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Famotidine; ibuprofenis the generic ingredient in two branded drugs marketed by Horizon and Alkem Labs Ltd, and is included in two NDAs. There are six 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.
There are eighteen drug master file entries for famotidine; ibuprofen. Two suppliers are listed for this compound.
Summary for famotidine; ibuprofen
|Drug Master File Entries:||18|
|Finished Product Suppliers / Packagers:||2|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for famotidine; ibuprofen|
|DailyMed Link:||famotidine; ibuprofen at DailyMed|
Recent Clinical Trials for famotidine; ibuprofen
Identify potential brand extensions & 505(b)(2) entrants
|Duke University||Phase 4|
|Pediatric Rheumatology Collaborative Study Group||Phase 4|
|Horizon Pharma Ireland, Ltd., Dublin Ireland||Phase 4|
Pharmacology for famotidine; ibuprofen
|Drug Class||Nonsteroidal Anti-inflammatory Drug |
Histamine-2 Receptor Antagonist
|Mechanism of Action||Cyclooxygenase Inhibitors |
Histamine H2 Receptor Antagonists
Anatomical Therapeutic Chemical (ATC) Classes 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||AB||RX||Yes||Yes||⤷ Try it Free||⤷ Try it Free||⤷ Try it Free|
|Horizon||DUEXIS||famotidine; ibuprofen||TABLET;ORAL||022519-001||Apr 23, 2011||AB||RX||Yes||Yes||⤷ Try it Free||⤷ Try it Free||Y||⤷ Try it Free|
|Alkem Labs Ltd||IBUPROFEN AND FAMOTIDINE||famotidine; ibuprofen||TABLET;ORAL||211890-001||Aug 3, 2021||AB||RX||No||No||⤷ Try it Free||⤷ Try it Free||⤷ Try it Free|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
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