Datapoint: Appeals Court Invalidates Gilenya Patent

Reversing a lower court decision, a U.S. federal appeals court last week found a key patent for Novartis’ Gilenya invalid, opening the floor for HEC Pharm Co.’s generic challenger. The patent covers the drug’s dosing schedule — 0.5 mg per day — in relapsing multiple sclerosis patients. Novartis says it will contest the ruling. Gilenya was Novartis’ third best-selling drug in 2021, bringing in $2.79 billion in sales. For the treatment of multiple sclerosis, virtually all insured lives (99%) have covered or better access to Gilenya under the pharmacy benefit. 11% of insured lives have preferred access to Gilenya without utilization management restrictions.

SOURCE: MMIT Analytics, as of 6/22/22, and Evaluate Pharma.

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