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Last Updated: August 7, 2020

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Diphenhydramine hydrochloride; ibuprofen - Generic Drug Details

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What are the generic drug sources for diphenhydramine hydrochloride; ibuprofen and what is the scope of patent protection?

Diphenhydramine hydrochloride; ibuprofen is the generic ingredient in two branded drugs marketed by Glaxosmithkline, Aurobindo Pharma Ltd, Bionpharma Inc, and Strides Pharma, and is included in four 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. Fifteen suppliers are listed for this compound.

Summary for diphenhydramine hydrochloride; ibuprofen
International Patents:12
US Patents:2
Tradenames:2
Applicants:4
NDAs:4
Drug Master File Entries: 23
Suppliers / Packagers: 15
Clinical Trials: 9
DailyMed Link:diphenhydramine hydrochloride; ibuprofen at DailyMed
Recent Clinical Trials for diphenhydramine hydrochloride; ibuprofen

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Oregon Health and Science UniversityPhase 2/Phase 3
I-FlowN/A
Stamford Anesthesiology Services, PCN/A

See all diphenhydramine hydrochloride; ibuprofen clinical trials

Paragraph IV (Patent) Challenges for DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
Tradename Dosage Ingredient NDA Submissiondate
ADVIL PM CAPSULE;ORAL diphenhydramine hydrochloride; ibuprofen 021393 2016-02-16

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
Strides Pharma IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 200888-001 Mar 5, 2012 OTC No No   Start Trial   Start Trial   Start Trial
Bionpharma Inc IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 090397-001 Nov 22, 2010 OTC No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline ADVIL PM diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 021393-001 Dec 21, 2005 OTC Yes Yes   Start Trial   Start Trial Y   Start Trial
>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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Serving leading biopharmaceutical companies globally:

Merck
Harvard Business School
Boehringer Ingelheim
Mallinckrodt
Johnson and Johnson
Express Scripts

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