Viewing data from:

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

4 petitions (4 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
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	Open	Hyman
Suitability Petition from Hyman, Phelps & McNamara P.C. FDA-2021-P-0513 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	Open	Hyman
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	Open	Hyman
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	Open	Hyman

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Colestid (2023)

Total Spending

$199K

Total Claims

835

Beneficiaries

438

Avg Cost/Unit

$2.43

Spending Trend

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

YoY Change:-18.8%

5yr CAGR:-9.4%

Source: CMS Medicare Part D Spending by Drug (2023). 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

Change History (2)

Recent changes detected for this application.

MODIFIEDTE Code7/1/2026

Flavored Colestid (colestipol hydrochloride) therapeutic equivalence code changed from AB to a different rating.

Old: AB

MODIFIEDTE Code7/1/2026

Flavored Colestid (colestipol hydrochloride) therapeutic equivalence code changed from AB to a new classification.

Old: AB