INCYTE CORP (INCY) Risk Factors

Recent key developments

Concrete developments — dated events, named agreements and instruments, legal proceedings — that INCYTE CORP surfaced in its latest filing.

• JAKAFI patent exclusivity expires in 2028, including composition of matter and use patents (June 2028) and ruxolitinib phosphate patents (December 2028).2028
• Received paragraph IV certification notices and have pending patent infringement actions against multiple generic manufacturers for JAKAFI, with confidential settlements reached with some.
• Received paragraph IV certification notice letters from Padagis, Taro, Zydus, and Encube for generic OPZELURA, with pending patent infringement actions.
• FDA issued a complete response letter for the NDA of OLUMIANT for moderate-to-severe rheumatoid arthritis.April 2017
• FDA approved only the 2mg dose of OLUMIANT for adults with moderately-to-severely active rheumatoid arthritis with inadequate response to TNF inhibitors, and required a warning label.June 2018
• Withdrew the NDA for parsaclisib for relapsed or refractory follicular lymphoma, marginal zone lymphoma, and mantle cell lymphoma.January 2022
• Received a complete response letter for ruxolitinib extended release tablets, identifying additional requirements for approval.March 2023
• Phase 3 trial of itacitinib for acute graft-versus-host-disease was stopped.January 2020
• FDA issued a complete response letter for the BLA of retifanlimab for squamous cell carcinoma of the anal canal.July 2021
• EMA review of ICLUSIG due to vascular events completed with additional warnings.January 2015
• FDA updated labeling for JAKAFI and other JAK inhibitors to include boxed warnings for cardiovascular events, thrombosis, and secondary malignancies.September 2021
• The American Rescue Plan Act of 2021 eliminated the statutory cap on Medicaid rebates starting January 2024.January 2024
• The ORPHAN Cures Act in 2025 extended the timeline for ruxolitinib phosphate to become eligible for Medicare drug price negotiation.2025
• Executive order issued on May 12, 2025, directed HHS to establish MFN price targets and pursue rulemaking for U.S. prices no higher than in comparable developed nations.May 12, 2025
• Entered into a purchase agreement with MorphoSys AG to acquire rights to tafasitamab (MONJUVI/MINJUVI), resulting in exclusive global development and commercialization rights.February 2024
• Entered into an agreement to acquire Vega Therapeutics and its novel antibody therapies for rare blood disorders.June 2026
• Acquired Escient Pharmaceuticals, Inc., but later stopped development of the two lead compounds.2024
• Opted out of continued development with Merus of MCLA-145.January 2022
• Terminated collaborations with Calithera Biosciences, Inc. and Syros Pharmaceuticals, Inc.2022 and 2023
• The One Big Beautiful Bill Act was enacted in July 2025, affecting R&D expensing and tax rates.July 2025
• The Inflation Reduction Act of 2022 introduced a 15% alternative minimum tax on large corporations.2022
• OECD BEPS 2.0 Pillar Two global minimum tax rules became effective in tax year 2024.2024