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Last Updated: November 21, 2024

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 Haleon Us Holdings, Aurobindo Pharma Ltd, Bionpharma, and Strides Pharma, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Seventeen suppliers are listed for this compound.

Recent Clinical Trials for DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

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

SponsorPhase
Guangzhou Kangqi Medical Technology Co., LTDPhase 1
Overseas Pharmaceuticals, Ltd.Phase 1
HALEONPhase 1

See all DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN clinical trials

Pharmacology for DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
Paragraph IV (Patent) Challenges for DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ADVIL PM Capsules diphenhydramine hydrochloride; ibuprofen 200 mg/25 mg 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
Aurobindo Pharma Ltd IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 210676-001 Feb 14, 2019 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bionpharma IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 090397-001 Nov 22, 2010 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  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
Haleon Us Holdings 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

Expired US Patents for DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Haleon Us Holdings ADVIL PM diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 021393-001 Dec 21, 2005 ⤷  Sign Up ⤷  Sign Up
Haleon Us Holdings ADVIL PM diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 021393-001 Dec 21, 2005 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 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.