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Last Updated: July 3, 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

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

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

See all pseudoephedrine hydrochloride clinical trials

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
Glaxosmithkline ACTIFED pseudoephedrine hydrochloride; triprolidine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018996-001 Jun 17, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Newtron Pharms TRILITRON pseudoephedrine hydrochloride; triprolidine hydrochloride TABLET;ORAL 088515-001 Jan 9, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
J And J Consumer Inc SUDAFED 24 HOUR pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 020021-002 Dec 15, 1992 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us NOVAFED pseudoephedrine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 017603-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd PSEUDOEPHEDRINE HYDROCHLORIDE pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209008-001 Jun 9, 2017 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:

Express Scripts
Harvard Business School
Moodys
McKinsey
Merck
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.