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The FDA has given the green light to a conveniently priced leukemia drug, in a decision that gives renewed hope to cancer patients across the United States.
Sun Pharmaceutical Industries Limited, a Mumbai-based pharmaceutical company considered to be the most successful across the Indian subcontinent, will be the one making this treatment available, through one of its subsidiaries.
The company had submitted an Abbreviated New Drug Application (ANDA), which was eventually accepted by the U.S. Food and Drug Administration.
Thanks to this permit, it will be possible to manufacture and commercialize a much cheaper version of the Gleevec drug, which is currently being produced by pharmaceutical giant Novartis, headquartered in Basel, Switzerland.
Given the fact that Sun Pharma has also received paragraph IV patent certification from the FDA, it will be able to sell its generic equivalent of the branded medicine for 6 months, without having other competitors challenging this patent in order to release their own version of Gleevec.
The newly approved cancer treatment, known as Imatinib Mesylate will be available in two different dosages (100 milligrams or 400 milligrams), and will come at a much more convenient price tag than that of its predecessor.
This generic alternative is just as effective against blood and bone marrow disease, being able to turn it into a manageable condition, which no longer comes with an inescapable death warrant.
It is expected that American patients suffering from chronic myeloid leukemia, acute lymphoblastic leukemia and other similar cancer types will be able to purchase Imatinib Mesylate tablets, to be administered once a day, starting from February 1, 2016.
Nowadays, Gleevec tablets, which have been approved for commercialization back in 2001, generate annual sales for Novartis amounting to around $2.5 billion in the United States only, given the fact that treatment for just one blood cancer sufferer costs up to $10,000 per month.
Therefore, following the launch of this much awaited, cheaper replacement for the extremely cost-prohibitive Gleevec drug, financial analysts such as Sarabjit Kour Nangra, VP at Angel Broking, estimate that Sun Pharmaceutical will be supplementing its revenues by as much as $250 to 300 million.
Net profits are predicted to reach about $75 to $90 million, especially given the fact that the subsidiary will benefit from exclusivity in manufacturing and marketing this treatment option for a period of 180 days.
Meanwhile, Novartis will probably attempt to maintain its market share by issuing discount cards for leukemia patients who wish to keep buying the original drug.
Basically, individuals will only have to pay around $120 per year in order to benefit from their usual Gleevec medication, while the drug manufacturer will cover $30,000 of the costs, leaving the rest of the sum to be provided by private insurance companies.
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