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Last Updated: March 29, 2024

DIPHENHYDRAMINE CITRATE; IBUPROFEN - Generic Drug Details


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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 Haleon Us Holdings, Aurobindo Pharma, Dr Reddys Labs Ltd, and Perrigo R And D, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-seven suppliers are listed for this compound.

Summary for DIPHENHYDRAMINE CITRATE; IBUPROFEN
Recent Clinical Trials for DIPHENHYDRAMINE CITRATE; IBUPROFEN

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SponsorPhase
Dr. Reddy's Laboratories LimitedPhase 1

See all DIPHENHYDRAMINE CITRATE; IBUPROFEN clinical trials

Pharmacology for DIPHENHYDRAMINE CITRATE; IBUPROFEN
Paragraph IV (Patent) Challenges for DIPHENHYDRAMINE CITRATE; IBUPROFEN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ADVIL PM Tablets diphenhydramine citrate; ibuprofen 200 mg/38 mg 021394 1 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
Haleon Us Holdings ADVIL PM diphenhydramine citrate; ibuprofen TABLET;ORAL 021394-001 Dec 21, 2005 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Perrigo R And D IBUPROFEN AND DIPHENHYDRAMINE CITRATE diphenhydramine citrate; ibuprofen TABLET;ORAL 079113-001 Dec 22, 2008 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma IBUPROFEN AND DIPHENHYDRAMINE CITRATE diphenhydramine citrate; ibuprofen TABLET;ORAL 216204-001 May 31, 2022 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Ltd IBUPROFEN AND DIPHENHYDRAMINE CITRATE diphenhydramine citrate; ibuprofen TABLET;ORAL 090619-001 Jul 8, 2009 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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