Research and Markets (http://www.researchandmarkets.com/research/xmh8p5/generic_drug)
has announced the addition of the "Generic
Drug Opportunity Assessment - Ambrisanten (Letairis)" report to
Ambrisentan (brand name Letairis) 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.
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 systm 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.
The Market 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
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.
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.
For more information visit http://www.researchandmarkets.com/research/xmh8p5/generic_drug
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