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)
Manufacturer: DAIICHI SANKYO
Approval date: May 26, 2000
Strength(s): 625MG [RLD]
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:
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:
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
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Drug substance
- June 2, 2015
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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
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Patent use: USE AS A BILE ACID SEQUESTRANT
- April 29, 2014
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Patent use: USE AS A BILE ACID SEQUESTRANT
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Drug substance
- April 29, 2014
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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
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Drug substance
- December 10, 2014
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Pediatric exclusivity
- October 29, 2014
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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
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Patent use: USE AS A BILE ACID SEQUESTRANT
- April 29, 2014
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Patent use: USE AS A BILE ACID SEQUESTRANT
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Drug substance
- April 29, 2014
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Patent use: USE AS A BILE ACID SEQUESTRANT FOR LOWERING CHOLESTEROL
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Drug substance
- December 10, 2014
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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
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Drug substance
- December 10, 2014
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Pediatric exclusivity
- October 29, 2014
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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
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Drug substance
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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:
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:
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.
See also...
- Welchol Consumer Information (Wolters Kluwer)
- Welchol Suspension Consumer Information (Wolters Kluwer)
- Welchol Consumer Information (Cerner Multum)
- Welchol Advanced Consumer Information (Micromedex)
- WelChol AHFS DI Monographs (ASHP)
- Colesevelam Consumer Information (Wolters Kluwer)
- Colesevelam Suspension Consumer Information (Wolters Kluwer)
- Colesevelam Consumer Information (Cerner Multum)
- Colesevelam Advanced Consumer Information (Micromedex)
- Colesevelam Hydrochloride AHFS DI Monographs (ASHP)
