WELCHOL Drug Patent Profile
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When do Welchol patents expire, and what generic alternatives are available?
Welchol is a drug marketed by Cosette and is included in four NDAs.
The generic ingredient in WELCHOL is colesevelam hydrochloride. There are ten drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the colesevelam hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Welchol
A generic version of WELCHOL was approved as colesevelam hydrochloride by IMPAX LABS INC on May 16th, 2018.
Summary for WELCHOL
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 4 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 22 |
Clinical Trials: | 28 |
Patent Applications: | 1,370 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for WELCHOL |
What excipients (inactive ingredients) are in WELCHOL? | WELCHOL excipients list |
DailyMed Link: | WELCHOL at DailyMed |
Recent Clinical Trials for WELCHOL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Entera Health, Inc | Phase 2 |
Valeant Pharmaceuticals International, Inc. | Phase 4 |
Bausch Health Americas, Inc. | Phase 4 |
Pharmacology for WELCHOL
Drug Class | Bile Acid Sequestrant |
Mechanism of Action | Bile-acid Binding Activity |
Anatomical Therapeutic Chemical (ATC) Classes for WELCHOL
Paragraph IV (Patent) Challenges for WELCHOL
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
WELCHOL | Powder for Oral Suspension | colesevelam hydrochloride | 1.875 g/Packet and 3.75 g/Packet | 022362 | 1 | 2010-04-09 |
WELCHOL | Tablets | colesevelam hydrochloride | 625 mg | 021176 | 1 | 2009-07-01 |
US Patents and Regulatory Information for WELCHOL
WELCHOL is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting WELCHOL
INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES
Exclusivity Expiration: ⤷ Sign Up
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cosette | WELCHOL | colesevelam hydrochloride | BAR, CHEWABLE;ORAL | 210895-001 | Apr 3, 2019 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-002 | Oct 2, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cosette | WELCHOL | colesevelam hydrochloride | CAPSULE;ORAL | 021141-001 | May 26, 2000 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-001 | Oct 2, 2009 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for WELCHOL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cosette | WELCHOL | colesevelam hydrochloride | TABLET;ORAL | 021176-001 | May 26, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | WELCHOL | colesevelam hydrochloride | TABLET;ORAL | 021176-001 | May 26, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-002 | Oct 2, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-002 | Oct 2, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for WELCHOL
See the table below for patents covering WELCHOL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 1392331 | ⤷ Sign Up | |
European Patent Office | 1392331 | UTILISATION DU COLESEVELAM OU DE L'HYDROCHLORURE DE SEVELAMER POUR RÉDUIRE LE GLUCOSE SÉRIQUE (USE OF COLESEVELAM OR SEVELAMER HYDROGEN CHLORIDE FOR LOWERING SERUM GLUCOSE) | ⤷ Sign Up |
Israel | 142419 | ⤷ Sign Up | |
Brazil | 0209134 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for WELCHOL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0764174 | SPC/GB04/031 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTERED: UK EU/1/03/268/001-003 20040310 |
0764174 | C300159 | Netherlands | ⤷ Sign Up | PRODUCT NAME: COLESEVELAM, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/03/268/001 20040310 |
0764174 | 91100 | Luxembourg | ⤷ Sign Up | 91100, EXPIRES: 20190310 |
0764174 | 04C0021 | France | ⤷ Sign Up | PRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/03/268/001 20040310 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |