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Remeron Soltab generic approved

Executive Summary

Barr receives approval of generic for Organon's Remeron Soltab (mirtazapine orally disintegrating tablets) on Dec. 17. Barr has 180-day exclusivity and plans to launch the product immediately. Barr was originally sued regarding two patents, but Organon delisted them in April following a ruling regarding Pfizer's Neurontin (gabapentin) which found that patents unrelated to approved uses could not be listed (1"The Pink Sheet" Feb. 3, 2003, p. 20). Barr's exclusivity is based on a patent listed by dosage-form developer Cima, which did not sue. Barr noted that it could be sued over two Organon patents not listed in the "Orange Book"...
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