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Last Updated: June 20, 2024

Colestipol hydrochloride - Generic Drug Details


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What are the generic sources for colestipol hydrochloride and what is the scope of patent protection?

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
Recent Clinical Trials for colestipol hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Ain Shams UniversityPhase 4
Laboratorios Grossman, S.A.Phase 3
Instituto Nacional de Salud Publica, MexicoPhase 3

See all colestipol hydrochloride clinical trials

Pharmacology for colestipol hydrochloride
Drug ClassBile Acid Sequestrant
Mechanism of ActionBile-acid Binding Activity
Medical Subject Heading (MeSH) Categories 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 017563-002 Approved Prior to Jan 1, 1982 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pfizer COLESTID colestipol hydrochloride TABLET;ORAL 020222-001 Jul 19, 1994 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Impax Labs COLESTIPOL HYDROCHLORIDE colestipol hydrochloride TABLET;ORAL 077510-001 Oct 24, 2006 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ani Pharms COLESTIPOL HYDROCHLORIDE colestipol hydrochloride TABLET;ORAL 216517-001 Mar 10, 2023 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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