Levofloxacin Opportunities for Generic Launch

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GenericsWeb analyses Levofloxacin and its surrounding patent landscape, highlighting the need for comprehensive, up-to-date information in the development of launch strategies that minimise the cost of litigation and understanding the barriers to launch as to receive the benefits of your generic product being first to market.

GenericsWeb, a leader in established pharmaceutical patent searching and analysis, recently published an article based on its proprietary patent intelligence for the antibacterial drug Levofloxacin. The article analyses the surrounding patent landscape, highlighting the need for comprehensive, up-to-date information in the development of launch strategies that minimise the cost of litigation and understanding the barriers to launch as to receive the benefits of your generic product being first to market.

Key findings of the article include:

# The Australian and Canadian members of the patent family protecting the active enantiomer (molecule) expired in June 2006 and 2009 respectively. The remaining members of the family protecting major territories are due to expire in June 2011 as a result of patent term extensions or SPCs, with the exception of the Spanish equivalent, which is not due to expire until June 2012.

# Daiichi Sankyo have been extremely active when it comes to protecting their product from generic competition, and have taken legal action in a number of countries against different companies attempting to launch generic Levofloxacin products. In the United States, after successfully defending several Paragraph IV challenges to the enforceability of molecule patent US5053407 ('407), Ortho-McNeil recently won an injunction to prevent Lupin from infringement during the extended term for this patent, which is assigned to Daiichi Sankyo but exclusively licensed to Ortho-McNeil.

# As a result of Daiichi Sankyo's very active and successful history of protecting their molecule patent, it will be difficult for a company to safely launch generic Levofloxacin prior to expiration of the term extension. However, following the expiry of the patents protecting the molecule, evidence suggests that Levofloxacin will face substantial generic competition for all dosage forms except the oral solution leaving a question over Daichii Sankyo’s effectiveness in managing the lifecycle of this product
Levofloxacin is a synthetic broad-spectrum antibacterial agent which is a member of the fluoroquinolone drug class. It is the pure (-)-(S)-enantiomer of Ofloxacin, and was first patented by Daiichi Sankyo. In 1993, Daiichi Sankyo entered into a licensing agreement with Sanofi-Aventis, where it was marketed and sold under the tradename Tavanic. Later licensing agreements with companies such as Ortho-McNeil and Johnson & Johnson (J&J) resulted in Levofloxacin being available in over 120 countries worldwide, where it is sold under the tradename Levaquin. Levaquin generated US$1.6 billion in worldwide sales for J&J alone in 2009.
You can read the entire article here at http://www.genericsweb.com/druginfocus/Levofloxacin

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PIPELINE DEVELOPER
Pipeline Developer is a professional patent database providing the very best in comprehensive patent information while minimising the risk of wasted developments or legal action. Searched and analysed by highly trained, dedicated staff using sophisticated searching techniques, Pipeline Developer delivers results you can rely on through a convenient online interface. For more information on Pipeline Developer visit http://www.genericsweb.com.

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Yoann Bretonnet
GenericsWeb
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