Venus Remedies has received product patent by Intellectual Property Office (IPO), Government of India for Sulbactomax, out of is patent basket of 341 patents filed globally. Sulbactomax is a fixed dose combination of a beta lactam antibiotic ceftriaxone sodium and a beta lactamase inhibitor sulbactam sodium in dry powder form for injection to be used after reconstitution with a super solvent. Product is used for combating betalactamase mediated antibiotic resistance of existing ceftriaxone molecule with the aid of betalactamase inhibitor.
Venus filed this patent in 2004 and launched this product after a lot of research efforts, going through all schedule Y requirements and DCGI approval after acute/sub-acute toxicity studies, multi centric phase III clinical trials. The company also conducted phase IV to establish safety and efficacy of this new product. Currently one more clinical trial is going on for this product with additional indications.
Sulbactomax is one of the most potent combination, highly effective against betalactamase producing cephalosporin resistant pathogenic bacteria like K pneumoniae, E.coli etc. The product is indicated for lower respiratory tract infections, pre and post operative infections, skin and skin structure infections, urinary tract infections, acute bacterial otitis media and other infections caused by betalactamse producing ceftriaxone resistant bacteria.
The company is marketing this product in India and 7 other countries. Further, registration is in process in another 10 countries in different continents world wide. The company is in the advanced stage of filing Common Technical Document (CTD) for this product in Europe & with registration of CTD dossier European market shall be open for Sulbactomax. This product was out-licensed to a leading Korean company last year with exclusive marketing rights. Venus has filled patent for this product in another 50 countries including US, Europe, Australia, Japan and LA countries. It received patent from South Africa and it is planning to enter in SA market through CTD route.
Current global cephalosporin market is US$ 9.62 billion, out of this market size for ceftriaxone is $1.2 billion with $105 million in Indian Sub-continent alone. Ceftriaxone market is facing degrowth due to development of resistance world over. Subactomax, an innovative product of Venus is capable of replacing a larger share of ceftriaxone market by providing a cutting edge to the chronic extended spectrum beta lactamases (ESBL) problem.