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Greystone Research Associates has identified a branded drug that represents an attractive opportunity for generic drug companies that utilize the provisions under Section 505(j)(2)(A)(vii)(IV) as part of their ANDA-filing strategy. Details of our findings are contained in an insightful assessment, the highlights if which are presented below.
Ambrisentan (brand name Letairis) is a endothelin receptor antagonist indicated for treating pulmonary arterial hypertension (PAH) (WHO Group 1) in patients with WHO Class II or III symptoms.. The brand drug owner is Gilead Science. The rights to the product are partially sublicensed to GlaxoSmithKline, which markets anbrisentan as Volibris, for PAH in territories outside of the United States. In 2008, Glaxo received marketing authorization from the EMA for Volibris in Europe.
Endothelin receptor antagonists inhibit the binding of endothelin, a vasoconstrictive peptide, to its receptors on smooth muscle cells which results in vasodilation. The activation of the endothelin system plays a critical role in chronic cardiovascular diseases, such as pulmonary hypertension, and in acute cardiovascular conditions, such as right heart failure and cerebral vasospasm, a constriction of blood vessels in the brain following subarachnoid hemorrhage. It is also implicated in connective tissue diseases such as scleroderma and pulmonary fibrosis.
Pulmonary arterial hypertension (PAH) is a rare, progressive disease characterized by high blood pressure in the arteries that funnel blood from the heart to the lungs. Although Pulmonary arterial hypertension is a rare disease, with an estimated prevalence of 15-50 cases per million, the prevalence of PAH in certain at-risk groups is substantially higher.
With patents expiring for two of the top three drug brands having recently expired or expiring in the near future, generic drugs are set to have a significant impact on the therapeutic market for PAH. The patents for Letairis are not held by Gilead but are held by third parties. Gilead acquired the exclusive rights to the applicable patents in the agreements executed with these third parties. Letairis has been granted exclusivity by the FDA under exclusivity code ODE (Orphan Drug Exclusivity). This exclusivity expires on June 15, 2014.
Therapeutic Sector P (IV) Activity
The antihypertensive segment of the cardiovascular drug sector has been quite active, with P (IV) certifications averaging about four per year since 2004. This trend reflects the continuing healthcare challenges associated with hypertension as well as the fragmented therapeutic environment. We expect this trend to continue through 2017, as brand drugs lose exclusivity and patent protection.
In terms of the overall market for PAH therapeutics, we expect the dominant position of oral solid dosage forms to diminish on a total revenue basis as current and forecast future early generic drug market entries put pressure on average dosage form drug pricing. The net effect will reduce total oral solid dosage form revenue as a percent of total segment revenue from 76% in 2012 to 52% in 2018.
Generic Revenue Opportunity
We are predicting that the ANDA first-filer entering the market in will capture of the total global market for abrisanten drugs for the treatment of PAH in calendar year . The majority of sales will come during the 180-day exclusivity period, at a price approximately of the brand price.
Letairis – The Brand
Ambrisentan – The Drug
Ambrisentan – The Market
Ambrisentan – The Opportunity
Ambrisentan Patents and Exclusivity
Therapeutic Class P4 Certifications
Generic Revenue Opportunity
Business Risk Assessment
First-to-File – Probabilistic Scenario
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