WELCHOL Drug Patent Profile
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Which patents cover Welchol, and when can generic versions of Welchol launch?
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. Eighteen 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: | 21 |
| 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 |
| Bausch Health Americas, Inc. | Phase 4 |
| LMC Diabetes & Endocrinology Ltd. | 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: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-002 | Oct 2, 2009 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Cosette | WELCHOL | colesevelam hydrochloride | CAPSULE;ORAL | 021141-001 | May 26, 2000 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-001 | Oct 2, 2009 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Cosette | WELCHOL | colesevelam hydrochloride | TABLET;ORAL | 021176-001 | May 26, 2000 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-002 | Oct 2, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-001 | Oct 2, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cosette | WELCHOL | colesevelam hydrochloride | BAR, CHEWABLE;ORAL | 210895-001 | Apr 3, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-002 | Oct 2, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cosette | WELCHOL | colesevelam hydrochloride | FOR SUSPENSION;ORAL | 022362-002 | Oct 2, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| Canada | 2191478 | PROCEDE POUR ELIMINER LES SELS BILIAIRES CHEZ UN PATIENT ET COMPOSITIONS ALKYLEES A CET EFFET (PROCESS FOR REMOVING BILE SALTS FROM A PATIENT AND ALKYLATEDCOMPOSITIONS THEREFOR) | ⤷ Try a Trial |
| Spain | 2304437 | ⤷ Try a Trial | |
| 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) | ⤷ Try a Trial |
| Russian Federation | 2160742 | METHOD OF WITHDRAWING GALL-STONES FROM PATENT'S BODY (VARIANTS) AND ALKYLATED CROSS-LINKED POLYMER FOR CARRYING IN THROUGH | ⤷ Try a Trial |
| Japan | H09500368 | ⤷ Try a Trial | |
| China | 1155287 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for WELCHOL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0764174 | SPC013/2004 | Ireland | ⤷ Try a Trial | SPC013/2004: 20050912, EXPIRES: 20190309 |
| 0764174 | SPC/GB04/031 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTERED: UK EU/1/03/268/001-003 20040310 |
| 0764174 | C300159 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COLESEVELAM, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/03/268/001 20040310 |
| 0764174 | 300159 | Netherlands | ⤷ Try a Trial | 300159, 20150605, EXPIRES: 20190309 |
| 0764174 | 04C0021 | France | ⤷ Try a Trial | PRODUCT NAME: COLESEVELAM HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/03/268/001 20040310 |
| 0764174 | 91100 | Luxembourg | ⤷ Try a Trial | 91100, EXPIRES: 20190310 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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