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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 [RLD] [AB], 3.75GM/PACKET [RLD] [AB]

WELCHOL (colesevelam hydrochloride - tablet;oral)

Has a generic version of Welchol been approved?

A generic version of Welchol has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Welchol and have been approved by the FDA:

colesevelam hydrochloride for suspension;oral

  • Manufacturer: GLENMARK PHARMS LTD
    Approval date: July 16, 2018
    Strength(s): 1.875GM/PACKET [AB], 3.75GM/PACKET [AB]

colesevelam hydrochloride tablet;oral

  • Manufacturer: ALKEM LABS LTD
    Approval date: October 5, 2018
    Strength(s): 625MG [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: October 5, 2018
    Strength(s): 625MG [AB]
  • Manufacturer: GLENMARK PHARMS LTD
    Approval date: May 18, 2018
    Strength(s): 625MG [AB]
  • Manufacturer: IMPAX LABS INC
    Approval date: May 16, 2018
    Strength(s): 625MG [AB]

Note: No generic formulation of the following product is available.

  • colesevelam hydrochloride - capsule;oral

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: Generic Drug FAQs.

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
    • April 17, 2022
    • October 17, 2022
      Pediatric exclusivity

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.