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Last Updated: November 21, 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.

Eleven 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
Pediatric Rheumatology Collaborative Study GroupPhase 4
Horizon Pharma Ireland, Ltd., Dublin IrelandPhase 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
Teva Pharms Usa IBUPROFEN AND FAMOTIDINE famotidine; ibuprofen TABLET;ORAL 211278-001 Oct 29, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ascent Pharms Inc IBUPROFEN AND FAMOTIDINE famotidine; ibuprofen TABLET;ORAL 216814-001 Mar 15, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Torrent FAMOTIDINE AND IBUPROFEN famotidine; ibuprofen TABLET;ORAL 215925-001 Mar 18, 2024 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  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 ⤷  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
China 101257800 Medicaments containing famotidine and ibuprofen and administration of same ⤷  Sign Up
Canada 2615496 MEDICAMENTS CONTENANT FAMOTIDINE ET IBUPROFENE, ET ADMINISTRATION DESDITS MEDICAMENTS (MEDICAMENTS CONTAINING FAMOTIDINE AND IBUPROFEN AND ADMINISTRATION OF SAME) ⤷  Sign Up
Canada 2657928 PROCEDES ET MEDICAMENTS DESTINES A L'ADMINISTRATION D'IBUPROFENE (METHODS AND MEDICAMENTS FOR ADMINISTRATION OF IBUPROFEN) ⤷  Sign Up
Australia 2006269894 Medicaments containing famotidine and ibuprofen and administration of same ⤷  Sign Up
Spain 2380747 ⤷  Sign Up
Australia 2007275360 Methods and medicaments for administration of ibuprofen ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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