COLESTIPOL HYDROCHLORIDE Drug Patent Profile
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When do Colestipol Hydrochloride patents expire, and when can generic versions of Colestipol Hydrochloride launch?
Colestipol Hydrochloride is a drug marketed by Impax Labs, Ani Pharms, and Zydus Pharms. and is included in four NDAs.
The generic ingredient in COLESTIPOL HYDROCHLORIDE is colestipol hydrochloride. There are two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the colestipol hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Colestipol Hydrochloride
A generic version of COLESTIPOL HYDROCHLORIDE was approved as colestipol hydrochloride by IMPAX LABS on May 2nd, 2006.
Summary for COLESTIPOL HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 20 |
| Clinical Trials: | 11 |
| Patent Applications: | 392 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in COLESTIPOL HYDROCHLORIDE? | COLESTIPOL HYDROCHLORIDE excipients list |
| DailyMed Link: | COLESTIPOL HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for COLESTIPOL HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ain Shams University | Phase 4 |
| Laboratorios Grossman, S.A. | Phase 3 |
| Instituto Nacional de Salud Publica, Mexico | Phase 3 |
Pharmacology for COLESTIPOL HYDROCHLORIDE
| Drug Class | Bile Acid Sequestrant |
| Mechanism of Action | Bile-acid Binding Activity |
Medical Subject Heading (MeSH) Categories for COLESTIPOL HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for COLESTIPOL HYDROCHLORIDE
US Patents and Regulatory Information for COLESTIPOL HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Impax Labs | COLESTIPOL HYDROCHLORIDE | colestipol hydrochloride | GRANULE;ORAL | 077277-001 | May 2, 2006 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Impax Labs | COLESTIPOL HYDROCHLORIDE | colestipol hydrochloride | TABLET;ORAL | 077510-001 | Oct 24, 2006 | AB | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Impax Labs | COLESTIPOL HYDROCHLORIDE | colestipol hydrochloride | GRANULE;ORAL | 077277-002 | May 2, 2006 | AB | RX | No | No | ⤷ 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 |
