Shire plc the global specialty biopharmaceutical company, announces that its subsidiaries Shire LLC and Shire Development Inc. has received a new Paragraph IV Notice Letter from Watson Laboratories, Inc. in Fort Lauderdale, Florida advising of the filing of an Abbreviated New Drug Application (ANDA) for a generic version of all approved strengths of Shire’s Adderall XR (mixed salts of a single-entity amphetamine product) dextroamphetamine sulphate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, amphetamine sulphate capsules, CII.
The new ANDA that Watson filed is not covered under the existing settlement agreements entered into in November 2007 between Shire and Watson (the Settlement Agreements). The Settlement Agreements cover a different ANDA and do not provide any license for Watson to sell the products covered in Watson’s new ANDA.
Adderall XR is protected by the following FDA Orange Book listed patents: US Reissued Patent RE41,148, which is a reissue of US Patent No. 6,605,300, and US Patent No. 6,322,819, which has recently reissued as US Reissued Patent RE42,096. Patent protection will expire in April 2019.
Shire is currently reviewing the details of Watson’s Paragraph IV Notice Letter which was directed to each of the Orange Book listed patents. Under the Hatch-Waxman Act, Shire has 45 days from the receipt of the Notice Letter to determine if it will file a patent infringement suit. If Shire brings suit pursuant to the Hatch Waxman regulations, a stay of approval of up to 30-months will be imposed by the FDA on Watson’s ANDA.
Shire submitted a Citizen Petition (CP) to the FDA in October 2005 requesting that the FDA impose stricter bioequivalence standards before approving any ANDA for Adderall XR. The FDA responded that the CP raised “complex issues” and has not resolved the matter. The FDA has not approved any ANDA for Adderall XR.
Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician and focuses its business on Attention Deficit Hyperactivity Disorder (ADHD), Human Genetic Therapies (HGT) and Gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions.