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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Chinese Patent Office
Farmers Insurance
Express Scripts
AstraZeneca
Citi
Merck
Accenture
Healthtrust

Generated: May 24, 2018

DrugPatentWatch Database Preview

Diphenhydramine hydrochloride; ibuprofen - Generic Drug Details

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What are the generic sources for diphenhydramine hydrochloride; ibuprofen and what is the scope of diphenhydramine hydrochloride; ibuprofen freedom to operate?

Diphenhydramine hydrochloride; ibuprofen
is the generic ingredient in two branded drugs marketed by Pfizer, Bionpharma Inc, and Strides Pharma, and is included in three NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Diphenhydramine hydrochloride; ibuprofen has twelve patent family members in ten countries.

There are twenty-three drug master file entries for diphenhydramine hydrochloride; ibuprofen. Sixteen suppliers are listed for this compound.
Summary for diphenhydramine hydrochloride; ibuprofen
International Patents:12
US Patents:2
Tradenames:2
Applicants:3
NDAs:3
Drug Master File Entries: 23
Suppliers / Packagers: 16
Clinical Trials: 688
DailyMed Link:diphenhydramine hydrochloride; ibuprofen at DailyMed

US Patents and Regulatory Information for diphenhydramine hydrochloride; ibuprofen

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer ADVIL PM diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 021393-001 Dec 21, 2005 OTC Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Strides Pharma IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 200888-001 Mar 5, 2012 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bionpharma Inc IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 090397-001 Nov 22, 2010 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pfizer ADVIL PM diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 021393-001 Dec 21, 2005 OTC Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for diphenhydramine hydrochloride; 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
8,263,647 Treatment of sleep disturbances ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Covington
Express Scripts
Citi
UBS
Johnson and Johnson
US Army
Queensland Health
QuintilesIMS

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