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Last Updated: May 31, 2023

Chlorpheniramine maleate - Generic Drug Details


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What are the generic drug sources for chlorpheniramine maleate and what is the scope of patent protection?

Chlorpheniramine maleate is the generic ingredient in twenty-three branded drugs marketed by Aurolife Pharma Llc, Glaxosmithkline, Schering Plough, Bel Mar, Elkins Sinn, Watson Labs, Schering, Pharm Assoc, Bayer Healthcare Llc, Avanthi Inc, Alza, Bayer Pharms, Anabolic, Bell Pharma, Impax Labs, Ivax Sub Teva Pharms, Kv Pharm, Lederle, Newtron Pharms, Panray, Pharmavite, Pharmeral, Pioneer Pharms, Purepac Pharm, Pvt Form, Roxane, Sun Pharm Industries, Vitarine, West Ward, Halsey, Lannett, Mainpointe, Acella, Tris Pharma Inc, Persion, Mayne Pharma Inc, Padagis Us, Torrent, Graham Dm, Novartis, Schwarz Pharma, Fisons, and Cent Pharms, and is included in sixty-two NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for chlorpheniramine maleate. Two suppliers are listed for this compound.

Drug Prices for chlorpheniramine maleate

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Drug Sales Revenue Trends for chlorpheniramine maleate

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Recent Clinical Trials for chlorpheniramine maleate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Dr. Ferrer BioPharmaPhase 2/Phase 3
Hospital CEMESA Cort├ęs, San Pedro Sula, HondurasPhase 2/Phase 3
Marcos Sanchez-Gonzalez, MD, PhDPhase 2/Phase 3

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Pharmacology for chlorpheniramine maleate
Medical Subject Heading (MeSH) Categories for chlorpheniramine maleate

US Patents and Regulatory Information for chlorpheniramine maleate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Healthcare Llc CHLOR-TRIMETON chlorpheniramine maleate; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 018397-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Torrent HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride SOLUTION;ORAL 206660-001 May 15, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs CHLORPHENIRAMINE MALEATE chlorpheniramine maleate TABLET;ORAL 080791-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ivax Sub Teva Pharms CHLORPHENIRAMINE MALEATE chlorpheniramine maleate TABLET;ORAL 080779-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Graham Dm COLD CAPSULE IV chlorpheniramine maleate; phenylpropanolamine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018793-001 Apr 25, 1985 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline ADVIL ALLERGY AND CONGESTION RELIEF chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride TABLET;ORAL 022113-001 Dec 21, 2011 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lederle CHLORPHENIRAMINE MALEATE chlorpheniramine maleate TABLET;ORAL 086941-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for chlorpheniramine maleate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alza EFIDAC 24 CHLORPHENIRAMINE MALEATE chlorpheniramine maleate TABLET, EXTENDED RELEASE;ORAL 019746-002 Nov 18, 1994 ⤷  Try a Trial ⤷  Try a Trial
Alza EFIDAC 24 CHLORPHENIRAMINE MALEATE chlorpheniramine maleate TABLET, EXTENDED RELEASE;ORAL 019746-002 Nov 18, 1994 ⤷  Try a Trial ⤷  Try a Trial
Alza EFIDAC 24 CHLORPHENIRAMINE MALEATE chlorpheniramine maleate TABLET, EXTENDED RELEASE;ORAL 019746-002 Nov 18, 1994 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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