20 billion has been spent for generic research. Every year, about 30 new products are typically brought by Sun to the Indian market, 25 APIs including drug master files for US and Europe are scaled up and more than 30 ANDAs for the US are developed and filed for. 266 products have been approved by the USFDA for sale in the US and 135 filings await approval as of June 2012. Along with its subsidiaries, Sun Pharma, has four state-of-the-art research and development centres across the world with more than 800 scientists employed. R&D facilities are located in Vadodara (India), Mumbai (India), Haifa (Israel), Brampton (Canada) and New York
In March 2012, the Patent Controller granted a CL to NATCO Pharma to manufacture and market a cheaper generic version of Nexavar at around Rs. 8,800 per person per year. Bayer subsequently appealed against the grant before the Intellectual Property Appellate Board (IPAB) and later before the Bombay High
Current trends in generic drug business which are the eight significant acquitions in 2006 for example Dr Reddy’s Laboratories outbid Teva (world largest generics company) to acquire Betapharm (Germany 4th largest), Ranbaxy to acquire Terapia (Romania’s largest generics company),Hospira to acquire Mayne Pharma, Barr Pharmaceutical to acquire Pliva, Mylan Labs to acquire Matrix, Stada Arzneimittel to acquire Hemopharm, Actavis to acquire Sindan. Spiraling healthcare cost and the healthcare expenditure = 3.1 – 5.0% of the GDP in year 2006 (Medical Cost Reference Guide, 2006). Government reduces expenditure by substitution affordable generics with prescription drugs which are the fastest rising component of health care. Trend observed in US and Japan are increasing use of
B. Entry into new markets Through the Transaction, along with the emerging markets, Sun Pharma will also gain entry into Japan, a market with high growth potential and low penetration of generic drugs. C. Diversified and highly complementary product portfolio A combined Sun Pharma and Ranbaxy will have a diverse, highly complementary portfolio of specialty and generic products marketed globally, including 445 ANDAs. Additionally, the combination will create one of the leading dermatology platforms in the United States. Sun Pharma will also get access to Ranbaxy’s new product pipeline.
These provide additional details about the safety and efficacy profile of the new drug. There are extensive studies on different formulations of new drug, various amount of dosages, the duration of treatment if it interacts with other drugs and safety profile. Trials can be conducted in patients with new age groups, different races, and various other types of patients.An important aspect of this phase of trials is the detection of previously unknown or inadequately quantified adverse reactions and various related risk factors. Sometimes experimental versus observational nature of experiments are distinguished from each other by use of the term post-market surveillance for the later. References: 1.