First-Time Generic Trileptal Approvals

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 Joined: 2005-01-07

In October 2007 the US Food and Drug Administration approved the first generic versions of Trileptal (oxcarbazepine).

Oxcarbazepine, an anticonvulsant, helps control partial seizures in people with epilepsy. Some off-label uses of oxcarbazepine are treatment of nerve pain from trigeminal neuralgia and treatment of bipolar disorder.

According to the press release issued by Roxane Laboratories, annual sales of oxcarbazepine total approximately $660 million.

Three manufacturers will market oxcarbazepine in three strengths - 150 milligrams, 300 milligrams and 600 milligrams. The approved manufacturers are Sun Pharmaceutical Industries (Caraco), Glenmark Pharmaceuticals and Roxane Laboratories. The Sun and Glenmark products are made in India.

Pill imprints for all strengths of oxcarbazepine are summarized below.

Oxcarbazepine Approvals

Pill Identification by Manufacturer
Manufacturer Milligrams Tablet Description Pill Imprint
Caraco 150 Oblong yellow 183
300 Oblong yellow 184
600 Oblong yellow 185
Glenmark 150 Oval yellow G 137
300 Oval yellow G4
600 Oval yellow G 139
Roxane 150 Round peach 54 331
300 Round peach 54 515
600 Oval peach 54 171

Sources: US Food and Drug Administration and Manufacturers' Websites


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Submitted by TP Admin on November 11, 2007 - 10:49am. login or register to post comments