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AMPICILLIN SODIUM
Ampicillin Sodium is a marketed antibiotic primarily indicated for skin and skin structure infections. The drug holds a key composition patent expiring in 2028, providing a period of exclusivity and potential market protection. The primary risk is the lack of revenue data, which limits the ability to assess its current market performance and financial impact.
At a glance
| Generic name | AMPICILLIN SODIUM |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1971 |
Approved indications
- Skin and Skin Structure Infections
- Intra-Abdominal Infections
- Gynecological Infections
Common side effects
- Pain at IM injection site
- Pain at IV injection site
- Thrombophlebitis
- Phlebitis
- Diarrhea
- Rash
Drug interactions
- probenecid
- allopurinol
- aminoglycosides
Key clinical trials
- APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis) (PHASE2)
- Tegoprazan-Based Therapies for H. Pylori Eradication: A Randomized Controlled Trial (NA)
- Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics (PHASE4)
- Early Versus Late Stopping of Antibiotics in Children With Cancer and High-risk Febrile Neutropenia (PHASE4)
- A Randomised Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients. (PHASE4)
- Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial (PHASE2)
- Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing (PHASE2)
- Subcutaneous Piperacillin/Tazobactam Compared With Intravenous Treatment (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- AMPICILLIN SODIUM CI brief — competitive landscape report
- AMPICILLIN SODIUM updates RSS · CI watch RSS