Mylan has entered into a settlement and license agreement with Abbott Laboratories relating to a generic version of Abbott's anti-seizure drug Depakote ER.
According to a filing with the Securities and Exchange Commission, Mylan Pharmaceuticals has been granted a 180-day exclusivity period to sell 500 mg Divalproex extended-release tablets upon their launch, which will occur no later than Jan. 1, 2009. The agreement also provides a license for the 250 mg tablets to be launched no later than Jan. 1, 2009. Subsequently, all litigation between Mylan and Abbott relating to Divalproex ER will be dismissed, the filing said. Abbott first filed a patent infringement suit against Mylan relating to its Depakote Extended-Release drug in November 2005. The formulation patents for the drug expire in 2018, the company said. Depakote, including the extended-release version, had U.S. sales of $1.48 billion in 2007. divalproex sodium consists of a compound of sodium valproate and valproic acid in a 1:1 molar relationship in an enteric coated form. It is used in the UK and U.S. for the treatment of the manic episodes of bipolar disorder, and increasingly taken long-term for prevention of both manic and depressive phases of bipolar disorder, especially the rapid-cycling variant. It is also used in the US for the treatment of epilepsy, chronic pain associated with neuropathy, and migraine headaches. Its chemical name is sodium hydrogen bis(2-propylpentanoate).
According to a filing with the Securities and Exchange Commission, Mylan Pharmaceuticals has been granted a 180-day exclusivity period to sell 500 mg Divalproex extended-release tablets upon their launch, which will occur no later than Jan. 1, 2009. The agreement also provides a license for the 250 mg tablets to be launched no later than Jan. 1, 2009. Subsequently, all litigation between Mylan and Abbott relating to Divalproex ER will be dismissed, the filing said. Abbott first filed a patent infringement suit against Mylan relating to its Depakote Extended-Release drug in November 2005. The formulation patents for the drug expire in 2018, the company said. Depakote, including the extended-release version, had U.S. sales of $1.48 billion in 2007. divalproex sodium consists of a compound of sodium valproate and valproic acid in a 1:1 molar relationship in an enteric coated form. It is used in the UK and U.S. for the treatment of the manic episodes of bipolar disorder, and increasingly taken long-term for prevention of both manic and depressive phases of bipolar disorder, especially the rapid-cycling variant. It is also used in the US for the treatment of epilepsy, chronic pain associated with neuropathy, and migraine headaches. Its chemical name is sodium hydrogen bis(2-propylpentanoate).
