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Last Updated: January 28, 2020

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IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for ibuprofen; pseudoephedrine hydrochloride and what is the scope of patent protection?

Ibuprofen; pseudoephedrine hydrochloride is the generic ingredient in six branded drugs marketed by Glaxosmithkline, Aurobindo Pharma Ltd, J And J Consumer Inc, Perrigo, Contract Pharmacal, Dr Reddys Labs Ltd, and Ohm Labs, and is included in ten NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ibuprofen; pseudoephedrine hydrochloride has fourteen patent family members in thirteen countries.

There are sixty-four drug master file entries for ibuprofen; pseudoephedrine hydrochloride. Nine suppliers are listed for this compound.

Recent Clinical Trials for IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

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SponsorPhase
Pharma Medica Research, Inc.Phase 1
Institut für Pharmakologie und Präventive MedizinPhase 1
Boehringer IngelheimPhase 1

See all IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials

Recent Litigation for IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

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District Court Litigation
Case NameDate
SCHERING CORPORATION v. SANDOZ INC.2008-04-03
Simonian v. Pfizer, Inc.
WYETH v. RANBAXY LABORATORIES LIMITED

See all IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE litigation

US Patents and Regulatory Information for IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Perrigo IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen; pseudoephedrine hydrochloride SUSPENSION;ORAL 076478-001 Nov 5, 2003 OTC No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline CHILDREN'S ADVIL COLD ibuprofen; pseudoephedrine hydrochloride SUSPENSION;ORAL 021373-001 Apr 18, 2002 OTC No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline ADVIL COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 019771-001 Sep 19, 1989 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen; pseudoephedrine hydrochloride CAPSULE;ORAL 209235-001 Dec 1, 2017 OTC No No   Start Trial   Start Trial   Start Trial
J And J Consumer Inc SINE-AID IB ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 019899-001 Dec 31, 1992 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 IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

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