Zydus Sets Sight On First US Generic Of UCB’s Briviact
FDA Approves Brivaracetam ANDA With Shared 180-Day Exclusivity
Executive Summary
Zydus Cadila has scooped another material ANDA approval from the FDA, with the green light for its generic version of UCB’s Briviact to treat partial-onset seizures.
You may also be interested in...
ANDA Sponsors Swarm On Vimpat Blockbuster As Protection Expires
UCB’s Vimpat blockbuster has finally fallen to generic competition in the US, after its intellectual property was skewered by ANDA sponsors as part of a failed challenge before the US Supreme Court in 2018 and 2019.
UCB Jumps Early Onto M&A Merry-Go-Round With Zogenix Buy
Zogenix's Fintepla for Dravet syndrome got off to a slow start commercially and investors are hoping that the sales will improve considerably with UCB flexing its marketing muscles in the epilepsy space and growing the product as additional indications are secured.
AAM Weighs In On Supreme Court Challenge To UCB’s Lacosamide
Throwing its weight behind a US Supreme Court petition from Alembic, Mylan and Sun Pharma, local industry association the AAM has insisted that the top US court should correct the ‘lead compound test’ imposed by the Court of Appeals for the Federal Circuit and replace it with the statutory obviousness test.