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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
+Added: 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.
On November 14, 2023, a patent infringement suit was filed in the District Court of New Jersey by Purdue Pharma.
−Removed: submitted several stipulations and proposed orders for staying the case until March 19, 2025 where the parties submitted a
−Removed: stipulation and order lifting the existing stipulated stay.
+Added: The parties submitted
+Added: several stipulations and proposed orders for staying the case until March 19, 2025 where the parties submitted a stipulation and order
+Added: lifting the existing stipulated stay.
On April 18, 2025 Purdue filed an amended complaint.
−Removed: On June 17, 2025
−Removed: Elite filed a Motion to Dismiss Purdue’s First Amended Complaint.
+Added: On June 17, 2025 Elite filed a Motion to Dismiss
+Added: Purdue’s First Amended Complaint.
On July 3, 2025 Purdue filed a Second Amended Complaint.
−Removed: Elite filed a Motion to Dismiss Purdue’s Second Amended Complaint on August 7, 2025.
−Removed: On September 2, 2025 Purdue filed an Opposition to Defendants’ Motion to Dismiss Plantiffs’ Second Amended
−Removed: Complaint and Cross-Motion to Extend the 30-Month Stay.
−Removed: On September 29, 2025 Elite filed a Reply memorandum in Support of their Motion
−Removed: to Dismiss and in Opposition to Plantiffs’ Cross Motion to Extend the 30-Month Stay.
+Added: Elite filed a Motion to Dismiss Purdue’s
+Added: Second Amended Complaint on August 7, 2025.
+Added: On September 2, 2025 Purdue filed an Opposition to Defendants’ Motion to Dismiss Plantiffs
+Added: Second Amended Complaint and Cross-Motion to Extend the 30-Month Stay.
+Added: On September 29, 2025 Elite filed a Reply memorandum in Support
+Added: of their Motion to Dismiss and in Opposition to Plantiffs Cross Motion to Extend the 30-Month Stay.
launch of a generic OxyContin® will depend on approval by the FDA and the outcome of various litigation involving Purdue or the expiry
13 unchanged sentences
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.