In an attempt to block generic version of Ramelteon (Rozerem) 8 mg Tablets, innovator Takeda has filed an infringement action against generic player Teva pharma in U.S. District Court for the District of Delaware.
Innovator has listed following patent in the Orange Book for this product:
US6034239 (Expiry: Mar 6, 2017): The patent covers Ramelteon as product
The generic player Teva has challenged the said patent on various patent invalidation grounds.
Earlier, innovator got approval to market Ramelteon (Rozerem) 8 mg Tablets on Jul 22, 2005.
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