Vanda Pharmaceuticals Inc. - 8-K Summary
Business Context and Reporting Period
This Form 8-K was filed on October 4, 2018, reporting an event that occurred on October 3, 2018. The filing concerns Vanda Pharmaceuticals Inc., a Delaware corporation, and specifically addresses an update to the U.S. Food and Drug Administration's Orange Book regarding the company's patent portfolio for its product HETLIOZ.
Key Financial Metrics
The filing text does not provide a clear value for revenue, profit, cash flow, margins, debt, or liquidity. This report focuses exclusively on a regulatory and intellectual property event rather than financial performance.
Material Changes
The primary material change reported is the extension of the expiration date for Vanda's new chemical entity patent (number 5,856,529) for HETLIOZ. The FDA updated the Orange Book to reflect the receipt of the full five-year extension under the Hatch-Waxman Act. Previously, this patent was set to expire in December 2018 following an interim one-year extension granted in 2017. With this update, the patent expiration date is now December 2022, absent other applicable extensions.
Outlook, Risks, and Management Commentary
Management highlights that Vanda currently holds a total of 8 patents covering HETLIOZ listed in the Orange Book. The latest of these patents has an expiration date of February 2035. The filing does not contain specific forward-looking financial guidance, risk factors, or contingencies beyond the patent status update.
Key Facts for Investor Verification
- Patent 5,856,529 for HETLIOZ now expires in December 2022 due to a full five-year Hatch-Waxman extension.
- Vanda holds 8 total patents for HETLIOZ in the Orange Book.
- The latest patent expiration date in the portfolio is February 2035.
- No financial data or operational metrics are disclosed in this specific filing.