Axsome settles patent lawsuit with Hetero over SUNOSI

NEW YORK - Axsome Therapeutics, Inc. (NASDAQ: AXSM), a $5.2 billion market cap company specializing in central nervous system (CNS) disorder treatments, has reached a settlement with Hetero Labs Ltd. regarding a patent dispute over the drug SUNOSI (solriamfetol). According to InvestingPro data, the company maintains impressive gross profit margins of over 91% and has achieved revenue growth of 72% in the last twelve months. The agreement, announced today, concludes litigation in the United States District Court for the District of New Jersey.

The litigation followed Hetero’s submission of an Abbreviated New Drug Application for a generic version of SUNOSI. Per the settlement, Axsome will allow Hetero to market its generic version starting on or after September 1, 2040, with pediatric exclusivity, or March 1, 2040, without it, contingent on U.S. Food and Drug Administration approval.

The terms also encompass customary conditions and exceptions for such agreements. The settlement will be reviewed by the U.S. Federal Trade Commission and the U.S. Department of Justice, as mandated by law. Axsome’s similar patent litigation against other entities concerning SUNOSI is still pending.

Axsome Therapeutics’ portfolio includes FDA-approved treatments for major depressive disorder, narcolepsy, obstructive sleep apnea, and migraine. It also has several late-stage development programs for neurological and psychiatric conditions, potentially affecting over 150 million people in the U.S. With analysts setting price targets ranging from $146 to $210, InvestingPro subscribers can access detailed analysis and 6 additional ProTips about Axsome’s growth potential and financial health.

The company’s mission is to address gaps in CNS treatment and advance patient outcomes through novel mechanisms of action. Today’s settlement is part of Axsome’s ongoing efforts to protect its intellectual property and product portfolio, which includes SUNOSI, AUVELITY, and SYMBRAVO. For comprehensive insights into Axsome’s financial health, performance metrics, and detailed valuation analysis, investors can access the full Pro Research Report available exclusively on InvestingPro.

This news is based on a press release statement from Axsome Therapeutics, Inc.

In other recent news, Axsome Therapeutics reported its first-quarter 2025 earnings, revealing a net loss of $1.22 per share, which was better than the forecasted loss of $1.30. The company’s revenue for the quarter was $121.46 million, slightly below the expected $121.58 million. Axsome’s total product revenues increased by 62% year-over-year, driven by strong sales of its products, Auvelity and Sunosi. Additionally, Axsome secured a $570 million credit facility from Blackstone, aimed at enhancing its financial position and accelerating its path to profitability.

Meanwhile, analysts have provided mixed updates on Axsome’s stock. H.C. Wainwright lowered its price target to $180 from $200, maintaining a Buy rating, while BofA Securities slightly raised its target from $174 to $176, also maintaining a Buy rating. The adjustments reflect varied perspectives on Axsome’s financial outlook and product pipeline. The company is preparing to launch SYMBRAVO for acute migraine treatment, which has shown positive results in trials.

Axsome’s financial stability is underscored by its cash reserves of $300.9 million, expected to support operations until the company reaches cash flow positivity early next year. The firm continues to focus on expanding its sales force and launching new marketing campaigns to support future growth. These developments indicate Axsome’s strategic efforts to strengthen its market position and enhance shareholder value.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.