Colesevelam Hydrochloride Patent Expiration

Colesevelam Hydrochloride is Used for lowering serum glucose levels in adults with type 2 diabetes mellitus and lowering cholesterol levels. It was first introduced by Cosette Pharmaceuticals Inc in its drug Welchol on May 26, 2000. 15 different companies have introduced drugs containing Colesevelam Hydrochloride.


Colesevelam Hydrochloride Patents

Given below is the list of patents protecting Colesevelam Hydrochloride, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Welchol US7229613

(Pediatric)

Method for lowering serum glucose Oct 17, 2022

(Expired)

Cosette
Welchol US7229613 Method for lowering serum glucose Apr 17, 2022

(Expired)

Cosette
Welchol US5693675

(Pediatric)

Alkylated amine polymers Jun 02, 2015

(Expired)

Cosette
Welchol US5607669

(Pediatric)

Amine polymer sequestrant and method of cholesterol depletion Dec 10, 2014

(Expired)

Cosette
Welchol US5919832

(Pediatric)

Amine polymer sequestrant and method of cholesterol depletion Dec 10, 2014

(Expired)

Cosette
Welchol US6066678

(Pediatric)

Process for removing bile salts from a patient and alkylated compositions therefor Dec 10, 2014

(Expired)

Cosette
Welchol US6433026

(Pediatric)

Process for removing bile salts from a patient and alkylated compositions therefor Dec 10, 2014

(Expired)

Cosette
Welchol US5693675 Alkylated amine polymers Dec 02, 2014

(Expired)

Cosette
Welchol US5679717

(Pediatric)

Method for removing bile salts from a patient with alkylated amine polymers Oct 29, 2014

(Expired)

Cosette
Welchol US5917007

(Pediatric)

Process for removing bile salts from a patient and alkylated compositions therefor Oct 29, 2014

(Expired)

Cosette
Welchol US5919832

(Pediatric)

Amine polymer sequestrant and method of cholesterol depletion Oct 29, 2014

(Expired)

Cosette
Welchol US6066678

(Pediatric)

Process for removing bile salts from a patient and alkylated compositions therefor Oct 29, 2014

(Expired)

Cosette
Welchol US6433026

(Pediatric)

Process for removing bile salts from a patient and alkylated compositions therefor Oct 29, 2014

(Expired)

Cosette
Welchol US6784254

(Pediatric)

Process for removing bile salts from a patient and alkylated compositions therefor Oct 29, 2014

(Expired)

Cosette
Welchol US7101960

(Pediatric)

Process for removing bile salts from a patient and alkylated compositions therefor Oct 29, 2014

(Expired)

Cosette
Welchol US5607669 Amine polymer sequestrant and method of cholesterol depletion Jun 10, 2014

(Expired)

Cosette
Welchol US5919832 Amine polymer sequestrant and method of cholesterol depletion Jun 10, 2014

(Expired)

Cosette
Welchol US6066678 Process for removing bile salts from a patient and alkylated compositions therefor Jun 10, 2014

(Expired)

Cosette
Welchol US6433026 Process for removing bile salts from a patient and alkylated compositions therefor Jun 10, 2014

(Expired)

Cosette
Welchol US5679717 Method for removing bile salts from a patient with alkylated amine polymers Apr 29, 2014

(Expired)

Cosette
Welchol US5917007 Process for removing bile salts from a patient and alkylated compositions therefor Apr 29, 2014

(Expired)

Cosette
Welchol US5919832 Amine polymer sequestrant and method of cholesterol depletion Apr 29, 2014

(Expired)

Cosette
Welchol US6066678 Process for removing bile salts from a patient and alkylated compositions therefor Apr 29, 2014

(Expired)

Cosette
Welchol US6433026 Process for removing bile salts from a patient and alkylated compositions therefor Apr 29, 2014

(Expired)

Cosette
Welchol US6784254 Process for removing bile salts from a patient and alkylated compositions therefor Apr 29, 2014

(Expired)

Cosette
Welchol US7101960 Process for removing bile salts from a patient and alkylated compositions therefor Apr 29, 2014

(Expired)

Cosette



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 Colesevelam Hydrochloride's patents.

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

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


Colesevelam Hydrochloride's Family Patents

Family Patents

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Colesevelam Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Colesevelam Hydrochloride. The first generic version for Colesevelam Hydrochloride was by Impax Laboratories Inc and was approved on May 16, 2018. And the latest generic version is by Impax Laboratories Llc and was approved on Jan 18, 2023.

Given below is the list of companies who have filed for Colesevelam Hydrochloride generic, along with the locations of their manufacturing plants worldwide.


1. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 2 different strengths of generic version for Colesevelam Hydrochloride. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
625MG

tablet Prescription ORAL AB Oct 5, 2018
3.75GM/PACKET

for suspension Prescription ORAL AB May 6, 2019





2. BEIJING TIDE PHARM

Beijing Tide Pharmaceutical Co Ltd has filed for 1 generic for Colesevelam Hydrochloride. Given below are the details of the strengths of this generic introduced by Beijing Tide Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
625MG

tablet Prescription ORAL AB Oct 14, 2021





3. BIONPHARMA

Bionpharma Inc has filed for 1 generic for Colesevelam Hydrochloride. Given below are the details of the strengths of this generic introduced by Bionpharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
625MG

tablet Prescription ORAL AB Sep 13, 2019


Manufacturing Plant Locations
New

Bionpharma's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Bionpharma as present at those locations.

Country City Firm Name
United States
Princeton Bionpharma Inc.





4. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 1 generic for Colesevelam Hydrochloride. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength Dosage Form Availability Application Pathway TE code Launch Date
625MG

tablet Discontinued ORAL N/A Dec 17, 2020





5. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 1 generic for Colesevelam Hydrochloride. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
625MG

tablet Prescription ORAL AB Oct 5, 2018





6. GLENMARK PHARMS LTD

Glenmark Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Colesevelam Hydrochloride. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
625MG

tablet Prescription ORAL AB May 18, 2018
1.875GM/PACKET

for suspension Prescription ORAL N/A Jul 16, 2018
3.75GM/PACKET

for suspension Prescription ORAL AB Jul 16, 2018





7. IMPAX

Impax Laboratories Llc has filed for 1 generic for Colesevelam Hydrochloride. Given below are the details of the strengths of this generic introduced by Impax.

Strength Dosage Form Availability Application Pathway TE code Launch Date
3.75GM/PACKET

for suspension Discontinued ORAL N/A Jan 18, 2023


Manufacturing Plant Locations
New

Impax's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Impax as present at those locations.

Country City Firm Name
United States
Hayward Impax Laboratories, LLC.





8. IMPAX LABS INC

Impax Laboratories Inc has filed for 1 generic for Colesevelam Hydrochloride. Given below are the details of the strengths of this generic introduced by Impax Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
625MG

tablet Prescription ORAL AB May 16, 2018





9. INVAGEN PHARMS

Invagen Pharmaceuticals Inc has filed for 1 generic for Colesevelam Hydrochloride. Given below are the details of the strengths of this generic introduced by Invagen Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
625MG

tablet Discontinued ORAL N/A Apr 20, 2020





10. INVENTIA

Inventia Healthcare Ltd has filed for 1 generic for Colesevelam Hydrochloride. Given below are the details of the strengths of this generic introduced by Inventia.

Strength Dosage Form Availability Application Pathway TE code Launch Date
625MG

tablet Prescription ORAL AB Dec 4, 2020


Manufacturing Plant Locations
New

Inventia's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Inventia as present at those locations.

Country City Firm Name
India
Thane Inventia Healthcare Limited
Thane Inventia Healthcare Pvt Ltd.





11. UNITED RES LABS

United Research Laboratories Llc has filed for 1 generic for Colesevelam Hydrochloride. Given below are the details of the strengths of this generic introduced by United Res Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
625MG

tablet Discontinued ORAL N/A Jan 21, 2022





12. WATSON LABS INC

Watson Laboratories Inc has filed for 3 different strengths of generic version for Colesevelam Hydrochloride. Given below are the details of the strengths of this generic introduced by Watson Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
3.75GM/PACKET

for suspension Discontinued ORAL N/A Sep 1, 2020
1.875GM/PACKET

for suspension Discontinued ORAL N/A Sep 1, 2020
625MG

tablet Discontinued ORAL N/A Sep 2, 2020





13. ZHEJIANG JINGXIN

Zhejiang Jingxin Pharmaceutical Co Ltd has filed for 1 generic for Colesevelam Hydrochloride. Given below are the details of the strengths of this generic introduced by Zhejiang Jingxin.

Strength Dosage Form Availability Application Pathway TE code Launch Date
625MG

tablet Prescription ORAL AB Jul 15, 2020





14. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Colesevelam Hydrochloride. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
625MG

tablet Prescription ORAL AB Oct 7, 2019