Pharmaceutical

Shire plc (NASDAQ: SHPG) announces that its subsidiary, Shire Development LLC, welcomes yesterday’s favorable ruling against Abhai LLC in connection with their Abbreviated New Drug Application (ANDA) for a generic version of Shire’s ADDERALL XR.  ADDERALL XR is indicated for the treatment of attention deficit hyperactivity disorder in children and adults. As quoted in the …

Shire plc (NASDAQ: SHPG) announces that its subsidiary, Shire Development LLC, welcomes yesterday’s favorable ruling against Abhai LLC in connection with their Abbreviated New Drug Application (ANDA) for a generic version of Shire’s ADDERALL XR.  ADDERALL XR is indicated for the treatment of attention deficit hyperactivity disorder in children and adults.

As quoted in the press release:

Following a bench trial in the U.S. District Court of the District of Massachusetts, the judge issued a ruling holding that the proposed ANDA formulation infringes the claims of patents RE42,096 (a reissue of US 6,322,819) and RE41,148 (a reissue of US 6,605,300).  Accordingly, Abhai is prohibited from marketing its ANDA product until the expiration of the patents.

In addition, the court sanctioned Abhai for its litigation misconduct and directed that a certified copy of the court’s opinion be sent to FDA’s attention in light of what the court described as Abhai’s “pervasive corporate unwillingness to play by the rules.”  The amount of monetary sanctions to be paid to Shire will be determined at a later date.

Click here to read the full press release.

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