UCB announced that the USFDA has granted pediatric exclusivity for Keppra(R) (Levetiracetam). The decision was based on pediatric data submitted to the FDA following a written request in 2001. The Keppra(R) US '639 patent was set to expire in July 2008, however, this grant extends the period of exclusivity on Keppra(R) across all licensed indications by six months to January 2009. Only one patent is listed in Orange Book for this product
In October 2007, UCB announced that it had reached an agreement to settle pending patent infringement lawsuits in the US. Under the terms of the settlement agreement with Mylan, and subject to its receiving FDA approval, Mylan will be allowed to sell its generic levetiracetam tablets effective November 1, 2008, in advance of the expiry of UCB's market exclusivity on January 14, 2009.
Levetiracetam is an anticonvulsant medication used to treat epilepsy. It is S- enantiomer of Etiracetam, structurally similar to the prototypical nootropic drug Piracetam. Along with other anticonvulsants like Gabapentin, it is also sometimes used to treat neuropathic pain.
In October 2007, UCB announced that it had reached an agreement to settle pending patent infringement lawsuits in the US. Under the terms of the settlement agreement with Mylan, and subject to its receiving FDA approval, Mylan will be allowed to sell its generic levetiracetam tablets effective November 1, 2008, in advance of the expiry of UCB's market exclusivity on January 14, 2009.
Levetiracetam is an anticonvulsant medication used to treat epilepsy. It is S- enantiomer of Etiracetam, structurally similar to the prototypical nootropic drug Piracetam. Along with other anticonvulsants like Gabapentin, it is also sometimes used to treat neuropathic pain.
