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Diphenhydramine citrate; ibuprofen - Generic Drug Details

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Diphenhydramine citrate; ibuprofen is the generic ingredient in two branded drugs marketed by Perrigo R And D, Dr Reddys Labs Ltd, and Pfizer, and is included in three NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has eleven patent family members in ten countries.

There are twenty-three drug master file entries for diphenhydramine citrate; ibuprofen. Thirty-eight suppliers are listed for this compound.

Summary for Generic Name: diphenhydramine citrate; ibuprofen

Tradenames:2
Patents:1
Applicants:3
NDAs:3
Drug Master File Entries: see list23
Suppliers / Packaging: see list38
Formulation / Manufacturing:see details
Drug Prices:see low prices
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer
ADVIL PM
diphenhydramine citrate; ibuprofen
TABLET;ORAL021394-001Dec 21, 2005OTCYes8,263,647► subscribeY ► subscribe
Dr Reddys Labs Ltd
IBUPROFEN AND DIPHENHYDRAMINE CITRATE
diphenhydramine citrate; ibuprofen
TABLET;ORAL090619-001Jul 8, 2009OTCNo► subscribe► subscribe
Perrigo R And D
IBUPROFEN AND DIPHENHYDRAMINE CITRATE
diphenhydramine citrate; ibuprofen
TABLET;ORAL079113-001Dec 22, 2008OTCNo► subscribe► subscribe
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Non-Orange Book Patents for Generic Ingredient: diphenhydramine citrate; ibuprofen

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
8,883,849Treatment of sleep disturbances► subscribe
9,155,718Treatment of sleep disturbances► 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: diphenhydramine citrate; ibuprofen

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)02056877► subscribe
European Patent Office1363608► subscribe
Germany60207383► 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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