JB Chemicals and Pharmaceuticals Ltd has filed a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for its patented Pharmaceutical Dental Formulation (PDF) for metronidazole bezoate, chlorhexidine gluconate and local anesthetic.
The anti-bacterial over the counter product is used in the treatment of oral dental gingivitis, a common bacterial disease. The application filed by way of the Patent Co-operation Treaty (PCT) route is having tenure of about 20 years.
The company officials said that by December 2003, the US FDA would approve the NDA. "The approval for launch will take few more years and we should be able to launch product by 2005 end, " said Dr. Milind Joshi, Corporate Manager, Regulatory Affairs and Quality Operations.
Although an exact size of the US dental market could not be given, the company officials however confirmed that the market is highly lucrative. "Dentistry is a highly lucrative market. Thanks to our patent term till 2020, we will be the only company exclusively marketing the product," said Dr. Joshi.
The patent filed being the PCT way, JB will be able to launch the product simultaneously in other markets also. "Simultaneous to the US launch, we will be launching the product in the Russian and other CIS countries. The company is exploring possibilities to launch PDF in other places also," he said.
In the meanwhile, JB Chemicals filed Abbreviated New Drug Application (ANDA) during December for Cipro (Ciprofloxacin). "All the formalities have been completed. We are so prepared that our shipments will begin the day after Bayer loses its patent in December 2003," he said. Cipro is currently having a US market size of $ 3 billion.
The company is also extremely ambitious about its results in the fields of New Drug Delivery System (NDDS) and New Chemical Entity (NCE) research. It has already earmarked Rs 50 crore in the next 2-5 years for its research activities.
The US and South African Patent Offices have granted patents for all the NCEs invented by JB's R&D department. The company has already forwarded similar application to European Union authorities for filing this patent.
JB Chemicals has also made progress on studies being carried out on twenty new chemical entities (NCEs) invented by the in-house R&D. The preliminary toxicology studies carried out on certain selected molecules have shown significant potent anti-inflammatory activity. Acute toxicity studies carried out on these selected molecules were found to be satisfactory in mice and rats.