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Research and Markets: Generic Drug Opportunity Assessment - Ambrisanten (Letairis)
[January 23, 2014]

Research and Markets: Generic Drug Opportunity Assessment - Ambrisanten (Letairis)

DUBLIN --(Business Wire)--

Research and Markets ( has announced the addition of the "Generic Drug Opportunity Assessment - Ambrisanten (Letairis)" report to their offering.

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.

The Brand

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 (News - Alert) for Volibris in Europe.

The Drug

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 substantially higher.

The Opportunity

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.

Market Dynamics

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.

Report Highlights:

  • 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

For more information visit

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