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FLAVORED COLESTID

NDA

COLESTIPOL HYDROCHLORIDE | N017563 | PFIZER INC

4 strengths0 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Hyman, Phelps & McNamara P.C. FDA-2021-P-0513 · 6 docket documents Hyman, Phelps & McNamara P.C. filed this suitability petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93 requesting that FDA declare Colestipol HCl, 2 gm/Packet, suitable for an ANDA, with the reference listed drug being P	Suitability	2021-05-27	Denied	Hyman, Phelps & McNamara P.C.

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

Clinical Trials

6 trials from ClinicalTrials.gov, 5 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Sorbent Therapy of the Cutaneous Porphyrias NCT01422915	Phase 2/3	Completed	Brigham and Women's Hospital	4	2011-05 → 2012-03
A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction NCT00203476	Phase 4	Completed	Tuscaloosa Research & Education Advancement Corporation	30	2005-05 → 2008-01
An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide NCT02400476	Phase 2	Completed	Puma Biotechnology, Inc.	563	2015-02 → 2021-04-22
Familial Atherosclerosis Treatment Study NCT00000512	Phase 3	Completed	University of Washington	146	1984-01 → 1989-08
Cholesterol-Lowering Atherosclerosis Study (CLAS)NCT00000599	Phase 3	Completed	National Heart, Lung, and Blood Institute (NHLBI)	—	1980-06 → 1994-11
Rapid Elimination Procedure of Teriflunomide With Colestipol Hydrochloride NCT02263547	Phase 1	Terminated	Derrick Scott Robertson	14	2015-03 → 2016-06

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$0.2807

per gm

Lowest NADAC/Unit

$0.2807

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
59762026003COLESTIPOL HCL GRANULES	$0.2807	GM	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$54.74

Highest Price

$424.20

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
59762-0260-03COLESTIPOL GRANULES	$151.68	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-0260-03COLESTIPOL GRANULES	$54.74	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
00009-0260-17COLESTID 300GM GRANULES	$254.53	FSS	Pfizer Inc.	06/30/2029
00009-0260-17COLESTID 300GM GRANULES	$191.55	Big4	Pfizer Inc.	06/30/2029
00009-0260-02COLESTID 500GM GRANULES	$424.20	FSS	Pfizer Inc.	06/30/2029
00009-0260-02COLESTID 500GM GRANULES	$319.14	Big4	Pfizer Inc.	06/30/2029

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

Medicare Part D Spending

CMS annual spending data for Colestid (2024)

Total Spending

$41K

Total Claims

200

Beneficiaries

Avg Cost/Unit

$2.02

Spending Trend

$262K(2019)→$301K(2020)→$354K(2021)→$135K(2022)→$199K(2023)→$41K(2024)

YoY Change:-16.5%

5yr CAGR:-6.5%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

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
Apr 27, 2018	SUPPL -24	View Letter (PDF)
May 23, 2014	SUPPL -23	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#003 — 5GM/SCOOPFUL

RLD

0 patents0 exclusivities▾

GRANULE;ORAL | Approved: Sep 22, 1995

#004 — 5GM/PACKET

RLD

0 patents0 exclusivities▾

GRANULE;ORAL | Approved: Sep 22, 1995

#001 — 5GM/PACKET

RLD

0 patents0 exclusivities▴

GRANULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 5GM/SCOOPFUL

RLD

0 patents0 exclusivities▾

GRANULE;ORAL | Approved: Approved Prior to Jan 1, 1982