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Amherst, NH, United States, 2013/12/02 - Generic drugs are having a disruptive influence on the drug industry and the way brand drug developers patent and market their products - Symporia.com.
Often, the accidental timing of expiring patent and exclusivity protection for branded drugs in a particular therapeutic segment occur within a relatively compressed time period. The result can be a concentrated and accelerated transformation of the segment from one dominated by high-priced brand drugs to one populated by numerous generic products and suppliers, at least until the next-generation brand drug with improved outcomes and lower side effects is introduced into the market.
Pulmonary arterial hypertension (PAH) is continuous high blood pressure in the pulmonary artery. The average blood pressure in a normal pulmonary artery is about 14 mm/Hg when the person is resting. In PAH, the average is usually greater than 25 mm/Hg. There are two types of PAH. Primary pulmonary arterial hypertension (PPAH) is inherited or occurs for no known reason. Secondary pulmonary arterial hypertension (SPAH) either is caused by or occurs because of another condition. The conditions include chronic heart or lung disease, blood clots in the lungs, or a disease like scleroderma. About 300 new cases of PPAH are diagnosed in the United States each year. SPAH is much more common.
Treatments for PAH consist of FDA approved drugs delivered orally, by inhalation and by injection. Oral solid dosage (OSD) forms had global sales of slightly less than $3 billion in 2012. This total is comprised of four branded OSD drugs. Of these four, Revatio lost patent protection in late 2012. Tracleer, the leading drug in this class in terms of revenue, will lose patent protection in 2015. Letairis, the newest of the OSD drugs indicated for PAH, will lose FDA exclusivity and the majority of its patent protection by 2015.
The flurry of activity surrounding Pfizer’s Revatio is a harbinger of things to come. Five generics have entered the market in the past eighteen months. As a result of this generic competition, Revatio revenue will decline 75% this year. Generic activity will further accelerate with the loss of patent protection for Tracleer, the market segment leader, in late 2015. Tracleer’s revenue exceeded $1.6 billion in 2012. Letairis, the third brand of oral solid dosage drug for treating PAH, will loss a significant level of competitive protection by 2015 when several patents are set to expire. A successful P (iv) challenge could and likely will result in a first-to-file generic version of Letairis being launched by 2016.
The net result of generic activity in the PAH therapeutic drug segment will be a drop in total global revenue for all solid dosage forms of 50% from 2014 to 2018, even while total prescriptions will rise by 4.5% per year.
About Symporia Bioscience
Symporia Bioscience (symporia.com) analyzes generic drug markets, publishing generic drug First-to-File Opportunity Assessments, which are designed to allow industry managers to understand and evaluate the market potential for selected branded drugs from the viewpoint of creating and refining FDA ANDA regulatory filings in pursuit of first-filer generic drug applications. By applying predictive analytics to known drug market data, generic drug first-to-file opportunity assessments provide a unique view into the evolving generics drug sector. The publications represent detailed assessments of selected branded drugs in several important areas. The resulting conclusions are contained in written reports that are structured to provide timely insight to market participants.