Viewing data from:

CHLOR-TRIMETON

NDA

CHLORPHENIRAMINE MALEATE | N007638 | BAYER HEALTHCARE LLC

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 (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Avanthi, LLC. FDA-2018-P-3691 · 5 docket documents Avanthi, LLC filed this citizen petition requesting that the FDA determine whether Chlor-Trimeton (Chlorpheniramine Maleate) Extended Release Tablet 8 mg, NDA 007638 held by Bayer Healthcare LLC, was voluntarily withdrawn from the market for safety or effectiveness reasons under 21 CFR 314.161, as t	505(q)	2018-09-28	Granted	Avanthi, LLC.
Pharma Medica - Citizen Petition FDA-2009-P-0320 · 2 docket documents Pharma Medica submitted a citizen petition under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare sustained release tablets containing Chlorpheniramine maleate 8 mg and Pseudoephedrine Hydrochloride 120 mg suitable for marketing pending ANDA approval, and reque	Other	2009-07-16	Open	—

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

Clinical Trials

12 trials from ClinicalTrials.gov, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Anti-histamines Promote Electroacupuncture Analgesia: Basic and Clinical Research NCT03805035	N/A	Completed	China Medical University Hospital	40	2019-01-24 → 2019-06-30
Fed Study of Chlorpheniramine Polistirex and Hydrocodone Polistirex Capsules and Tussionex® Pennkinetic® Extended Release Oral Suspension NCT00853190	Phase 1	Completed	Mallinckrodt	43	2003-09 → 2003-10
Fasting Study of Chlorpheniramine Polistirex and Hydrocodone Polistirex Capsules and Tussionex® Pennkinetic® Extended Release Oral Suspension NCT00853294	Phase 1	Completed	Mallinckrodt	42	2003-09 → 2003-09
Dose-Ranging Study of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (C95-161)NCT03879772	Phase 3	Completed	Organon and Co	679	1996-03-12 → 1996-07-01
Effect of Anti-histamine in Prevention Systolic Hypotension After Protamine NCT03583567	Phase 4	Completed	Mahidol University	40	2018-09-05 → 2019-03-31
Study Evaluating Chlorpheniramine Maleate Liquid in Children and Adolescents NCT00837837	Phase 1	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	36	2008-12-21 → 2009-02-02
Exploratory Study for Allergy Relief Onset NCT02722083	Phase 2	Terminated	Bayer	1	2016-05-07 → 2016-07-13
A Multicenter Study to Determine the Depth and Duration of Hepatitis B Surface Antigen (HBsAg) Reduction After Single or Multiple Doses of ARC-520, in Combination With Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection NCT02065336	Phase 2	Terminated	Arrowhead Pharmaceuticals	58	2014-03 → 2017-01
Clinical Trial of the Safety and Efficacy of SP160412 in the Temporary Relief of Mild to Moderate Sunburn NCT03332524	Phase 2	Terminated	Sephoris Pharmaceuticals LLC	80	2018-01-15 → 2019-09-25
Effect of the Antihistamine Injection to Prevent Paradoxical Reaction During Sedative Endoscopy NCT03940391	N/A	UNKNOWN	Seoul National University Hospital	220	2019-05-01 → 2020-04-14

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

API Supply Chain4 active DMFs8 inactive

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

KONGO CHEMICAL CO LTDCHLORPHENIRAMINE MALEATE USP

DMF 38851980

KESHAVA ORGANICS PVT LTDCHLORPHENIRAMINE MALEATE

DMF 213562008

SUPRIYA LIFESCIENCE LTDCHLORPHENIRAMINE MALEATE USP

DMF 222102008

MALLADI DRUGS AND PHARMACEUTICALS LTDCHLORPHENIRAMINE MALEATE

DMF 339442019

KV PHARMACEUTICAL COInactiveCHLORPHENIRAMINE MALEATE 12 MG SRC

DMF 22781974

SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORPInactiveCHLORPHENIRAMINE MALEATE

DMF 39351980

SCHERING PLOUGH AVONDALE COInactiveCHLORPHENIRAMINE MALEATE

DMF 43051981

SANDOZ PHARM CORPInactiveCHLORPHENIRAMINE MALEATE

DMF 53861984

FUKUZYU PHARMACEUTICAL CO LTDInactiveCHLORPHENIRAMINE MALEATE

DMF 60331985

HEXAGON LABORATORIES INCInactiveCHLORPHENIRAMINE MALEATE USP

DMF 63051986

PENCO OF LYNDHURST INCInactiveCHLORPHENIRAMINE MALEATE

DMF 78791989

GRANULES INDIA LTDInactiveChlorpheniramine Maleate USP

DMF 210032007

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Dec 29, 2015	SUPPL -38	View Letter (PDF)
Feb 7, 2008	SUPPL -33	View Letter (PDF)
Jan 30, 2006	SUPPL -32	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Approved Prior to Jan 1, 1982