➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Medtronic
Moodys
McKesson
Johnson and Johnson
McKinsey
Merck

Last Updated: August 7, 2020

DrugPatentWatch Database Preview

DIPHENHYDRAMINE CITRATE; IBUPROFEN - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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

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

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

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

Summary for DIPHENHYDRAMINE CITRATE; IBUPROFEN
International Patents:12
US Patents:1
Tradenames:2
Applicants:3
NDAs:3
Drug Master File Entries: 23
Suppliers / Packagers: 31
Clinical Trials: 2
DailyMed Link:DIPHENHYDRAMINE CITRATE; IBUPROFEN at DailyMed
Recent Clinical Trials for DIPHENHYDRAMINE CITRATE; IBUPROFEN

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

SponsorPhase
Dr. Reddy's Laboratories LimitedPhase 1

See all DIPHENHYDRAMINE CITRATE; IBUPROFEN clinical trials

Paragraph IV (Patent) Challenges for DIPHENHYDRAMINE CITRATE; IBUPROFEN
Tradename Dosage Ingredient NDA Submissiondate
ADVIL PM TABLET;ORAL diphenhydramine citrate; ibuprofen 021394 2017-12-28

US Patents and Regulatory Information for DIPHENHYDRAMINE CITRATE; IBUPROFEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Ltd IBUPROFEN AND DIPHENHYDRAMINE CITRATE diphenhydramine citrate; ibuprofen TABLET;ORAL 090619-001 Jul 8, 2009 OTC No No   Start Trial   Start Trial   Start Trial
Perrigo R And D IBUPROFEN AND DIPHENHYDRAMINE CITRATE diphenhydramine citrate; ibuprofen TABLET;ORAL 079113-001 Dec 22, 2008 OTC No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline ADVIL PM diphenhydramine citrate; ibuprofen TABLET;ORAL 021394-001 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
Johnson and Johnson
Moodys
AstraZeneca
Mallinckrodt
Dow

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 verification 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.