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Tuesday, September 27, 2016
Dear Doctor, please provide with info about new medication pirfenidone (esbriet). FDA promised decision at May 4th. If it will be positive: is the drug will be available for prescription right away? When pharmacies will be ready to sell it for patients? Which one will be available:brand or generic version? I would appreciate the answers, thanks in advance.
At present, there has not been any public announcement by the company about availability if the drug is approved by the FDA in May. It is likely that it will take some time to ramp up drug production and distribution. There is also no word yet on pricing, but it will only be available in a brand-name formulation and not as a generic. Because the market for the drug will be relatively small (compared, for example, to the market for drugs to treat high blood pressure or diabetes which are much more common diseases than IPF), it is likely that pirfenidone will be relatively expensive. I am uncertain how much pirfenidone cost to develop, but it is estimated that the average new drug costs about $800 million for research and development before it is commercially available. The company will need to recoup these costs so the price of the drug will likely be rather high.
James N Allen, Jr, MD
Clinical Professor of Pulmonary, Allergy, Critical Care & Sleep Medicine
College of Medicine
The Ohio State University