Generic Precedex Availability
PRECEDEX (dexmedetomidine hydrochloride - injectable; injection)
Approval date: December 17, 1999
Strength(s): EQ 100MCG BASE/ML (EQ100MCG BASE/ML) [RLD]
Approval date: March 13, 2013
Strength(s): EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) [RLD], EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) [RLD]
Has a generic version of Precedex been approved?
No. There is currently no therapeutically equivalent version of Precedex available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Precedex. 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.
Optical isomer of an imidazole derivative medetomidine as an alpha-2-receptor agonist
Issued: March 20, 1990
Inventor(s): Karjalainen; Arto J. & Virtanen; Raimo E. & Savolainen; Eino J.
Assignee(s): Farmos Yhtyma Oy
The separated d and l enantiomers of medetomidine and their salts are selective and potent .alpha..sub.2 -receptor agonists.Patent expiration dates:
- July 15, 2013✓✓✓
- January 15, 2014✓
- July 15, 2013
Use of dexmedetomidine for ICU sedation
Issued: April 6, 2004
Inventor(s): Riku; Aantaa & Romeo; Bachand & Esa; Heinonen
Assignee(s): Orion Corporation
The present invention relates to a method of sedating a patient while in the intensive care unit comprising administering dexmedetomidine of a pharmaceutically acceptable salt thereof to the patient, wherein the patient remains arousable and orientated.Patent expiration dates:
- March 31, 2019✓
- October 1, 2019✓
- March 31, 2019
|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.|