The approved product is a generic version of the reference listed drug (RLD) Lamictal ODT by GlaxoSmithKline and is indicated for the treatment of epilepsy and bipolar disorder
Brivaracetam Oral Solution (10 mg/mL) is a prescription antiepileptic drug (anticonvulsant) used for treatment of partial-onset seizures in patients 1 month of age and older
Brivaracetam is the bioequivalent to Briviact Oral Solution, 10 mg/mL, of UCB
Under the deal, Quiver will receive an undisclosed advance payment and research support
Topiramate Extended-Release Capsules are bioequivalent to the reference listed drug (RLD), Trokendi XR Extended-Release Capsules of Supernus Pharmaceuticals
The approved Lacosamide Oral Solution is bioequivalent and therapeutically equivalent to the reference drug and will be manufactured at Indoco’s facility in Verna Industrial Area, Goa
GRIN-NDD is one of the most complex neurodevelopmental disorders with limited treatment options today
Clinical evidence has consistently highlighted lacosamide’s efficacy and safety.
Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)
Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity
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