LEGAL PROCEEDINGS
−Removed: On August 17, 2023, Elite filed a paragraph IV certification with its ANDA to generic Oxycontin and after Elite got
−Removed: 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
−Removed: Hatch-Waxman Act.
−Removed: On November 14, 2023, a patent infringement suit was filed in the District Court of New Jersey by Purdue Pharma.
−Removed: obtained agreement with Purdue to stay the litigation for six months.
−Removed: Elite’s launch of a generic Oxycontin will depend on the approval
−Removed: by the FDA and the outcome of various litigations involving Purdue or the expiry of the patents listed on the Orange Book.
+Added: August 17, 2023, Elite filed a paragraph IV certification with its ANDA to generic Oxycontin and after Elite got acceptance of the ANDA
+Added: 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: 14, 2023, a patent infringement suit was filed in the District Court of New Jersey by Purdue Pharma.
+Added: Elite obtained agreement with Purdue
+Added: to stay the litigation for six months.
+Added: Elite’s launch of a generic Oxycontin will depend on approval by the FDA and the outcome
+Added: of various litigation involving Purdue or the expiry of the patents listed on the Orange Book.
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.
−Removed: except as set forth in our Quarterly Report on Form 10-Q for the fiscal quarter ended December 31, 2023.
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
2 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.