Jazz Pharmaceuticals Plc - Form 8-K Summary
Business Context and Reporting Period
This Current Report on Form 8-K was filed by Jazz Pharmaceuticals Plc on June 4, 2013. The report details specific intellectual property events regarding the company's product Xyrem (sodium oxybate) oral solution.
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 patent issuance and regulatory listings rather than financial performance.
Material Changes and Events
- New Patent Issued: The USPTO issued U.S. Patent No. 8,457,988, titled "Sensitive Drug Distribution System and Method," related to Xyrem distribution.
- Orange Book Listing: The new patent will be submitted for listing in the FDA's Orange Book. It is the company's tenth patent referencing Xyrem and expires on June 16, 2024.
- Existing Portfolio: Other listed patents for Xyrem expire at various times between 2019 and 2024.
- Projected Patent: The USPTO notified the company that U.S. Patent No. 8,461,203, related to the process of making Xyrem, is projected to issue on June 11, 2013.
- Exclusion from Listing: The company does not expect to submit the projected patent (No. 8,461,203) to the Orange Book. Its expiry date is December 22, 2019.
Outlook, Risks, and Forward-Looking Statements
The report contains forward-looking statements regarding the expected issuance of the additional patent. Management notes that actual results and timing could differ materially due to USPTO actions and risks associated with intellectual property protection. The company disclaims any obligation to update these statements based on new information or future events.
Investor Verification Checklist
- Confirm the official listing of U.S. Patent No. 8,457,988 in the FDA Orange Book.
- Verify the actual issuance date of U.S. Patent No. 8,461,203 (projected for June 11, 2013).
- Review the "Risk Factors" section in the company's Form 10-Q for the quarter ended March 31, 2013, for details on intellectual property risks.
- Monitor the expiration timeline of the company's Xyrem patent portfolio (2019–2024).