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COLESTID

NDA

COLESTIPOL HYDROCHLORIDE | N020222 | PFIZER INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

3 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 3 - Colestipol hydrochloride PI Colestipol hydrochloride granules ... FDA-2021-P-0513 Hyman, Phelps & McNamara P.C. filed a suitability petition regarding colestipol hydrochloride granules for oral suspension, requesting FDA determination of the suitability of the proposed product formulation and manufacturing process for approval under the applicable regulatory pathway.	Suitability	2021-05-27	Denied	Hyman, Phelps & McNamara P.C.
Attachment 2 - COLESTID PI FLAVORED COLESTID- colestipol hydrochloride granul... FDA-2021-P-0513 Hyman, Phelps & McNamara P.C., on behalf of Pharmacia and Upjohn Company LLC, filed a suitability petition regarding Flavored COLESTID (colestipol hydrochloride granule, for suspension), seeking FDA assessment of the proposed formulation's suitability for approval under applicable regulatory pathway	Suitability	2021-05-27	Denied	Hyman, Phelps & McNamara P.C.
Attachment 1 - COLESTID Prescription Drug List re Suitability Petition from H... FDA-2021-P-0513 Hyman, Phelps & McNamara P.C. filed a petition regarding COLESTID's suitability for inclusion on a prescription drug list. The petition addresses regulatory considerations for COLESTID, a prescription medication, though the specific requested action and detailed rationale are not provided in this do	Suitability	2021-05-27	Denied	Hyman, Phelps & McNamara P.C.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 1 NDC

Highest NADAC/Unit

$0.6533

per ea

Lowest NADAC/Unit

$0.6533

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
59762045001COLESTIPOL HCL 1 GM TABLET	$0.6533	EA	Generic	—	2026-10-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$32.98

Highest Price

$265.58

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
59762-0450-01COLESTIPOL HCL 1GM TAB	$32.98	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-0450-01COLESTIPOL HCL 1GM TAB	$80.03	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
00009-0450-03COLESTID TAB	$201.76	Big4	Pfizer Inc.	06/30/2029
00009-0450-03COLESTID TAB	$265.58	FSS	Pfizer Inc.	06/30/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain6 active DMFs

6 active API suppliers hold Drug Master Files for this ingredient.

FORMOSA LABORATORIES INCCOLESTIPOL HYDROCHLORIDE

DMF 176512004

SOLARA ACTIVE PHARMA SCIENCES LTDCOLESTIPOL HYDROCHLORIDE USP

DMF 334232018

ZYDUS LIFESCIENCES LTDCOLESTIPOL HYDROCHLORIDE USP

DMF 334602019

RISING PHARMA HOLDING INCCOLESTIPOL HYDROCHLORIDE (POVIDONE PREMIX)

DMF 335422019

RAKS PHARMA PVT LTDCOLESTIPOL HYDROCHLORIDE USP

DMF 380262023

SUN PHARMACEUTICAL INDUSTRIES LTDCOLESTIPOL HYDROCHLORIDE USP

DMF 394132024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
May 26, 2017	SUPPL -6	View Letter (PDF)
May 23, 2014	SUPPL -5	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1GM

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 19, 1994

No patent or exclusivity listings for this strength.