Pipeline Database

UB280

Amoxicillin and Clavulanate Potassium Tablets

UB280

ProductAmoxicillin and Clavulanate Potassium Tablets

Strength0.25g: 0.125g

IndicationsUpper respiratory tract infection; Sinusitis; Tonsillitis; Pharyngitis; Lower respiratory tract infection; Bronchitis acute; Chronic bronchitis exacerbation; Pneumonia; Lung abscess; Urinary tract infection; Cystitis; Urethritis; Pyelonephritis; Prostatitis; Pelvic inflammatory disease; Gonococcal urethritis; Chancroid; Skin infection; Soft tissue infection; Furuncle; Abscess; Cellulitis; Wound infection; Intra-abdominal infection; Otitis media; Osteomyelitis; Sepsis; Peritonitis; Postoperative infection

TherapeuticsInfectious Diseases

GMPCN - NMPA

RegistrationChina

ModalitiesSmall Molecule

Exclusive Summary

- Patents expired globally with first generics in the 1990s, leaving no IP barriers and enabling fast distribution-led entry.
- Listed on the WHO Essential Medicines List and widely first-line in guidelines for sinusitis, animal/human bites, and odontogenic infections, ensuring steady demand.
- Addresses large bacterial infection burdens: ~150M UTIs/year, ~700M AOM episodes/year, and tens of millions of bite wounds, with 250/125 mg a common adult strength (TID).
- Despite many generics (20+ US ANDAs), differentiation is feasible via stability/packaging for hot–humid markets (Alu-Alu, Zone IVb 24–36-month shelf life) and strong regulatory dossiers.
- Compared with originator Augmentin, compliant generics typically deliver 40–80% cost savings, supporting tender wins and private-channel uptake in LMICs.

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