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Last Updated: August 7, 2020

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SUDAFED 12 HOUR Drug Profile

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When do Sudafed 12 Hour patents expire, and what generic alternatives are available?

Sudafed 12 Hour is a drug marketed by Glaxosmithkline and Mcneil Cons and is included in two NDAs.

The generic ingredient in SUDAFED 12 HOUR is pseudoephedrine hydrochloride. There are forty-nine drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the pseudoephedrine hydrochloride profile page.

Summary for SUDAFED 12 HOUR
Drug patent expirations by year for SUDAFED 12 HOUR
Recent Clinical Trials for SUDAFED 12 HOUR

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SponsorPhase
National Heart, Lung, and Blood Institute (NHLBI)Phase 0
Vanderbilt UniversityPhase 0
National Center for Advancing Translational Science (NCATS)Phase 0

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US Patents and Regulatory Information for SUDAFED 12 HOUR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline SUDAFED 12 HOUR pseudoephedrine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 017941-002 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Mcneil Cons SUDAFED 12 HOUR pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 073585-001 Oct 31, 1991 OTC No Yes   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

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McKesson
Merck

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