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Generated: December 14, 2017

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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 ibuprofen; pseudoephedrine hydrochloride patent protection?

Ibuprofen; pseudoephedrine hydrochloride
is the generic ingredient in six branded drugs marketed by Pfizer, J And J Consumer Inc, Perrigo, Contract Pharmacal, Dr Reddys Labs Ltd, and Ohm Labs, and is included in nine 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. Twenty suppliers are listed for this compound.

Summary for ibuprofen; pseudoephedrine hydrochloride

Pharmacology for ibuprofen; pseudoephedrine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
J And J Consumer IncCHILDREN'S MOTRIN COLDibuprofen; pseudoephedrine hydrochlorideSUSPENSION;ORAL021128-001Aug 1, 2000OTCYesYes► Subscribe► Subscribe► Subscribe► Subscribe
PerrigoIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEibuprofen; pseudoephedrine hydrochlorideSUSPENSION;ORAL076478-001Nov 5, 2003OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Ohm LabsIBUPROHM COLD AND SINUSibuprofen; pseudoephedrine hydrochlorideTABLET;ORAL074567-001Apr 17, 2001OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Dr Reddys Labs LtdIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEibuprofen; pseudoephedrine hydrochlorideTABLET;ORAL077628-001Aug 14, 2006OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
PfizerADVIL COLD AND SINUSibuprofen; pseudoephedrine hydrochlorideTABLET;ORAL019771-001Sep 19, 1989OTCYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Contract PharmacalIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEibuprofen; pseudoephedrine hydrochlorideTABLET;ORAL075588-001Apr 8, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
J And J Consumer IncSINE-AID IBibuprofen; pseudoephedrine hydrochlorideTABLET;ORAL019899-001Dec 31, 1992OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
PfizerCHILDREN'S ADVIL COLDibuprofen; pseudoephedrine hydrochlorideSUSPENSION;ORAL021373-001Apr 18, 2002OTCNoNo► Subscribe► Subscribe► Subscribe► Subscribe
PfizerADVIL COLD AND SINUSibuprofen; pseudoephedrine hydrochlorideCAPSULE;ORAL021374-001May 30, 2002OTCYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ibuprofen; pseudoephedrine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
PfizerADVIL COLD AND SINUSibuprofen; pseudoephedrine hydrochlorideCAPSULE;ORAL021374-001May 30, 2002► Subscribe► Subscribe
PfizerADVIL COLD AND SINUSibuprofen; pseudoephedrine hydrochlorideTABLET;ORAL019771-001Sep 19, 1989► Subscribe► Subscribe
PfizerADVIL COLD AND SINUSibuprofen; pseudoephedrine hydrochlorideCAPSULE;ORAL021374-001May 30, 2002► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: ibuprofen; pseudoephedrine hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,060,730Rapidly absorbed liquid compositions► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: ibuprofen; pseudoephedrine hydrochloride

Country Document Number Estimated Expiration
Japan2001019638► Subscribe
South Korea20010007332► Subscribe
Brazil0002607► Subscribe
Canada2311039► Subscribe
European Patent Office1059084► Subscribe
South Africa200002892► Subscribe
Colombia5160329► Subscribe
China1151784► Subscribe
China1277841► Subscribe
New Zealand504944► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Cipla
Chinese Patent Office
Federal Trade Commission
Julphar
Daiichi Sankyo
Boehringer Ingelheim
Cerilliant
AstraZeneca
Accenture
Johnson and Johnson

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 verifification 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.

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