Jazz Pharmaceuticals JAZZ Xyrem — Number of patents, paragraph IV certification notice filed
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Where this comes from
Reported directly by Jazz Pharmaceuticals in its filing.
Tagged under the XBRL concept jazz:NumberOfPatentsParagraphIVCertificationNoticeFiled.
The source filing: Jazz Pharmaceuticals’s 10-Q, filed May 5, 2026.
- Filed
- May 5, 2026, 4:09 PM EDT
- Fiscal quarter
- Q1 FY2026
- Calendar quarter
- Q1 2026
- Accession
- 0001232524-26-000025
In January 2026, we received notices from Tris Pharma that it had filed with FDA a Section 505(b)(2) NDA with Xyrem and Xywav as reference listed drugs. The first notice included a paragraph IV certification with respect to seven patents listed in FDA’s Orange Book for Xyrem, and the second notice included a paragraph IV certification with respect to fifteen patents listed in FDA’s Orange Book for Xywav on the date of our receipt of the notice. Seven of the listed patents relate generally to methods of treatment when Xywav or Xyrem is administered concomitantly with certain other medications, and the remaining eight relate generally to the composition and method of use of Xywav.
Item 1.Financial Statements
FAQ
- What is Jazz Pharmaceuticals's xyrem — number of patents, paragraph IV certification notice filed?
- Jazz Pharmaceuticals (JAZZ) reported xyrem — number of patents, paragraph IV certification notice filed of 7 in Q1 2026.
- What does xyrem — number of patents, paragraph IV certification notice filed mean?
- This metric tracks the count of Paragraph IV certification notices received from generic drug manufacturers challenging the validity or enforceability of patents protecting a specific pharmaceutical product. It serves as a critical indicator of impending generic competition and potential loss of market exclusivity. Monitoring this helps investors gauge the legal pressure on a product's intellectual property moat.
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