Welchol Patent Expiration

Welchol is a drug owned by Cosette Pharmaceuticals Inc. It is protected by 20 US drug patents filed from 2013 to 2019 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 20, 2024. Details of Welchol's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7229613

(Pediatric)

Method for lowering serum glucose
Oct, 2022

(1 year, 11 months ago)

Expired
US7229613 Method for lowering serum glucose
Apr, 2022

(2 years ago)

Expired
US5693675

(Pediatric)

Alkylated amine polymers
Jun, 2015

(9 years ago)

Expired
US5919832

(Pediatric)

Amine polymer sequestrant and method of cholesterol depletion
Oct, 2014

(9 years ago)

Expired
US6066678

(Pediatric)

Process for removing bile salts from a patient and alkylated compositions therefor
Oct, 2014

(9 years ago)

Expired
US5607669

(Pediatric)

Amine polymer sequestrant and method of cholesterol depletion
Dec, 2014

(9 years ago)

Expired
US6433026

(Pediatric)

Process for removing bile salts from a patient and alkylated compositions therefor
Oct, 2014

(9 years ago)

Expired
US5693675 Alkylated amine polymers
Dec, 2014

(9 years ago)

Expired
US5679717

(Pediatric)

Method for removing bile salts from a patient with alkylated amine polymers
Oct, 2014

(9 years ago)

Expired
US5917007

(Pediatric)

Process for removing bile salts from a patient and alkylated compositions therefor
Oct, 2014

(9 years ago)

Expired
US6784254

(Pediatric)

Process for removing bile salts from a patient and alkylated compositions therefor
Oct, 2014

(9 years ago)

Expired
US7101960

(Pediatric)

Process for removing bile salts from a patient and alkylated compositions therefor
Oct, 2014

(9 years ago)

Expired
US6433026 Process for removing bile salts from a patient and alkylated compositions therefor
Apr, 2014

(10 years ago)

Expired
US5607669 Amine polymer sequestrant and method of cholesterol depletion
Jun, 2014

(10 years ago)

Expired
US6066678 Process for removing bile salts from a patient and alkylated compositions therefor
Apr, 2014

(10 years ago)

Expired
US5919832 Amine polymer sequestrant and method of cholesterol depletion
Apr, 2014

(10 years ago)

Expired
US5917007 Process for removing bile salts from a patient and alkylated compositions therefor
Apr, 2014

(10 years ago)

Expired
US7101960 Process for removing bile salts from a patient and alkylated compositions therefor
Apr, 2014

(10 years ago)

Expired
US5679717 Method for removing bile salts from a patient with alkylated amine polymers
Apr, 2014

(10 years ago)

Expired
US6784254 Process for removing bile salts from a patient and alkylated compositions therefor
Apr, 2014

(10 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Welchol's patents.

Given below is the list of recent legal activities going on the following patents of Welchol.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 29 Nov, 2018 US7229613
Expire Patent 08 Oct, 2018 US7101960
Maintenance Fee Reminder Mailed 16 Apr, 2018 US7101960
Post Issue Communication - Certificate of Correction 24 Apr, 2008 US7101960
PARALEGAL OR ELECTRONIC TERMINAL DISCLAIMER APPROVED 10 Mar, 2008 US6784254
Terminal Disclaimer Filed 04 Feb, 2008 US6784254
Patent Issue Date Used in PTA Calculation 12 Jun, 2007 US7229613
Recordation of Patent Grant Mailed 12 Jun, 2007 US7229613
Issue Notification Mailed 23 May, 2007 US7229613
Dispatch to FDC 04 May, 2007 US7229613


FDA has granted several exclusivities to Welchol. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Welchol, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Welchol.

Exclusivity Information

Welchol holds 3 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2024. Details of Welchol's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-608) Oct 02, 2012
Pediatric Exclusivity(PED) Apr 02, 2013
M(M-232) Oct 20, 2024

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

US patents provide insights into the exclusivity only within the United States, but Welchol is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Welchol's family patents as well as insights into ongoing legal events on those patents.

Welchol's Family Patents

Welchol has patent protection in a total of 18 countries. It's US patent count contributes only to 32.5% of its total global patent coverage. 11 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Welchol.

Family Patents

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Generic Launch

Generic Release Date:

Welchol's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 20, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Welchol Generics:

Colesevelam Hydrochloride is the generic name for the brand Welchol. 14 different companies have already filed for the generic of Welchol, with Watson Labs Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Welchol's generic

How can I launch a generic of Welchol before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Welchol's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Welchol's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Welchol -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
1.875 g/Packet and 3.75 g/Packet 09 Apr, 2010 1 02 Dec, 2014 Extinguished
625 mg 01 Jul, 2009 1 16 May, 2018 10 Dec, 2014 Extinguished

Alternative Brands for Welchol

Welchol which is used for lowering serum glucose levels in adults with type 2 diabetes mellitus and lowering cholesterol levels., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Astrazeneca Ab
Qtern Used for the treatment of type 2 diabetes mellitus in patients who have inadequate control with dapagliflozin.
Farxiga used for treating heart failure and type 2 diabetes.
Xigduo Xr used for managing type 2 diabetes mellitus when glycemic control is not achievable with other medications.
Qternmet Xr Used for managing blood sugar levels in individuals with type 2 diabetes mellitus.
Boehringer Ingelheim
Tradjenta Used for treating type 2 diabetes, especially in patients with renal impairment and insufficient glycemic control.
Janssen Pharms
Invokana used for the treatment of type 2 diabetes mellitus and reduction of cardiovascular and kidney-related risks.
Invokamet Used for reducing the risk of kidney disease, cardiovascular events, and treating type 2 diabetes mellitus patients.
Invokamet Xr used for treating type 2 diabetes and reducing the risk of kidney disease, cardiovascular events, and heart failure.
Sb Pharmco
Avandamet Used for managing and treating type 2 diabetes mellitus.





About Welchol

Welchol is a drug owned by Cosette Pharmaceuticals Inc. It is used for lowering serum glucose levels in adults with type 2 diabetes mellitus and lowering cholesterol levels. Welchol uses Colesevelam Hydrochloride as an active ingredient. Welchol was launched by Cosette in 2000.

Approval Date:

Welchol was approved by FDA for market use on 26 May, 2000.

Active Ingredient:

Welchol uses Colesevelam Hydrochloride as the active ingredient. Check out other Drugs and Companies using Colesevelam Hydrochloride ingredient

Treatment:

Welchol is used for lowering serum glucose levels in adults with type 2 diabetes mellitus and lowering cholesterol levels.

Dosage:

Welchol is available in the following dosage forms - tablet form for oral use, bar, chewable form for oral use, for suspension form for oral use, capsule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
625MG TABLET Prescription ORAL
3.75GM/PACKET FOR SUSPENSION Prescription ORAL
1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SUSPENSION Discontinued ORAL
3.75GM BAR, CHEWABLE Discontinued ORAL
375MG CAPSULE Discontinued ORAL