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

Sponsor	Phase
Ain Shams University	Phase 4
Instituto Nacional de Salud Publica, Mexico	Phase 3
Laboratorios Grossman, S.A.	Phase 3

See all COLESTIPOL HYDROCHLORIDE clinical trials

Pharmacology for COLESTIPOL HYDROCHLORIDE

Drug Class	Bile Acid Sequestrant
Mechanism of Action	Bile-acid Binding Activity

Medical Subject Heading (MeSH) Categories for COLESTIPOL HYDROCHLORIDE

Anion Exchange Resins
Hypolipidemic Agents
Sequestering Agents

Anatomical Therapeutic Chemical (ATC) Classes for COLESTIPOL HYDROCHLORIDE

C10AC	Bile acid sequestrants
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for COLESTIPOL HYDROCHLORIDE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
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	077277-002	May 2, 2006	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Edenbridge Pharms	COLESTIPOL HYDROCHLORIDE	colestipol hydrochloride	TABLET;ORAL	217667-001	Aug 16, 2024	AB	RX	No	No	⤷ 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

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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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