ELITE PHARMACEUTICALS INC /NV/ 10-Q

ITEM 1. LEGAL PROCEEDINGS Pending Litigation Elite filed a paragraph IV certification with its ANDA to generic Oxycontin 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 Act. This was followed by a patent infringement suit filed in the District Court of New Jersey by Purdue Pharma. Elite obtained agreement with Purdue to stay the litigation for six months. Elite’s launch of a generic Oxycontin will depend upon approval by the FDA and on the outcome of various litigations involving Purdue or the expiry of the patents listed on the Orange Book. Elite and Purdue agreed to a stay of the litigation for six months which the court ordered on January 17, 2024. The stay was extended for an additional six months by an order from the court on July 15, 2024. During the additional six months a decision was rendered in the Purdue Pharma L.P. v. Accord Healthcare Inc. , Civil Action No. 22-913-WCB (“ Accord II ”) on September 9, 2024 which according to the order required Elite and Purdue to submit a joint report to the court. On September 26, 2024, the court ordered that proceedings in the Elite case be stayed pending the decision of Case No. 23-1953 in the Court of Appeals for the Federal Circuit (“Accord I”). According to the order Purdue and Elite must submit a joint report within 15 days of the decision. ITEM 1A. RISK FACTORS There 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. ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS None. ITEM 3. DEFAULTS UPON SENIOR SECURITIES None. ITEM 4. MINE SAFETY DISCLOSURES Not applicable.