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Generic Welchol Availability

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

WELCHOL (colesevelam hydrochloride - capsule;oral)

  • Manufacturer: DAIICHI SANKYO
    Approval date: May 26, 2000
    Strength(s): 375MG

WELCHOL (colesevelam hydrochloride - for suspension;oral)

  • Manufacturer: DAIICHI SANKYO
    Approval date: October 2, 2009
    Strength(s): 1.875GM/PACKET, 3.75GM/PACKET [RLD]

WELCHOL (colesevelam hydrochloride - tablet;oral)

Has a generic version of Welchol been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Welchol. 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 lowering serum glucose
    Patent 7,229,613
    Issued: June 12, 2007
    Inventor(s): Burke; Steven K. & Donovan; Joanne M.
    Assignee(s): Genzyme Corporation
    A method for treating hyperglycemia and/or reducing serum glucose levels in a patient that includes administering to the patient a therapeutically effective amount of an amine polymer is disclosed. In one embodiment, the amine polymer is aliphatic. Examples of polymers useful in an embodiment of the invention include sevelamer hydrogen chloride and colesevelam. The invention includes the use of amine polymers such as a cross-linked polymer characterized by a repeat unit having the formula: and salts and copolymers thereof, where n is a positive integer and x is zero or an integer between 1 and about 4. Also described is a use, for the manufacture of a medicament, of a polymer that lowers serum glucose.
    Patent expiration dates:
    • April 17, 2022
      ✓ 
      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS
    • April 17, 2022
      ✓ 
      Patent use: TREATMENT OF TYPE 2 DIABETES MELLITUS
    • October 17, 2022
      ✓ 
      Pediatric 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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