FDA · United States
amoxicillin — FDA regulatory status
amoxicillin (ALPHAMOX 250) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- ALPHAMOX 250
- Originator
- Alphapharm Pty Ltd
- Mechanism
- Bacterial penicillin-binding protein inhibitor
- Target
- Bacterial penicillin-binding protein
- Structured fields
- 8
Sponsor / originator context: Alphapharm Pty Ltd. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Bacterial penicillin-binding protein inhibitor. Target: Bacterial penicillin-binding protein. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 53 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| 600 mg Ibuprofen | Phase 3 | United Therapeutics Europe | NCT07006675 |
| 9999 | Phase 3 | United Therapeutics Europe | NCT00396526 |
| APHP200011 | Phase 3 | PARItec | 2024-513327-16-00 |
| APHP220763 | Phase 3 | PARItec | 2024-514952-34-00 |
| APHP220814 | Phase 3 | PARItec | 2023-504208-27-00 |
| APHP230841 | Phase 3 | PARItec | 2025-520842-31-00 |
| APHP241013 | Phase 3 | PARItec | 2025-521571-30-00 |
| Amoxycillin | Phase 3 | United Therapeutics Europe | NCT00407394 |
| BEP(500) | Phase 3 | United Therapeutics Europe | NCT01726374 |
| Co-Trimoxazole 960Mg Dispersible Tablet | Phase 3 | United Therapeutics Europe | NCT04395365 |
| Generic Budesonide/Formoterol Fumarate Dihydrate | Phase 3 | Teva Pharma | NCT02495168 |
| Generic Estradiol Vaginal Cream USP, 0.01% | Phase 3 | Teva Pharma | NCT03294538 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 2026015039 | THÉRAPIE GÉNIQUE POUR LE TRAITEMENT DE L'ENCÉPHALOPATHIE ÉPILEPTIQUE ASSOCIÉE À LA SYNGAP1 | WO |
| 2025211975 | AGONISTES DU RÉCEPTEUR DE L'OREXINE | WO |
| 12076377 | Variant sulfatase enzymes with enhanced properties | US |
| 11931463 | All-in-one fixed-dose combination for treating Helicobacter pylori infection | US |
| 11878011 | Method for eradicating Helicobacter pylori infection in patients regardless of body mass index | US |
| 11154614 | Method for producing virus like particles | US |
| 11135172 | Rifabutin-based compositions and methods for treating Helicobacter pylori infection | US |
| 11028153 | Targeting immunological functions to the site of bacterial infections using cell wall targeting domains of bacteriolysins | US |
| 10487140 | Targeting immunological functions to the site of bacterial infections using cell wall targeting domains of bacteriolysins | US |
| 10238606 | Pharmaceutical compositions for the treatment of Helicobacter pylori | US |
| 10233450 | Methods and compositions for the specific inhibition of gene expression by double-stranded RNA | US |
| 10106792 | Methods and compositions for the specific inhibition of gene expression by double-stranded RNA | US |
Related hubs
FAQ
What is the FDA approval status of amoxicillin?
amoxicillin currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get amoxicillin regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to amoxicillin?
This spoke lists 53 published programs associated with amoxicillin in our pipeline index.