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
(2 years 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
(10 years ago) |
Expired
|
|
US6066678 (Pediatric) | Process for removing bile salts from a patient and alkylated compositions therefor |
Oct, 2014
(10 years ago) |
Expired
|
|
US5607669 (Pediatric) | Amine polymer sequestrant and method of cholesterol depletion |
Dec, 2014
(10 years ago) |
Expired
|
|
US6433026 (Pediatric) | Process for removing bile salts from a patient and alkylated compositions therefor |
Oct, 2014
(10 years ago) |
Expired
|
| US5693675 | Alkylated amine polymers |
Dec, 2014
(10 years ago) |
Expired
|
|
US5679717 (Pediatric) | Method for removing bile salts from a patient with alkylated amine polymers |
Oct, 2014
(10 years ago) |
Expired
|
|
US5917007 (Pediatric) | Process for removing bile salts from a patient and alkylated compositions therefor |
Oct, 2014
(10 years ago) |
Expired
|
|
US6784254 (Pediatric) | Process for removing bile salts from a patient and alkylated compositions therefor |
Oct, 2014
(10 years ago) |
Expired
|
|
US7101960 (Pediatric) | Process for removing bile salts from a patient and alkylated compositions therefor |
Oct, 2014
(10 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.
Latest 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 |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 29 Nov, 2018 | US7229613 |
| Expire Patent Critical | 08 Oct, 2018 | US7101960 |
| Maintenance Fee Reminder Mailed Critical | 16 Apr, 2018 | US7101960 |
| Post Issue Communication - Certificate of Correction | 24 Apr, 2008 | US7101960 |
| PARALEGAL OR ELECTRONIC TERMINAL DISCLAIMER APPROVED Critical | 10 Mar, 2008 | US6784254 |
| Terminal Disclaimer Filed Critical | 04 Feb, 2008 | US6784254 |
| Patent Issue Date Used in PTA Calculation Critical | 12 Jun, 2007 | US7229613 |
| Recordation of Patent Grant Mailed Critical | 12 Jun, 2007 | US7229613 |
| Issue Notification Mailed Critical | 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. All of its exclusivities have expired 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 |
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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 |
| |||||||||
| Boehringer Ingelheim |
| |||||||||
| Janssen Pharms |
| |||||||||
| Sb Pharmco |
| |||||||||
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, capsule form for oral use, for suspension form for oral use, bar, chewable 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 |