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Arcutis seeks a judgment that Padagis has infringed or will infringe one or more claims of each of the Asserted Patents and based on that judgment, a permanent injunction prohibiting the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of Padagis’s proposed generic product before expiration of each of the Asserted Patents found to infringe.
−Removed: On July 19, 2024, Arcutis filed its first amended complaint that added the last five of the above listed patents to its infringement allegations.
−Removed: These patents were issued by the U.S.
−Removed: Patent and Trademark Office and listed in FDA’s Orange Book for Arcutis’s ZORYVE® 0.3% cream after the filing of the original complaint.
−Removed: On August 2, 2024, Padagis responded to the first amended complaint, denying infringement and asserting counterclaims seeking a declaratory judgement that the asserted patents are not infringed, invalid, and/or unenforceable.
+Added: In March 2025, Arcutis agreed to file a joint stipulation to stay the ongoing patent litigation with Padagis at the request of Padagi s.
On April 3, 2025, the court stayed the case and cancelled all case deadlines, including the trial.
7 unchanged sentences
On February 19, 2025, Arcutis received Teva’s reply to Arcutis’s January 23, 2025 submission for EP 3684334 to which Arcutis filed an additional reply on April 16, 2025.
−Removed: Hearings before the EPO’s Opposition Division are not yet scheduled and the proceedings are ongoing.
+Added: Oral proceedings concerning the oppositions to European Patent Nos.
+Added: EP 3634380 B1 and EP 3684334 B1 have been scheduled for January 8, 2026, and December 4, 2025, respectively.
We may from time to time be involved in various legal proceedings of a character normally incident to the ordinary course of our business.
We are not currently a party to any material litigation or other material legal proceedings.
−Removed: For a discussion of our potential risks and uncertainties, see the information in Part I, "Part I, Item 1A.
−Removed: Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024.
−Removed: There have been no material changes to the risk factors disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024.
−Removed: UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
−Removed: Issuer Purchases of Equity Securities
−Removed: DEFAULTS UPON SENIOR SECURITIES
−Removed: MINE SAFETY DISCLOSURES
−Removed: Not applicable.
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.