Research and Markets: Generic Drug Opportunity Assessment - Asenapine (Saphris)

DUBLIN--()--Research and Markets (http://www.researchandmarkets.com/research/fhq2c2/generic_drug) has announced the addition of the "Generic Drug Opportunity Assessment - Asenapine (Saphris)" report to their offering.

Asenapine (Saphris) 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.

This psychotropic agent is 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.

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.

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

For more information visit http://www.researchandmarkets.com/research/fhq2c2/generic_drug

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Contacts

Research and Markets
Laura Wood, Senior Manager.
press@researchandmarkets.com
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector: Pharmaceuticals, Generics

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Contacts

Research and Markets
Laura Wood, Senior Manager.
press@researchandmarkets.com
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector: Pharmaceuticals, Generics