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Generic Cleviprex Availability

Cleviprex is a brand name of clevidipine, approved by the FDA in the following formulation(s):

CLEVIPREX (clevidipine - emulsion;intravenous)

  • Manufacturer: CHIESI USA INC
    Approval date: August 1, 2008
    Strength(s): 25MG/50ML (0.5MG/ML) [RLD], 50MG/100ML (0.5MG/ML) [RLD]
  • Manufacturer: CHIESI USA INC
    Approval date: November 8, 2013
    Strength(s): 125MG/250ML (0.5MG/ML) [RLD]

Has a generic version of Cleviprex been approved?

No. There is currently no therapeutically equivalent version of Cleviprex available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Cleviprex. 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.

Related Patents

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.

  • Short-acting dihydropyridines
    Patent 5,856,346
    Issued: January 5, 1999
    Inventor(s): Andersson; Kjell Hjalmar & Nordlander; Margareta & Westerlund; Rolf Christer
    Assignee(s): Astra Aktiebolag
    Compounds of the general formula ##STR1## wherein R.sub.1 and R.sub.2 are independently selected from the group consisting of hydrogen, chloro, bromo, nitro, cyano, trifluoromethyl, and R.sub.3 and R.sub.4 are independently selected from straight or branched lower (1-5 carbon atoms) alkyl groups, and including all optical isomers, provided that when R.sub.3 is methyl and R.sub.4 is tert.-butyl, then R.sub.1 /R.sub.2 are not hydrogen/hydrogen, hydrogen/2'-trifluormethyl, 2'-chloro/3'-chloro, and when R.sub.3 is methyl and R.sub.1 /R.sub.2 is hydrogen/3'-nitro, then R.sub.4 are not methyl, ethyl, propyl, iso-propyl, tert.-butyl, processes for their preparation, pharmaceutical preparations containing them and the use of the compounds in lowering the blood pressure.
    Patent expiration dates:
    • January 5, 2021
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      Patent use: CLEVIPREX IS A DIHYDROPYRIDINE CALCIUM CHANNEL BLOCKER INDICATED FOR THE REDUCTION OF BLOOD PRESSURE WHEN ORAL THERAPY IS NOT FEASIBLE OR NOT DESIRABLE
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      Drug substance
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      Drug product
  • Clevidipine emulsion formulations containing antimicrobial agents
    Patent 8,658,676
    Issued: February 25, 2014
    Assignee(s): The Medicines Company
    Pharmaceutical formulations comprising clevidipine in an oil-in-water formulation that is resistant to microbial growth and stable against the formation of impurities.
    Patent expiration dates:
    • October 10, 2031
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      Drug product

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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