Research and Markets: Generic Drug Opportunity Assessment - Granisetron Sancuso

Research and Markets (http://www.researchandmarkets.com/research/zsf99g/generic_drug) has announced the addition of the "Generic Drug Opportunity Assessment - Granisetron Sancuso" report to their offering.

Sancuso (Granisetron Transdermal System) 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.

It is supplied as a 52 cm2 patch containing 34.3 mg of granisetron. Sancuso contains granisetron, which is an antiemetic agent. Chemically, Granisetron is a selective 5-hydroxytryptamine3 (5-HT3) receptor antagonist. Serotonin receptors of the 5-HT3 type are located peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. During chemotherapy that induces vomiting, mucosal enterochromaffin cells release serotonin, which stimulates 5-HT3 receptors. This evokes vagal afferent discharge, inducing vomiting.

The Drug

Sancuso was developed in-house by ProStrakan, Prostrakan is a subsidiary of Kyowa Hakko Kirin Co. Ltd., and is marketed by ProStrakans own sales force in the U.S., UK, France, Germany, Spain, Italy and other EU countries. The company will also make Sancuso available for outlicensing in EU countries in which it does not have a sales presence.

The Opportunity

Because of the high level of competition in the market segment for treating chemotherapy induced nausea and vomiting, we expect a steep decline in the brand price for Sancuso once the first-filer generic drug product enters the market. We expect first year price erosion for the brand of more than 50%, resulting in a significant and dramatic decline in revenue for the brand holder (ProStrakan). We are forecasting first-filer market share on a global prescription basis in excess of 30% during the first year of market entry.

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/zsf99g/generic_drug

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Sector: Pharmaceuticals, Generics