- Swiss drug major Novartis AG NVS plans a petition the US Supreme Court to maintain the validity of the Gilenya (fingolimod) dosing regimen patent.
- The decision comes after the United States Court of Appeals for the Federal Circuit (CAFC) denied its request to rehear the decision regarding patient validity covering a Gilenya 0.5 mg dosing regimen.
- In August 2020, the US District Court for the District of Delaware entered an affirmative decision.
- An injunction has been issued against HEC Pharma pending the expiration of the ‘405 patent in December 2027, including pediatric exclusivity.
- After initially confirming the patent in January, the CAFC ruled in June that it was invalid, opening the door to low-cost competition for Novartis’ third-largest product.
- HEC Pharma was the only remaining Abbreviated New Drug Applicant, or ANDA, to challenge this patent.
- With the recent decision, HEC and other FDA-approved generic submissions will potentially be able to bring a generic version of 0.5 mg Gilenya to market shortly.
- Regarding the financial impact, Novartis said that with the launch of the generic in the US, sales would be negatively impacted by $0.3 billion in FY22. However, it still forecasts “mid-single-digit growth” in revenue and core operating income.
- Price promotion: NVS shares are up 1.45% to $80.73 during the premarket session last check Wednesday.
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