Item 1. Legal Proceedings
ITEM
1. LEGAL PROCEEDINGS
Pending
Litigation
On August 17, 2023, Elite filed a paragraph IV certification with its ANDA to generic Oxycontin and after Elite got
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
Hatch-Waxman Act. On November 14, 2023, a patent infringement suit was 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 on the approval
by the FDA and the outcome of various litigations involving Purdue or the expiry of the patents listed on the Orange Book.
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, 2023,
except as set forth in our Quarterly Report on Form 10-Q for the fiscal quarter ended December 31, 2023.
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.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.