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The US FDA has granted its final approval for Sun Pharmaceutical Industries'' abbreviated
new drug application (ANDA) to market its generic version of Novartis Trileptal,
oxcarbazepine tablets. These
generic oxcarbazepine tablets are AB-rated equivalent of Novartis Trileptal tablets
and include three strengths: 150 mg, 300 mg and 600 mg. These strengths of Trileptal
have annual sales of approximately $640 million in the US. Sun
Pharma, being one of the first-to-file an ANDA for generic Trileptal with a para
IV certification, shares a 180-day marketing exclusivity with a "No action
for patent infringement" has been brought against Sun Pharma. Oxcarbazepinc
is indicated for use as monotherapy or adjunctive therapy in the treatment of
partial seizures. Glenmark
Pharmaceuticals Ltd has also received final US Food and Drug Administration approval
for the marketing the first generic version of Trileptal (oxcarbazepine) also
in three strengths - 150 mg, 300 mg and 600 mg. (See:
Glenmark Pharmaceuticals to market epilepsy drug oxcarbazepine in the US)
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