FAMOTIDINE; IBUPROFEN Drug Patent Profile
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When do Famotidine; Ibuprofen patents expire, and when can generic versions of Famotidine; Ibuprofen launch?
Famotidine; Ibuprofen is a drug marketed by Endo Operations and is included in one NDA.
The generic ingredient in FAMOTIDINE; IBUPROFEN is famotidine; ibuprofen. There are eighteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the famotidine; ibuprofen profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Famotidine; Ibuprofen
A generic version of FAMOTIDINE; IBUPROFEN was approved as famotidine; ibuprofen by ENDO OPERATIONS on March 22nd, 2024.
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Summary for FAMOTIDINE; IBUPROFEN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| 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 |
| Pediatric Rheumatology Collaborative Study Group | Phase 4 |
| Horizon Pharma Ireland, Ltd., Dublin Ireland | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Endo Operations | FAMOTIDINE; IBUPROFEN | famotidine; ibuprofen | TABLET;ORAL | 203658-001 | Mar 22, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
