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Generic Cuvposa Availability

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

CUVPOSA (glycopyrrolate - solution;oral)

  • Manufacturer: MERZ PHARMS
    Approval date: July 28, 2010
    Strength(s): 1MG/5ML [RLD]

Has a generic version of Cuvposa been approved?

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

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

  • Method for increasing the bioavailability of glycopyrrolate
    Patent 7,638,552
    Issued: December 29, 2009
    Inventor(s): Roberts; Alan & Venkataraman; Balaji
    Assignee(s): Sciele Pharma, Inc.
    The invention relates to a method of increasing the bioavailability of glycopyrrolate by administration of a therapeutically effective amount of glycopyrrolate without food. The invention also provides a kit comprising a pharmaceutical composition comprising a therapeutically effective amount of glycopyrrolate and a pharmaceutically acceptable carrier, prescribing information including advice regarding the administration of glycopyrrolate without food to improve bioavailability, and a container.
    Patent expiration dates:
    • August 20, 2023
      ✓ 
      Patent use: REDUCE CHRONIC SEVERE DROOLING (I.E., SIALORRHEA) IN PATIENTS WITH NEUROLOGIC CONDITIONS ASSOCIATED WITH PROBLEM DROOLING
  • Method for increasing the bioavailability of glycopyrrolate
    Patent 7,816,396
    Issued: October 19, 2010
    Inventor(s): Roberts; Alan & Venkataraman; Balaji
    Assignee(s): Shionogi Pharma, Inc.
    The invention relates to a method of treating sialorrhea in a human patient, which comprises orally administering glycopyrrolate in a liquid solution to the human patient under fasted conditions.
    Patent expiration dates:
    • August 20, 2023
      ✓ 
      Patent use: REDUCE CHRONIC SEVERE DROOLING (I.E., SIALORRHEA) IN PATIENTS WITH NEUROLOGIC CONDITIONS ASSOCIATED WITH PROBLEM DROOLING

Related Exclusivities

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:
    • July 28, 2017 - ORPHAN DRUG EXCLUSIVITY

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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