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Last Updated: March 28, 2024

FAMOTIDINE; IBUPROFEN - Generic Drug Details


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What are the generic sources for famotidine; ibuprofen and what is the scope of freedom to operate?

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
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
Alkem Labs Ltd IBUPROFEN AND FAMOTIDINE famotidine; ibuprofen TABLET;ORAL 211890-001 Aug 3, 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 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 ⤷  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
>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
Portugal 2043637 ⤷  Try a Trial
Japan 2009543885 ⤷  Try a Trial
New Zealand 574200 METHODS AND MEDICAMENTS FOR ADMINISTRATION OF IBUPROFEN AND FAMOTIDINE ⤷  Try a Trial
Israel 188732 שימוש באיבופרופין ופאמוטידין להכנת תרופות (Use of ibuprofen and famotidine in the preparation of medicaments) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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