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Last Updated: August 7, 2020

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PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for pseudoephedrine hydrochloride and what is the scope of patent protection?

Pseudoephedrine hydrochloride is the generic ingredient in sixteen branded drugs marketed by Sanofi Aventis Us, Glaxosmithkline, Aurobindo Pharma Ltd, L Perrigo Co, Sun Pharm Inds Ltd, Mcneil Cons, J And J Consumer Inc, Kv Pharm, Cenci, Usl Pharma, Newtron Pharms, Pvt Form, Fosun Pharma, Sandoz, Teva, Watson Labs, West Ward, Ivax Sub Teva Pharms, and Superpharm, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are forty-nine drug master file entries for pseudoephedrine hydrochloride. Thirty-one suppliers are listed for this compound.

Drug Sales Revenue Trends for PSEUDOEPHEDRINE HYDROCHLORIDE

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Recent Clinical Trials for PSEUDOEPHEDRINE HYDROCHLORIDE

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SponsorPhase
University of Maryland, BaltimoreN/A
CelgenePhase 1
BayerPhase 1

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US Patents and Regulatory Information for PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fosun Pharma CORPHED pseudoephedrine hydrochloride; triprolidine hydrochloride TABLET;ORAL 088602-001 Apr 11, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs TRIPROLIDINE AND PSEUDOEPHEDRINE pseudoephedrine hydrochloride; triprolidine hydrochloride TABLET;ORAL 088318-002 Jan 13, 1984 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Ltd PSEUDOEPHEDRINE HYDROCHLORIDE pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 077442-001 Sep 28, 2005 OTC No No   Start Trial   Start Trial   Start 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 PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc SUDAFED 24 HOUR pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020021-002 Dec 15, 1992   Start Trial   Start Trial
J And J Consumer Inc SUDAFED 24 HOUR pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020021-002 Dec 15, 1992   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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Dow
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