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Last Updated: March 19, 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 two branded drugs marketed by Horizon, Alkem Labs Ltd, Ascent Pharms Inc, and Teva Pharms Usa, and is included in four 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.

Eight 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
Teva Pharms Usa IBUPROFEN AND FAMOTIDINE famotidine; ibuprofen TABLET;ORAL 211278-001 Oct 29, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Ascent Pharms Inc IBUPROFEN AND FAMOTIDINE famotidine; ibuprofen TABLET;ORAL 216814-001 Mar 15, 2023 AB RX 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

International Patents for famotidine; ibuprofen

Country Patent Number Title Estimated Expiration
New Zealand 574200 METHODS AND MEDICAMENTS FOR ADMINISTRATION OF IBUPROFEN AND FAMOTIDINE ⤷  Try a Trial
China 101257800 Medicaments containing famotidine and ibuprofen and administration of same ⤷  Try a Trial
European Patent Office 2438919 Compositions contenant de l'ibuprofene et de la famotidine ainsi que des compositions contenant de 25 mg a 28 mg de la famotidine (Compositions comprising famotidine and ibuprofen as well as compositions comprising 25 mg to 28 mg famotidine) ⤷  Try a Trial
Canada 2657928 PROCEDES ET MEDICAMENTS DESTINES A L'ADMINISTRATION D'IBUPROFENE (METHODS AND MEDICAMENTS FOR ADMINISTRATION OF IBUPROFEN) ⤷  Try a Trial
Japan 2009501801 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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