Appeals Court Affirms Shire’s Vyvanse® (lisdexamfetamine dimesylate) Patents Are Valid Until 2023
Ruling bars generic versions of Vyvanse from entering market until patents expire
Lexington, Mass. – September 24, 2015 – Shire plc (LSE: SHP, NASDAQ: SHPG) announces today that the Court of Appeals of the Federal Circuit has upheld the summary judgment ruling of the U.S. District Court for the District of New Jersey that certain claims of the patents protecting Vyvanse® (lisdexamfetamine dimesylate) are valid.
Shire’s lawsuit included all of the known pharmaceutical manufacturers that filed Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration (FDA) seeking to market generic versions of Vyvanse, along with their Active Pharmaceutical Ingredient (API) manufacturer of lisdexamfetamine dimesylate API. The ANDA-defendants are Actavis LLC/Actavis Elizabeth LLC; Amneal Pharmaceuticals, LLC; Mylan Pharmaceuticals Inc./Mylan Inc.; Roxane Laboratories Inc.; and Sandoz Inc. The API manufacturer and supplier to each of the ANDA-defendants is Johnson Matthey Inc./Johnson Matthey Pharmaceutical Materials.
The ruling prevents the ANDA defendants from launching generic versions of Vyvanse until the expiration of these patents in 2023. The defendants may move for rehearing at the Federal Circuit, or may file a petition at the U.S. Supreme Court.
“We are extremely pleased that the Federal Circuit affirmed the District Court’s ruling that the patents are valid, which further confirms that Shire has strong patents protecting Vyvanse,” said Mark Enyedy, Interim General Counsel, Shire.
The Court of Appeals of the Federal Circuit affirmed the District Court’s summary judgment ruling that 18 patent claims from four of the FDA Orange Book-listed patents for Vyvanse are valid. The ANDA defendants’ infringement of these claims was not contested on appeal. These patent claims cover Vyvanse’s active ingredient, the lisdexamfetamine dimesylate compound, and a method of using lisdexamfetamine dimesylate for the treatment of ADHD.
As to the API-manufacturer, the Court of Appeals of the Federal Circuit found that Johnson Matthey was not “liable for the API it sold the ANDA defendants up to this point” because it did not submit an ANDA.
What is Vyvanse?
Vyvanse is a prescription medicine used for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients 6 years and above. Vyvanse is not for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity.
IMPORTANT SAFETY INFORMATION
Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Vyvanse in a safe place to prevent misuse and abuse. Selling or giving away Vyvanse may harm others, and is against the law.
Vyvanse is a stimulant medicine. Tell the doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Who should not take Vyvanse?
Do not take Vyvanse if you or your child is:
Problems that can occur while taking Vyvanse. Tell the doctor:
What are possible side effects of Vyvanse?
The most common side effects of Vyvanse reported in ADHD studies include:
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For additional safety information, click here for Prescribing Information and Medication Guide and discuss with your doctor.
Vyvanse® (lisdexamfetamine dimesylate) is a registered trademark of Shire LLC. Vyvanse is available in 10, 20, 30, 40, 50, 60 and 70 mg capsules.
Shire enables people with life-altering conditions to lead better lives.
Our strategy is to focus on developing and marketing innovative specialty medicines to meet significant unmet patient needs.
We focus on providing treatments in Rare Diseases, Neuroscience, Gastrointestinal and Internal Medicine and are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas, such as Ophthalmics.
Investor Relations | ||
Matthew Osborne | Mattosborne@shire.com | +1 781 482 9502 |
arah Elton-Farr | seltonfarr@shire.com | +44 1256 894157 |
Media | ||
Michele Galen | mgalen@shire.com | +1 781 482 1867 |
Gwen Fisher | gfisher@shire.com | +1 781 482 9649 |
THE “SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included in this announcement that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, that: