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Last Updated: October 11, 2024

Famotidine; ibuprofen - Generic Drug Details


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

Famotidine; ibuprofen is the generic ingredient in four branded drugs marketed by Horizon, Torrent, Endo Operations, Alkem Labs Ltd, Ascent Pharms Inc, and Teva Pharms Usa, and is included in six NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Famotidine; ibuprofen has twenty-five patent family members in fifteen countries.

Twelve suppliers are listed for this compound.

Summary for famotidine; ibuprofen
Recent Clinical Trials for famotidine; ibuprofen

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

SponsorPhase
Duke UniversityPhase 4
Horizon Pharma Ireland, Ltd., Dublin IrelandPhase 4
Pediatric Rheumatology Collaborative Study GroupPhase 4

See all famotidine; ibuprofen clinical trials

Paragraph IV (Patent) Challenges for FAMOTIDINE; IBUPROFEN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DUEXIS Tablets famotidine; ibuprofen 800 mg/26.6 mg 022519 1 2011-12-06

US Patents and Regulatory Information for famotidine; ibuprofen

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Alkem Labs Ltd IBUPROFEN AND FAMOTIDINE famotidine; ibuprofen TABLET;ORAL 211890-001 Aug 3, 2021 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for famotidine; ibuprofen

Country Patent Number Title Estimated Expiration
Denmark 2043637 ⤷  Sign Up
European Patent Office 1919288 MEDICAMENTS CONTENANT FAMOTIDINE ET IBUPROFENE, ET ADMINISTRATION DESDITS MEDICAMENTS (MEDICAMENTS CONTAINING FAMOTIDINE AND IBUPROFEN AND ADMINISTRATION OF SAME) ⤷  Sign Up
Brazil PI0714937 forma de dosagem unitÁria oral, e, uso de uma forma de dosagem unitÁria ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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