Recordati receives patent challenge notice for its drug Isturisa
Recordati said it received a Paragraph IV notice from a generic filer seeking FDA approval, with a copy not expected on the market before 2033.
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what happened
Italian drugmaker Recordati Industria Chimica e Farmaceutica said it received a Paragraph IV notice. The filer of an abbreviated new drug application has asked the US FDA to approve a generic copy of Isturisa. According to the company, generic entry is not expected before 2033, as the drug is shielded by five Orange Book patents expiring in 2031, 2033 and 2035.
why it matters
For investors this is a company-level development: long patent protection keeps Recordati's exclusive rights to Isturisa into the early 2030s. The news is unlikely to move broader markets.
tags
instruments
sources
- Recordati Says Generic Abbreviated New Drug Filer Asks US FDA Approval To Market Generic Version Of Own Drug Isturisa — Reuters, 20 October 2026 at 17:04 UTC
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