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Last Updated: July 13, 2020

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IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug 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. Additional information is available in the individual branded drug profile pages.

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

Summary for IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Recent Clinical Trials for IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

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

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

See all IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials

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
Ohm Labs IBUPROHM COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 074567-001 Apr 17, 2001 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
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
Contract Pharmacal IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 075588-001 Apr 8, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 077628-001 Aug 14, 2006 OTC No No   Start Trial   Start Trial   Start Trial
Perrigo IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen; pseudoephedrine hydrochloride SUSPENSION;ORAL 076478-001 Nov 5, 2003 OTC No No   Start Trial   Start Trial   Start Trial
J And J Consumer Inc CHILDREN'S MOTRIN COLD ibuprofen; pseudoephedrine hydrochloride SUSPENSION;ORAL 021128-001 Aug 1, 2000 OTC Yes 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

Expired US Patents for IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

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Serving leading biopharmaceutical companies globally:

Dow
McKesson
Colorcon
Medtronic
Baxter
Merck

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