Shire Pharmaceuticals of the UK says that it has received a Paragraph IV Notice letter from Teva Pharmaceuticals USA advising of the filing of an Abbreviated New Drug Application for its amphetamine combination product, a generic version of Shire's attention-deficit hyperactivity disorder drug Adderall XR.
The UK firm says that Adderall XR is the lead product in its portfolio of treatments for ADHD and is protected by two patents which expire in 2018: Shire's US patent numbers 6,322,819 and 6,605,300.
Shire has previously received Paragraph IV Notice letters from Barr Laboratories, IMPAX Laboratories and Colony Pharmaceuticals relating to their ANDAs for their respective generic versions of Adderall XR, and has filed law suits in response to these.
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