What changed 10-K

Item 3. Legal Proceedings

2024-07-01 compared with 2023-06-29 · 7 added, 0 removed, 10 unchanged (41% of the section changed)

LEGAL PROCEEDINGS

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.

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 approval by the FDA and the outcome

of various litigations involving Purdue or the expiry of the patents listed on the Orange Book.

the ordinary course of business, we may be subject to litigation from time to time.

8 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.