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
International Patents: | 25 |
US Patents: | 5 |
Tradenames: | 4 |
Applicants: | 6 |
NDAs: | 6 |
Finished Product Suppliers / Packagers: | 12 |
Clinical Trials: | 6 |
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
Sponsor | Phase |
---|---|
Duke University | Phase 4 |
Horizon Pharma Ireland, Ltd., Dublin Ireland | Phase 4 |
Pediatric Rheumatology Collaborative Study Group | Phase 4 |
Pharmacology for famotidine; ibuprofen
Drug Class | Histamine-2 Receptor Antagonist Nonsteroidal Anti-inflammatory Drug |
Mechanism of Action | Cyclooxygenase Inhibitors Histamine H2 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for famotidine; ibuprofen
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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