COLESTIPOL HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for colestipol hydrochloride and what is the scope of freedom to operate?
Colestipol hydrochloride
is the generic ingredient in three branded drugs marketed by Pfizer, Impax Labs, Ani Pharms, and Zydus Pharms, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.There are two drug master file entries for colestipol hydrochloride. Seven suppliers are listed for this compound.
Summary for COLESTIPOL HYDROCHLORIDE
US Patents: | 0 |
Tradenames: | 3 |
Applicants: | 4 |
NDAs: | 6 |
Drug Master File Entries: | 2 |
Finished Product Suppliers / Packagers: | 7 |
Raw Ingredient (Bulk) Api Vendors: | 20 |
Clinical Trials: | 11 |
Patent Applications: | 662 |
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 |
Instituto Nacional de Salud Publica, Mexico | Phase 3 |
Laboratorios Grossman, S.A. | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pfizer | FLAVORED COLESTID | colestipol hydrochloride | GRANULE;ORAL | 017563-001 | Approved Prior to Jan 1, 1982 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Pfizer | COLESTID | colestipol hydrochloride | GRANULE;ORAL | 017563-004 | Sep 22, 1995 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Zydus Pharms | COLESTIPOL HYDROCHLORIDE | colestipol hydrochloride | TABLET;ORAL | 215223-001 | Mar 10, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Impax Labs | COLESTIPOL HYDROCHLORIDE | colestipol hydrochloride | GRANULE;ORAL | 077277-001 | May 2, 2006 | AB | RX | No | 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 COLESTIPOL HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pfizer | FLAVORED COLESTID | colestipol hydrochloride | GRANULE;ORAL | 017563-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | COLESTID | colestipol hydrochloride | TABLET;ORAL | 020222-001 | Jul 19, 1994 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | FLAVORED COLESTID | colestipol hydrochloride | GRANULE;ORAL | 017563-002 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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