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 ANDA
−Removed: by the FDA on September 19, 2023, Elite sent the patentee and NDA holder a Notice Letter as required under the Hatch-Waxman Act.
−Removed: 14, 2023, a patent infringement suit was filed in the District Court of New Jersey by Purdue Pharma.
−Removed: Elite obtained agreement with Purdue
−Removed: to stay the litigation for six months.
−Removed: Elite’s launch of a generic Oxycontin will depend on approval by the FDA and the outcome
−Removed: of various litigation involving Purdue or the expiry of the patents listed on the Orange Book.
+Added: Elite filed a paragraph IV certification with its ANDA to generic Oxycontin
+Added: and after Elite got acceptance of the ANDA by the FDA, Elite sent the patentee and NDA holder a Notice Letter as required under the Hatch-Waxman
+Added: This was followed by a patent infringement suit filed in the District Court of New Jersey by Purdue Pharma.
+Added: Elite obtained agreement
+Added: with Purdue to stay the litigation for six months.
+Added: Elite’s launch of a generic Oxycontin will depend upon approval by the FDA and
+Added: on the outcome of various litigations involving Purdue or the expiry of the patents listed on the Orange Book.
+Added: Elite and Purdue agreed
+Added: to a stay of the litigation for six months which the court ordered on January 17, 2024.
+Added: The stay was extended for an additional six months
+Added: by an order from the court on July 15, 2024.
+Added: During the additional six months a decision was rendered in the Purdue Pharma L.P.
+Added: Accord Healthcare Inc.
+Added: , Civil Action No.
+Added: 22-913-WCB (“ Accord II ”) on September 9, 2024 which according to the order
+Added: required Elite and Purdue to submit a joint report to the court.
+Added: On September 26, 2024, the court ordered that proceedings in the Elite
+Added: case be stayed pending the decision of Case No.
+Added: 23-1953 in the Court of Appeals for the Federal Circuit (“Accord I”).
+Added: to the order Purdue and Elite must submit a joint report within 15 days of the decision.
have been no material changes in the risk factors described in our Annual Report on Form 10-K for the fiscal year ended March 31, 2024.
3 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.