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Shire's (SHPG) Vyvanse U.S. Patent Validated, Expiry in 2023

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Shire plcSHPG announced that the Court of Appeals of the Federal Circuit (CAFC) has affirmed a ruling by the U.S. District Court for the District of New Jersey regarding the validity of patents protecting the active ingredient in Shire's top-selling drug, Vyvanse.

According to the CAFC's ruling, patents covering Vyvanse are valid. The CAFC's decision will prevent generic companies from launching their generic versions of Vyvanse for attention deficit hyperactivity disorder (ADHD) until the expiry of the patents in 2023.

Vyvanse is approved for the treatment of ADHD in patients aged 6 years and above and moderate-to-severe binge eating disorder in adults.

We remind investors that since 2011, Shire has been occupied with a consolidated patent infringement lawsuit in the U.S. District Court for the District of New Jersey against five companies - Sandoz, Inc. (Novartis' NVS generic arm), Amneal Pharmaceuticals, Roxane Laboratories, Inc., Mylan Pharmaceuticals, Inc. MYL , and Allergan AGN (name changed from Actavis plc to Allergan plc following the acquisition of Allergan in Mar 2015).

In Jun 2014, the U.S. District Court for the District of New Jersey had granted a ruling in favor of Shire's motion over 18 patent claims covering Vyvanse's active ingredient, which the company had alleged were valid and infringed by the abbreviated new drug applications (ANDAs) of the five companies. However, all the ANDA-defendants appealed against the U.S. District Court's summary judgment in CAFC.

We note that Vyvanse is a growth driver in Shire's portfolio. In the first six months of 2015, it generated revenues of $841.6 million, up 18% from the year-ago period, and accounted for 27.6% of total revenues. Sooner-than-expected entry of generic versions of the drug would have been a setback for the company.

Shire carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Corcept Therapeutics Incorporated CORT , carrying a Zacks Rank #1 (Strong Buy).

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ALLERGAN PLC (AGN): Free Stock Analysis Report

NOVARTIS AG-ADR (NVS): Free Stock Analysis Report

MYLAN NV (MYL): Free Stock Analysis Report

SHIRE PLC-ADR (SHPG): Free Stock Analysis Report

CORCEPT THERAPT (CORT): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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