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Last Updated: November 2, 2024

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, Edenbridge Pharms, and Zydus Pharms, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for colestipol hydrochloride. Eight suppliers are listed for this compound.

Summary for COLESTIPOL HYDROCHLORIDE
US Patents:0
Tradenames:3
Applicants:5
NDAs:7
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 8
Raw Ingredient (Bulk) Api Vendors: 20
Clinical Trials: 11
Patent Applications: 662
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

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
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
Edenbridge Pharms COLESTIPOL HYDROCHLORIDE colestipol hydrochloride TABLET;ORAL 217667-001 Aug 16, 2024 AB RX No No ⤷  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
Ani Pharms COLESTIPOL HYDROCHLORIDE colestipol hydrochloride TABLET;ORAL 216517-001 Mar 10, 2023 AB RX No 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
Pfizer FLAVORED COLESTID colestipol hydrochloride GRANULE;ORAL 017563-002 Approved Prior to Jan 1, 1982 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 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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