Last Updated: May 20, 2026

PSEUDOEPHEDRINE Drug Patent Profile


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When do Pseudoephedrine patents expire, and what generic alternatives are available?

Pseudoephedrine is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, L Perrigo Co, Sun Pharm Inds Ltd, Cent Pharms, Graham Dm, Kv Pharm, and Sandoz. and is included in nine NDAs.

The generic ingredient in PSEUDOEPHEDRINE is pseudoephedrine hydrochloride; triprolidine hydrochloride. There are forty-nine drug master file entries for this compound. Additional details are available on the pseudoephedrine hydrochloride; triprolidine hydrochloride profile page.

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Summary for PSEUDOEPHEDRINE

US Patents and Regulatory Information for PSEUDOEPHEDRINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma PSEUDOEPHEDRINE HYDROCHLORIDE pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209008-001 Jun 9, 2017 OTC No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Graham Dm PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE chlorpheniramine maleate; pseudoephedrine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018843-001 Mar 18, 1985 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
Kv Pharm PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE chlorpheniramine maleate; pseudoephedrine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 071455-001 Mar 1, 1989 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Aurobindo Pharma Ltd PSEUDOEPHEDRINE HYDROCHLORIDE pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 218854-001 Dec 29, 2025 OTC No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
L Perrigo Co PSEUDOEPHEDRINE HYDROCHLORIDE pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 075153-001 Feb 26, 1999 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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