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Ibuprofen; pseudoephedrine hydrochloride - Generic Drug Details

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Ibuprofen; pseudoephedrine hydrochloride is the generic ingredient in six branded drugs marketed by J And J Consumer Inc, Dr Reddys Labs Ltd, Ohm Labs, Pfizer, Perrigo, and Contract Pharmacal, 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.

This ingredient has thirteen patent family members in twelve countries.

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

Summary for Generic Name: ibuprofen; pseudoephedrine hydrochloride

Tradenames:6
Patents:1
Applicants:6
NDAs:9
Drug Master File Entries: see list63
Suppliers / Packaging: see list30
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: ibuprofen; pseudoephedrine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Contract Pharmacal
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
ibuprofen; pseudoephedrine hydrochloride
TABLET;ORAL075588-001Apr 8, 2002OTCNo► subscribe► subscribe
Pfizer
ADVIL COLD AND SINUS
ibuprofen; pseudoephedrine hydrochloride
CAPSULE;ORAL021374-001May 30, 2002OTCYes► subscribe► subscribe
Dr Reddys Labs Ltd
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
ibuprofen; pseudoephedrine hydrochloride
TABLET;ORAL077628-001Aug 14, 2006OTCNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: ibuprofen; pseudoephedrine hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
ADVIL COLD AND SINUS
ibuprofen; pseudoephedrine hydrochloride
CAPSULE;ORAL021374-001May 30, 20025,071,643*PED► subscribe
Pfizer
ADVIL COLD AND SINUS
ibuprofen; pseudoephedrine hydrochloride
TABLET;ORAL019771-001Sep 19, 19894,552,899*PED► subscribe
Pfizer
ADVIL COLD AND SINUS
ibuprofen; pseudoephedrine hydrochloride
CAPSULE;ORAL021374-001May 30, 20025,360,615*PED► 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
Spain2397262► subscribe
South Korea20010007332► subscribe
European Patent Office1059084► 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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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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