2016
- Saizen Consumer Information (Wolters Kluwer)
- Saizen Consumer Information (Cerner Multum)
- Saizen Subcutaneous, Injection Advanced Consumer Information (Micromedex®)
- Somatropin (rDNA origin - nonrefrigerated) Consumer Information (Wolters Kluwer)
- Somatropin (rDNA origin - refrigerated) Consumer Information (Wolters Kluwer)
- Somatropin (rDNA origin - refrigerated) cartridge Consumer Information (Wolters Kluwer)
- Somatropin (rDNA origin - refrigerated) vial Consumer Information (Wolters Kluwer)
- Somatropin (rDNA origin - refrigerated) vials Consumer Information (Wolters Kluwer)
- Somatropin Consumer Information (Cerner Multum)
- Somatropin, e-coli derived Subcutaneous, Injection Advanced Consumer Information (Micromedex®)
- Somatropin, mammalian derived Subcutaneous, 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.|