Famotidine; ibuprofen - Generic Drug Details
✉ Email this page to a colleague
What are the generic 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
International Patents: | 25 |
US Patents: | 5 |
Tradenames: | 2 |
Applicants: | 4 |
NDAs: | 4 |
Finished Product Suppliers / Packagers: | 8 |
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 |
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 | DISCN | Yes | No | ⤷ 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 | |||
Alkem Labs Ltd | IBUPROFEN AND FAMOTIDINE | famotidine; ibuprofen | TABLET;ORAL | 211890-001 | Aug 3, 2021 | AB | RX | No | Yes | ⤷ 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 |
---|---|---|---|
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 | |
Austria | E539747 | ⤷ 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 |
>Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.