UB281
ProductCefuroxime Axetil Tablets
Strength0.125g; 0.25g
IndicationsLower respiratory tract infection; Acute bronchitis; Acute exacerbation of chronic bronchitis; Pneumonia; Upper respiratory tract infection; Otitis media; Sinusitis; Tonsillitis; Pharyngitis; Genitourinary tract infection; Pyelonephritis; Cystitis; Urethritis; Skin infection; Soft tissue infection; Impetigo; Pyoderma; Rash pustular; Gonorrhoea; Gonococcal urethritis; Gonococcal cervicitis
TherapeuticsInfectious Diseases
GMPCN - NMPA
RegistrationChina
ModalitiesSmall Molecule
Exclusive Summary
- - Fully off-patent globally with >20 years of generic use; entry barrier is mainly bioequivalence and stability, enabling fast distribution partnerships.
- - Addresses high-burden RTIs, AOM, pharyngitis, SSTIs and UTIs with hundreds of millions of annual episodes, ensuring steady prescription demand.
- - Active against beta-lactamase–producing H. influenzae and Moraxella, positioned for first-line failure, non–type I penicillin allergy, and IV-to-oral step-down.
- - Highly genericized market; differentiate via fed-state BE, moisture-robust Alu-Alu packs, pediatric-friendly 125/250 mg strengths, and flexible pack sizes.
- - Delivers ~70–95% per-course cost savings vs originator, competitive for tenders and out-of-pocket private markets.
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