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Last Updated: August 19, 2022

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 fifteen drug master file entries for pseudoephedrine hydrochloride. Thirty-two suppliers are listed for this compound.

Summary for pseudoephedrine hydrochloride
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, BaltimorePhase 4
Eli Lilly and CompanyN/A
CelgenePhase 1

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Pharmacology for pseudoephedrine hydrochloride

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
Ivax Sub Teva Pharms TRIPROLIDINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE pseudoephedrine hydrochloride; triprolidine hydrochloride TABLET;ORAL 085273-001 Dec 12, 1984 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cenci HISTAFED pseudoephedrine hydrochloride; triprolidine hydrochloride SYRUP;ORAL 088283-001 Apr 20, 1984 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Newtron Pharms TRILITRON pseudoephedrine hydrochloride; triprolidine hydrochloride SYRUP;ORAL 088474-001 Feb 12, 1985 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
West Ward TRIPROLIDINE AND PSEUDOEPHEDRINE pseudoephedrine hydrochloride; triprolidine hydrochloride TABLET;ORAL 088117-001 Apr 19, 1983 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Superpharm TRIPROLIDINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE pseudoephedrine hydrochloride; triprolidine hydrochloride TABLET;ORAL 088578-001 Feb 21, 1985 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Glaxosmithkline ACTIFED pseudoephedrine hydrochloride; triprolidine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018996-001 Jun 17, 1985 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
J And J Consumer Inc SUDAFED 24 HOUR pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020021-002 Dec 15, 1992 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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