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Last Updated: May 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. Additional information is available in the individual branded drug profile pages.

There are sixty-four drug master file entries for ibuprofen; pseudoephedrine hydrochloride. Ten 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
PATHEON SOFTGELS INC. v. PURACAP PHARMACEUTICAL LLC2018-10-05
RECKITT BENCKISER LLC v. AMNEAL PHARMACEUTICALS LLC2015-03-26
SCHERING CORPORATION v. SANDOZ INC.2008-04-03

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
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
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 CAPSULE;ORAL 021374-001 May 30, 2002 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc CHILDREN'S MOTRIN COLD ibuprofen; pseudoephedrine hydrochloride SUSPENSION;ORAL 021128-001 Aug 1, 2000   Start Trial   Start Trial
Glaxosmithkline ADVIL COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride CAPSULE;ORAL 021374-001 May 30, 2002   Start Trial   Start Trial
Glaxosmithkline ADVIL COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 019771-001 Sep 19, 1989   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:

Harvard Business School
McKesson
Medtronic
Merck
Baxter
AstraZeneca

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.