1. Market Research
  2. > Pharmaceutical
  3. > Therapy Market Trends

Generic Drug Opportunity Assessment : Ambrisanten (Letairis)

  • January 2014
  • Greystone Research Associates
Report ID: 1973863


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.

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 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 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.

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.

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.

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.

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.

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

Get Industry Insights. Simply.

  • Latest reports & slideshows with insights from top research analysts
  • 60 Million searchable statistics with tables, figures & datasets
  • More than 25,000 trusted sources
  • Single User License — provides access to the report by one individual.
  • Department License — allows you to share the report with up to 5 users
  • Site License — allows the report to be shared amongst all employees in a defined country
  • Corporate License — allows for complete access, globally.

Veronica helps you find the right report:


The research specialist advised us on the best content for our needs and provided a great report and follow-up, thanks very much we shall look at ReportLinker in the future.

Kate Merrick

Global Marketing Manager at
Eurotherm by Schneider Electric

We were impressed with the support that ReportLinker’s research specialists’ team provided. The report we purchased was useful and provided exactly what we want.

Category Manager at

ReportLinker gave access to reliable and useful data while avoiding dispersing resources and spending too much time on unnecessary research.

Executive Director at
PwC Advisory

The customer service was fast, responsive, and 100% professional in all my dealings (...) If we have more research needs, I'll certainly prioritize working with ReportLinker!

Scott Griffith

Vice President Marketing at
Maurice Sporting Goods

The research specialist provided prompt, helpful instructions for accessing ReportLinker's product. He also followed up to make sure everything went smoothly and to ensure an easy transition to the next stage of my research

Jessica P Huffman

Research Associate at
American Transportation Research Institute

Excellent customer service. Very responsive and fast.

Director, Corporate Strategy at

I reached out to ReportLinker for a detailed market study on the Air Treatment industry. The quality of the report, the research specialist’s willingness to solve my queries exceeded my expectations. I would definitely recommend ReportLinker for in-depth industry information.

Mariana Mendoza

Global Platform Senior Manager at
Whirlpool Corporation

Thanks! I like what you've provided and will certainly come back if I need to do further research works.

Bee Hin Png

CEO at
LDR Pte Ltd

The research specialist advised us on the best content for our needs and provided a great report and follow-up, thanks very much we shall look at ReportLinker in the future.

Kate Merrick

Global Marketing Manager at
Eurotherm by Schneider Electric

Purchase Reports From Reputable Market Research Publishers

Hypertension Drugs Markets in China

  • $ 4000
  • Industry report
  • May 2017
  • by Asia Market Information & Development Company

China’s demand for Hypertension Drugs has grown at a fast pace in the past decade. In the next decade, both production and demand will continue to grow. The Chinese economy maintains a high speed growth ...

Global Acute Ischemic Stroke Therapeutics Market 2017-2021

  • $ 3500
  • Industry report
  • August 2017
  • by Infiniti Research Limited

About Acute Ischemic Stroke Therapeutics AIS is a chronic condition characterized by the sudden loss of blood supply to a part of the brain, thus causing subsequent loss of neurological function. AIS is ...

Asperger Syndrome Global Clinical Trials Review, H1, 2017

  • $ 2500
  • Industry report
  • April 2017
  • by GlobalData

Asperger Syndrome Global Clinical Trials Review, H1, 2017 Summary GlobalData’s clinical trial report, “Asperger Syndrome Global Clinical Trials Review, H1, 2017" provides an overview of Asperger Syndrome ...

Download Unlimited Documents from Trusted Public Sources

Therapy Market in the US

  • August 2017
    11 pages
  • Therapy  

  • United States  

    United Kingdom  

View report >

Cardiovascular Drug Market in India

  • July 2017
    9 pages
  • Cardiovascular ...  

  • India  

View report >

Therapy Market in Europe - Forecast

  • July 2017
    12 pages
  • Therapy  

  • Europe  

    United States  

View report >


Reportlinker.com © Copyright 2017. All rights reserved.

ReportLinker simplifies how Analysts and Decision Makers get industry data for their business.