Generic Welchol Availability

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

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.

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.

  • Amine polymer sequestrant and method of cholesterol depletion
    Patent 5,607,669
    Issued: March 4, 1997
    Inventor(s): Mandeville, III; W. Harry & Holmes-Farley; Stephen R.
    Assignee(s): GelTex Pharmaceuticals, Inc.
    An amine polymer includes first and second substituents bound to amines of the polymer. The first substituent includes a hydrophobic moiety. The second substituent includes a quaternary amine-containing moiety. A method for binding bile salts of bile acids in a mammal includes orally administering to the mammal a therapeutically-effective amount of the amine polymer.
    Patent expiration dates:
    • June 10, 2014
      ✓ 
      Patent use: USE AS A BILE ACID SEQUESTRANT
    • June 10, 2014
      ✓ 
      Patent use: USE AS A BILE ACID SEQUESTRANT FOR LOWERING CHOLESTEROL
    • December 10, 2014
      ✓ 
      Pediatric exclusivity
  • Method for removing bile salts from a patient with alkylated amine polymers
    Patent 5,679,717
    Issued: October 21, 1997
    Inventor(s): Mandeville, III; W. Harry & Holmes-Farley; Stephen Randall
    Assignee(s): GelTex Pharmaceuticals, Inc.
    A method for removing bile salts from a patient that includes administering to the patient a therapeutically effective amount of product produced by a process comprising alkylating one or more crosslinked amine polymers, salts or copolymers thereof with at least one alkylating agent. The reaction product is characterized in that: (i) at least some of the nitrogen atoms are unreacted with alkylating agent; and (ii) less than 10 mol% of the nitrogen atoms in the polymer react with the alkylating agent to form quaternary ammonium units.
    Patent expiration dates:
    • April 29, 2014
      ✓ 
      Patent use: USE AS A BILE ACID SEQUESTRANT
    • April 29, 2014
      ✓ 
      Patent use: USE AS A BILE ACID SEQUESTRANT FOR LOWERING CHOLESTEROL
    • October 29, 2014
      ✓ 
      Pediatric exclusivity
  • Alkylated amine polymers
    Patent 5,693,675
    Issued: December 2, 1997
    Inventor(s): Mandeville, III; W. Harry & Holmes-Farley; Stephen Randall
    Assignee(s): GelTex Pharmaceuticals Inc.
    The invention relates to alkylated amine polymers and a method for removing bile salts from a patient that includes administering to the patient a therapeutically effective amount of product produced by a process comprising alkylating one or more crosslinked amine polymers, salts or copolymers thereof with at least one alkylating agent. The reaction product is characterized in that: (i) at least some of the nitrogen atoms are unreacted with alkylating agent; and (ii) less than 10 mol % of the nitrogen atoms in the polymer react with the alkylating agent to form quaternary ammonium units.
    Patent expiration dates:
    • December 2, 2014
    • December 2, 2014
      ✓ 
      Drug substance
    • June 2, 2015
      ✓ 
      Pediatric exclusivity
  • Process for removing bile salts from a patient and alkylated compositions therefor
    Patent 5,917,007
    Issued: June 29, 1999
    Inventor(s): Mandeville, III; W. Harry & Holmes-Farley; Stephen Randall
    Assignee(s): GelTex Pharmaceuticals, Inc.
    The invention relates to a method for removing bile salts from a patient in need thereof and compositions useful in the method. The method comprises administering to the patient a therapeutically effective amount of an alkylated and crosslinked polymer. The alkylated and crosslinked polymer comprises the reaction product of polymers, or salts and copolymers thereof having amine containing repeat units, with at least one aliphatic alkylating agent and a crosslinking agent.
    Patent expiration dates:
    • April 29, 2014
      ✓ 
      Patent use: USE AS A BILE ACID SEQUESTRANT
    • April 29, 2014
      ✓ 
      Patent use: USE AS A BILE ACID SEQUESTRANT
      ✓ 
      Drug substance
    • April 29, 2014
      ✓ 
      Patent use: USE AS A BILE ACID SEQUESTRANT FOR LOWERING CHOLESTEROL
      ✓ 
      Drug substance
    • October 29, 2014
      ✓ 
      Pediatric exclusivity
  • Amine polymer sequestrant and method of cholesterol depletion
    Patent 5,919,832
    Issued: July 6, 1999
    Inventor(s): Mandeville, III; W. Harry & Holmes-Farley; Stephen Randall
    Assignee(s): Geltex Pharmaceuticals Inc.
    An amine polymer includes first and second substituents bound to amines of the polymer. The first substituent includes a hydrophobic moiety. The second substituent includes a quaternary amine-containing moiety. A method for binding bile salts of bile acids in a mammal includes orally administering to the mammal a therapeutically-effective amount of the amine polymer.
    Patent expiration dates:
    • June 10, 2014
    • April 29, 2014
      ✓ 
      Drug substance
    • December 10, 2014
      ✓ 
      Pediatric exclusivity
    • October 29, 2014
      ✓ 
      Pediatric exclusivity
  • Process for removing bile salts from a patient and alkylated compositions therefor
    Patent 6,066,678
    Issued: May 23, 2000
    Inventor(s): Mandeville, III; W. Harry & Holmes-Farley; Stephen Randall
    Assignee(s): GelTex Pharmaceuticals, Inc.
    The invention relates to a method for removing bile salts from a patient in need thereof and compositions useful in the method. The method comprises administering to the patient a therapeutically effective amount of an alkylated and crosslinked polymer. The alkylated and crosslinked polymer comprises the reaction product of polymers, or salts and copolymers thereof having amine containing repeat units, with at least one aliphatic alkylating agent and a crosslinking agent.
    Patent expiration dates:
    • June 10, 2014
      ✓ 
      Patent use: USE AS A BILE ACID SEQUESTRANT
    • April 29, 2014
      ✓ 
      Patent use: USE AS A BILE ACID SEQUESTRANT
      ✓ 
      Drug substance
    • April 29, 2014
      ✓ 
      Patent use: USE AS A BILE ACID SEQUESTRANT FOR LOWERING CHOLESTEROL
      ✓ 
      Drug substance
    • December 10, 2014
      ✓ 
      Pediatric exclusivity
    • October 29, 2014
      ✓ 
      Pediatric exclusivity
  • Process for removing bile salts from a patient and alkylated compositions therefor
    Patent 6,433,026
    Issued: August 13, 2002
    Inventor(s): W. Harry; Mandeville, III & Stephen Randall; Holmes-Farley
    Assignee(s): GelTex Pharmaceuticals, Inc.
    The invention relates to a method for removing bile salts from a patient in need thereof and compositions useful in the method. The method comprises administering to the patient a therapeutically effective amount of a salt of an alkylated and crosslinked polymer. The alkylated and crosslinked polymer salt comprises the reaction product of crosslinked polymers, or salts and copolymers thereof having amine containing repeat units, with at least one aliphatic alkylating agent.
    Patent expiration dates:
    • June 10, 2014
    • April 29, 2014
      ✓ 
      Drug substance
    • December 10, 2014
      ✓ 
      Pediatric exclusivity
    • October 29, 2014
      ✓ 
      Pediatric exclusivity
  • Process for removing bile salts from a patient and alkylated compositions therefor
    Patent 6,784,254
    Issued: August 31, 2004
    Inventor(s): W. Harry; Mandeville, III & Stephen Randall; Holmes-Farley
    Assignee(s): Genzyme Corporation
    The invention relates to a method for removing bile salts from a patient in need thereof and compositions useful in the method. The method comprises administering to the patient a therapeutically effective amount of a salt of an alkylated and crosslinked polymer. The alkylated and crosslinked polymer salt comprises the reaction product of crosslinked polymers, or salts and copolymers thereof having amine containing repeat units, with at least one aliphatic alkylating agent.
    Patent expiration dates:
    • April 29, 2014
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • October 29, 2014
      ✓ 
      Pediatric exclusivity
  • Process for removing bile salts from a patient and alkylated compositions therefor
    Patent 7,101,960
    Issued: September 5, 2006
    Inventor(s): Mandeville, III; W. Harry & Holmes-Farley; Stephen Randall
    Assignee(s): Genzyme Corporation
    The invention relates to a method for reducing serum cholesterol in a patient in need thereof and alkylated and crosslinked poly(allylamine) polymers useful in the method. The alkylated and crosslinked poly(allylamine) polymers are crosslinked with epichlorohydrin and comprise at least some n-decyl substituted nitrogen atoms and at least some hexyltrimethyl ammonium substituted nitrogen atoms.
    Patent expiration dates:
    • April 29, 2014
      ✓ 
      Patent use: USE AS A BILE ACID SEQUESTRANT FOR LOWERING CHOLESTEROL
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • October 29, 2014
      ✓ 
      Pediatric exclusivity
  • 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

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:
    • October 2, 2012 - REDUCE LDL-C LEVELS IN BOYS AND POSTMENARCHAL GIRLS, 10 TO 17 YEARS OF AGE, WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA AS MONOTHERAPY OR IN COMBINATION WITH A STATIN AFTER FAILING AN ADEQUATE TRIAL OF DIET THERAPY
    • April 2, 2013 - PEDIATRIC EXCLUSIVITY

See also...

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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