Lupin has received tentative approval for extended-release (ER) Oxcarbazepine tablets.



Lupin announced that it has received tentative approval from the USFDA for its abbreviated new drug application (ANDA) for Oxcarbazepine extended-release (ER) tablets. Oxcarbazepine ER Tablets in 150 mg, 300 mg, and 600 mg dosages are bioequivalent to Oxtellar XR® ER Tablets, also available in 150 mg, 300 mg, and 600 mg, from Supernus Pharmaceuticals, Inc., and are indicated for the treatment of partial-onset seizures. This product will be manufactured at Lupin’s Nagpur facility in India. Oxcarbazepine ER tablets (RLD Oxtellar XR) had estimated annual sales of $206 million in the U.S. (IQVIA MAT April 2025).

The Lupin Press Release can be found here.


Apotex Corp. is the first generic manufacturer to launch oxcarbazepine ER tablets in the United States; Apotex made this launch in September 2024. There are four other tentative approvals for oxcarbazepine ER tablets, and several patents listed in the Orange Book. 


Supernus Pharmaceuticals and Apotex Corp. settled a patent infringement case concerning Oxtellar XR. This agreement allows Apotex to launch a generic version of Oxtellar XR on September 1, 2024, following FDA approval.



I could not find information about the probable launch dates of other companies that sought tentative approvals from the FDA. Additionally, I could not locate information in the public domain regarding whether other companies have also agreed on a launch date with Supernus Pharmaceuticals. Perhaps these companies, including Lupin, will wait until 2027 when the composition patent related to a pharmaceutical formulation for once-a-day administration of oxcarbazepine expires. This needs to be evaluated in detail. 


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