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QUESTRAN LIGHT

NDA

CHOLESTYRAMINE | N019669 | BRISTOL MYERS CO

2 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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Bristol-Myers FDA-1987-P-0130 · 5 docket documents Bristol-Myers filed this citizen petition in September 1987 requesting that the FDA determine an Abbreviated New Drug Application is suitable for a cholestyramine tablet containing 1.0 g per tablet, which would provide a more convenient alternative to the existing Questran Powder formulation while m	Other	2017-05-16	Granted	Bristol-Myers
Bristol-Myers Squibb Company - Citizen Petition FDA-1993-P-0328 · 4 docket documents Bristol-Myers Squibb Company filed this citizen petition under section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA rescind the July 15, 1993 Interim Guidance on cholestyramine powder in vitro bioequivalence and refuse to approve any cholestyramine applications relying	505(q)	2010-11-02	Denied	—

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

Clinical Trials

20 trials from ClinicalTrials.gov, 18 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Low Doses of Cholestyramine in the Treatment of Hyperthyroidism NCT00677469	N/A	Completed	Shiraz University of Medical Sciences	45	2007-07 → 2008-01
PRELIMINARY EVALUATION OF PHARMACOLOGICAL LOWERING OF AGEs NCT02249897	Phase 4	Completed	University of Chile	7	2015-01 → 2017-12
An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia NCT03510884	Phase 3	Completed	Sanofi	153	2018-05-31 → 2022-08-05
Post Coronary Artery Bypass Graft (CABG) Study NCT00000463	Phase 3	Completed	National Heart, Lung, and Blood Institute (NHLBI)	—	1987-04 → 1998-12
Pharmacokinetic and Tolerability Study of 14 mg Single Dose of Teriflunomide in Subjects With Severe Renal Impairment NCT01239459	Phase 1	Completed	Sanofi	16	2010-11 → 2011-03
Harvard Atherosclerosis Reversibility Project (HARP)NCT00000461	Phase 2	Completed	National Heart, Lung, and Blood Institute (NHLBI)	—	1986-12 → 1992-11
Efficacy and Safety of Elobixibat in Combination With Cholestyramine for Nonalcoholic Fatty Liver Disease NCT04235205	Phase 2	Completed	Yokohama City University	102	2020-01-29 → 2021-09-30
NHLBI Type II Coronary Intervention Study NCT00000594	Phase 3	Completed	National Heart, Lung, and Blood Institute (NHLBI)	—	1971-11 → 1976-11
An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia NCT02890992	Phase 2	Completed	Sanofi	42	2016-09-15 → 2019-02-22
A Study to Evaluate the Pharmacokinetic Profiles of Single 14 mg Teriflunomide Tablet in Healthy Chinese Volunteers NCT02046629	Phase 1	Completed	Sanofi	12	2014-05 → 2014-07

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

API Supply Chain3 active DMFs2 inactive

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

PUROLITE LLCCHOLESTYRAMINE RESIN USP

DMF 73241988

ION EXCHANGE INDIA LTDCHOLESTYRAMINE RESIN USP (INDION 454)

DMF 231712009

PHAEX POLYMERS PRIVATE LTDCHOLESTYRAMINE RESIN USP AS IN

DMF 276072013

DOW CHEMICAL COInactiveCHOLESTYRAMINE USP

DMF 57591985

ROHM AND HAAS COInactiveCHOLESTYRAMINE RESIN, USP-AMBERLITE IRP-276

DMF 65061986

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

Products (2)

Sort:

#001 — EQ 4GM RESIN/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

POWDER;ORAL | Approved: Dec 5, 1988

No patent or exclusivity listings for this strength.

#003 — EQ 4GM RESIN/SCOOPFUL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

POWDER;ORAL | Approved: Dec 5, 1988