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2 August 2017Americas

Endo sues Lupin over nasal spray

Drugs maker Endo Pharmaceuticals has accused Lupin Atlantis, a subsidiary of Lupin, of patent infringement.

The claim, filed on Friday, July 28 at the US District Court for the Eastern District of Texas, Marshall Division, centred on an Abbreviated New Drug Application (ANDA) submitted by Lupin.

Endo is the holder of approved New Drug Application number 021642 for Nascobal (cyanocobalamin), a nasal spray.

Cyanocobalamin is a synthetic form of vitamin B12, and Nascobal is a prescription medicine used to treat vitamin deficiency.

Lupin is accused of infringing US patent numbers 7,229,636; 7,404,489; 7,879,349; 8,003,353; 8,940,714; and 9,415,007, which are all called “Cyanocobalamin low viscosity aqueous formulations for intranasal delivery”.

According to the claim, Lupin notified Endo in June this year that it had submitted an ANDA to the Food and Drug Administration.

The letter allegedly said that Endo’s patents are invalid, unenforceable, and/or will not be infringed by Lupin’s manufacture of the nasal spray.

Endo is seeking a permanent injunction until the expiration of the patents, an order that the date of the ANDA’s approval will not be effective until Endo’s patents have expired, attorneys’ fees, costs and other relief the court deems just and proper.

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