LEGAL PROCEEDINGS
−Removed: August 17, 2023, Elite filed a Paragraph IV certification with its ANDA to generic OxyContin® and after Elite got acceptance of the
−Removed: ANDA by the FDA on September 19, 2023, Elite sent the patentee and NDA holder a Notice Letter as required under the Hatch-Waxman Act.
+Added: August 17, 2023, the Company filed a Paragraph IV certification with its ANDA to generic OxyContin® and after the Company received
+Added: acceptance of the ANDA by the FDA on September 19, 2023, Elite sent the patentee and NDA holder a Notice Letter as required under the
+Added: Hatch-Waxman Act.
On November 14, 2023, a patent infringement suit was filed in the District Court of New Jersey by Purdue Pharma.
−Removed: The parties submitted
−Removed: several stipulations and proposed orders for staying the case until March 19, 2025 where the parties submitted a stipulation and order
−Removed: lifting the existing stipulated stay.
−Removed: On April 18, 2025 Purdue filed an amended complaint.
−Removed: On June 17, 2025 Elite filed a Motion to Dismiss
−Removed: Purdue’s First Amended Complaint.
−Removed: On July 3, 2025 Purdue filed a Second Amended Complaint.
−Removed: Elite filed a Motion to Dismiss Purdue’s
−Removed: Second Amended Complaint on August 7, 2025.
−Removed: On September 2, 2025 Purdue filed an Opposition to Defendants’ Motion to Dismiss Plantiffs
−Removed: Second Amended Complaint and Cross-Motion to Extend the 30-Month Stay.
−Removed: On September 29, 2025 Elite filed a Reply memorandum in Support
−Removed: of their Motion to Dismiss and in Opposition to Plantiffs Cross Motion to Extend the 30-Month Stay.
+Added: parties agreed to a stipulated dismissal of the case and the judge signed the order dismissing the case on June 12, 2026.
launch of a generic OxyContin® will depend on approval by the FDA and the outcome of various litigation involving Purdue or the expiry
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.