Parsippany, N.J. (Legal Newsline) — Actavis plc announced Wednesday it has settled with Noven Pharmaceuticals Inc. in a case over Actavis’ generic version of the medication Daytrana.
Actavis said in a statement that the agreement will settle all outstanding patent litigation related to the drug, a stimulant often used to treat Attention Deficit Hyperactivity Disorder, or ADHD, and sometimes narcolepsy.
Under the terms of the agreement, Noven will grant Actavis a non-exclusive, royalty-bearing license to market its generic version of Daytrana beginning Sept. 1, 2015, or earlier under certain circumstances.
Other details of the settlement were not disclosed.
The launch of Actavis’ generic is contingent upon the pharmaceutical company receiving final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application, or ANDA.
Actavis, which is headquartered in Dublin, Ireland, said it believes — based on available information — it may be a “first applicant” to file an ANDA for the Daytrana generic and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
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Original Story: Actavis, Noven reach settlement in Daytrana patent case