Indian pharmaceutical industry will now be able to make further inroads and garner a fair share of the global market opportunity as blockbuster drugs valued at $170 billion are set to come off the patents.
From garnering the much-required revenues, to spurring drug research and increase job openings, the patent expiry phase will now enable Indian pharma on an upward trajectory, noted industry experts.
“Losing patent rights due to expiry of term obviously is a financial loss for any pharmaceutical company. But at the same time, this opens a window for generic drug manufacturers, especially in the developing countries to manufacture and offer drugs at affordable price,” said Bindu Sharma, Founder & CEO, Origiin IP Solutions LLP.
The World Generic Medicines Congress Europe 2015 indicates that drugs valued at $170 billion in annual sales will lose patents in 2015, leaving concerned companies trying to calculate the imminent damage. Aripiprazole by Otsuka Pharmaceuticals , glatirame by Teva Pharma, albuterol-ipratropium inhalation by Boehringer Ingelheim, imatinib mesylate by Novartis, memantine HCI by Forrest Labs, etc are some of the off-patent drugs. These drugs treat conditions like neuro-psychiatry, Multiple Sclerosis, cancer, Alzheimer’s, sleep disorders, COPD, anti viral and HIV.
The Indian pharma garners much of its revenues from exports. Now companies including Sun, Dr. Reddy’s Labs, Glenmark, Cipla, Lupin, Torrent, etc will be able to grab the business opportunity from global markets. In the US alone the post patent cliff, demand for generic is expected to be at 86-87% .
“There are around five Indian companies in the list of top 20 global generic companies,” said Sudhanshu Pandey, joint secretary, Department of Commerce, Government of India at a Pharmexcil event.
According to Sunil Attavar, secretary, Karnataka Drugs and Pharmaceutical Manufacturers Association, the patent expiry drugs are a massive opportunity for Indian pharma. All big players in the country have been extremely proactive and well prepared by lining up their pipeline to propel growth.
Concurring similar views was Dr. Prakash Mallya, director, Academic Studies, Krupanidhi College of Pharmacy who estimated over 100 Indian companies geared up for the generic rush and the big advantage is all these were armed with global regulatory approvals. These companies will now further expand presence in the US which is biggest in terms of value and volume for generics.
“The promising market opportunity needs ample long-term planning and research efforts. Indian pharma companies would have made efforts to timely file the ANDAs”, said Kaushik Desai, pharma consultant, Hon General Secretary, Indian Pharmaceutical Association and Chairperson, Industrial Pharmacy Section, Federation of Asian Pharmaceutical Associations (FAPA).
The off-patent drugs also provides room for alternative growth paths as indicated by World Generic Medicines Congress Europe 2015. Indian pharma will need to fast track orphan drugs, work on new drug delivery devices and develop drugs with different forms of the new molecule, pointed out Desai.