Generic Belsomra Availability
BELSOMRA (suvorexant - tablet;oral)
Manufacturer: MERCK SHARP DOHME
Approval date: August 13, 2014
Strength(s): 5MG [RLD], 10MG [RLD], 15MG [RLD], 20MG [RLD]
Has a generic version of Belsomra been approved?
No. There is currently no therapeutically equivalent version of Belsomra available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Belsomra. 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 FAQs.
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.
Substituted diazepan orexin receptor antagonists
Issued: May 31, 2011
Inventor(s): Breslin; Michael J. & Coleman; Paul J. & Cox; Christopher D.
Assignee(s): Merck Sharp & Dohme Corp.
The present invention is directed to substituted diazepan compounds which are antagonists of orexin receptors, and which are useful in the treatment or prevention of neurological and psychiatric disorders and diseases in which orexin receptors are involved. The invention is also directed to pharmaceutical compositions comprising these compounds and the use of these compounds and compositions in the prevention or treatment of such diseases in which orexin receptors are involved.
Patent expiration dates:
- November 20, 2029✓✓✓
- November 20, 2029
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:
- August 13, 2019 - NEW CHEMICAL ENTITY
More about Belsomra (suvorexant)
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- Drug class: miscellaneous anxiolytics, sedatives and hypnotics
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|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.|