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

Generic Drug Opportunity Assessment : Asenapine (Saphris)

  • January 2014
  • Greystone Research Associates
Report ID: 1973865


Greystone Research 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

Asenapine (Saphris) is a psychotropic agent indicated for the treatment of psychological disorders, including schizophrenia and bipolar disorder. The drug is supplied as a sublingual tablet. The brand drug owner is Merck and Co. Merck acquired Saphris as part of its 2009 acquisition of Schering-Plough. Schering-Plough acquired the then-development stage drug via its acquisition of Organon Biosciences in 2007. In 2010, asenapine, sold under the brand name Sycrest, received marketing approval in the EU for the treatment of bipolar I disorder in adults. In 2010, Merck and H. Lundbeck A/S announced a worldwide commercialization agreement for Sycrest sublingual tablets (5 mg, 10 mg). Under the terms of the agreement, Lundbeck paid a fee and makes product supply payments in exchange for exclusive commercial rights to Sycrest in all markets outside the United States, China and Japan. Merck’s sales of Saphris were $166 million in 2012 and $120 million in 2011.

The Drug

Saphris currently competes in a global market valued at approximately $13 billion annually. This therapeutic market consists of about a dozen unique APIs that are supplied in a variety of dosage form, primarily oral tablets. Several sustained injectable drugs have entered the market in the past few years. These drugs are designed to reduce the dosing frequency as a way of improving compliance and safety for schizophrenic patients.

The Market

Schizophrenia occurs in 1 percent of the general population, but it occurs in 10 percent of people who have a first-degree relative with the disorder, such as a parent, brother, or sister. People who have second-degree relatives (aunts, uncles, grandparents, or cousins) with the disease also develop schizophrenia more often than the general population. The risk is highest for an identical twin of a person with schizophrenia. He or she has a 40 to 65 percent chance of developing the disorder.

Therapeutic Sector P (IV) Activity

Recent Paragraph (IV) activity in the psychotropic drug segment has been limited, reflecting the life cycle stage of important branded drugs in this space. We epect activity to increase beginning in 2015 as several branded drugs reach the stage where challenges from generic drug sector participants is likely.

The Opportunity

Saphris had global revenue of US $ 166 million in 2012. We are forecasting revenue of $245 million in 2015. The drug competes with more than twenty product (brand + generic), including Risperdal Consta (Alkermes); Invega Sustenna (Ortho-McNeil Janssen); and Zyprexa Relprevv (Eli Lilly). The current ‘best’ retail price for Saphris is $370 for a prescription of 30 10 mg orally disintegrating tablets. This equates to a one-month supply based upon drug label guidelines. The annual retail cost is $4,440.

Generic Revenue Opportunity

We are predicting that the ANDA first-filer entering the market in will capture of the total global market for asenapine drugs for the treatment of schizophrenia in calendar year. The majority of sales will come during the 180-day exclusivity period, at a price approximate- ly of the brand price.

Report Highlights

Saphris – The Brand
Asenapine – The Product
Asenapine – The Market
Asenapine – The Opportunity
Manufacturing and Sourcing
Saphris Patents and Exclusivity
Therapeutic Class P4 Certifications
Generic First-to-File 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

Mental Illness Drugs Markets in China

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

China’s demand for Mental Illness 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 ...

Global Antipsychotic Drugs Market 2017-2021

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

About Antipsychotic Drugs Antipsychotic drugs are also called as major tranquilizers or neuroleptics. These drugs are primarily used for the treatment of psychiatric disorders such as schizophrenia, hallucinations, ...

Global Schizophrenia Therapeutics Market 2017-2021

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

About Schizophrenia Therapeutics Schizophrenia is a chronic mental disorder that alters the perception, thinking, and social behavior of an individual. Individuals suffering from this disease face difficulty ...

Download Unlimited Documents from Trusted Public Sources

Antipsychotic Market in the UK

  • August 2017
  • Antipsychotic  

  • United Kingdom  

View report >

Opioid Market in Canada

  • August 2017
    20 pages
  • Opioid  

  • Canada  

View report >

Addictions Statistics in Denmark

  • August 2017
    6 pages
  • Addictions  

  • Denmark  

View report >

Antipsychotic Market

21 days ago

Therapy Market

2 months ago

Related Market Segments :



Reportlinker.com © Copyright 2017. All rights reserved.

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