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Last Updated: November 28, 2021

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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.

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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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
L Perrigo Co PSEUDOEPHEDRINE HYDROCHLORIDE pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 075153-001 Feb 26, 1999 OTC No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Watson Labs TRIPROLIDINE AND PSEUDOEPHEDRINE pseudoephedrine hydrochloride; triprolidine hydrochloride TABLET;ORAL 088318-002 Jan 13, 1984 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Glaxosmithkline ACTIFED pseudoephedrine hydrochloride; triprolidine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018996-001 Jun 17, 1985 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Fosun Pharma CORPHED pseudoephedrine hydrochloride; triprolidine hydrochloride TABLET;ORAL 088602-001 Apr 11, 1985 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Aurobindo Pharma Ltd PSEUDOEPHEDRINE HYDROCHLORIDE pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209008-001 Jun 9, 2017 OTC No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Cenci ACTAHIST pseudoephedrine hydrochloride; triprolidine hydrochloride SYRUP;ORAL 088344-001 Feb 9, 1984 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 ⤷  Free Forever Trial ⤷  Free Forever Trial
J And J Consumer Inc SUDAFED 24 HOUR pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020021-002 Dec 15, 1992 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
McKesson
Dow
Merck
Moodys
Mallinckrodt

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