Axsome Therapeutics Settles Sunosi® (solriamfetol) Patent Litigation with Unichem Laboratories
Axsome Therapeutics (NASDAQ: AXSM) announced a settlement with Unichem Laboratories regarding patent litigation for Sunosi® (solriamfetol). The litigation arose after Unichem filed for FDA approval to market a generic version of Sunosi in the U.S. per an Abbreviated New Drug Application. The settlement allows Unichem to sell its generic version starting June 30, 2042, with possible earlier entry under specific conditions. Additionally, the date could be extended for pediatric exclusivity. The agreement will be reviewed by the U.S. Federal Trade Commission and the Department of Justice. Similar litigation with other parties continues in the District of New Jersey.
- Settlement reached, reducing litigation uncertainty.
- Generic entry delayed to June 2042, maintaining market exclusivity for Sunosi.
- Potential extension for pediatric exclusivity.
- Future market competition from generic versions starting 2042.
- Pending litigation with other parties remains unresolved, posing ongoing legal risks.
The settlement between Axsome Therapeutics and Unichem Laboratories is significant for Axsome's financial outlook. Sunosi® (solriamfetol) is a key asset for Axsome, contributing notably to its revenue stream. Extending the market exclusivity of Sunosi until June 30, 2042 delays the entry of generic competitors, thereby protecting Axsome's revenue from this product for a longer period. This can potentially bolster the company's financial stability and growth, enhancing long-term shareholder value. Axsome's stock may see a positive reaction in the short term as investors respond to the extended revenue protection. However, investors should remain cautious of the ongoing litigation with other parties, which could introduce future uncertainties. The settlement agreement pending review by the FTC and DOJ adds another layer of regulatory risk.
In summary, the financial implications of this settlement are favorable for Axsome. The delay in generic competition secures a more predictable revenue flow from Sunosi.
From a legal standpoint, the settlement agreement between Axsome Therapeutics and Unichem Laboratories is a strategic move to mitigate the risks associated with prolonged litigation. By allowing Unichem to market a generic version of Sunosi starting June 30, 2042, Axsome effectively secures a substantial period of exclusivity. The possibility of an extension for pediatric exclusivity further reinforces this shield. This settlement avoids the uncertainties and costs of litigation, which can be unpredictable. However, the agreement is subject to review by the Federal Trade Commission and the Department of Justice, adding a layer of scrutiny that could affect its final execution.
The ongoing litigation with other parties in the same district court signifies that Axsome is actively defending its patent portfolio. Investors should monitor these proceedings closely, as adverse outcomes could impact Axsome's market position. Overall, this settlement is a positive legal development, providing a clear timeline and reducing litigation risk.
The settlement agreement with Unichem Laboratories has significant implications for Axsome Therapeutics' position in the central nervous system (CNS) disorder treatment market. Sunosi is a unique product in Axsome's portfolio, addressing excessive daytime sleepiness in adult patients with narcolepsy or obstructive sleep apnea. By blocking generic competition until 2042, Axsome retains a competitive edge in this niche market for an extended period. This exclusivity can lead to sustained market penetration and brand loyalty among prescribers and patients.
For retail investors, it's important to note that such settlements also reflect the strength of Axsome's patent strategy and its ability to safeguard its intellectual property. While the settlement reduces immediate competitive threats, the ongoing litigation with other parties remains a potential risk factor. Long-term investors should consider the broader implications of Axsome's legal strategy on its market positioning.
NEW YORK, June 05, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM) (Axsome), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system disorders, today announced that it has entered into a settlement agreement with Unichem Laboratories Ltd. (Unichem) resolving patent litigation related to Axsome’s product Sunosi® (solriamfetol). The litigation, which is pending in the United States District Court for the District of New Jersey, resulted from submission by Unichem of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic equivalent of Sunosi in the United States. The settlement agreement permits Unichem to begin selling its generic version of Sunosi on June 30, 2042, or earlier under certain circumstances. The June 30, 2042 date is also subject to potential extension for pediatric exclusivity.
As required by law, Axsome and Unichem will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. Similar patent litigation brought by Axsome against other parties remains pending in the U.S. District Court for the District of New Jersey.
About Axsome Therapeutics, Inc.
Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for central nervous system (CNS) conditions that have limited treatment options. Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions. At Axsome, we are committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians. For more information, please visit the Company’s website at axsome.com. The Company may occasionally disseminate material, nonpublic information on the company website.
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the continued commercial success of our Sunosi® (“SUNOSI”) and Auvelity® (“AUVELITY”) products and the success of our efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, our product candidates, including statements regarding the timing of any NDA submission; whether issues identified by FDA in the complete response letter may impact the potential approvability of the Company’s NDA for AXS-07 for the acute treatment of migraine in adults with or without aura, pursuant to our special protocol assessment for the MOMENTUM clinical trial; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the continued commercialization of SUNOSI and AUVELITY and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; unforeseen circumstances or other disruptions to normal business operations arising from or related to geopolitical conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance.
Axsome Contacts:
Investors:
Mark Jacobson
Chief Operating Officer
Axsome Therapeutics, Inc.
One World Trade Center, 22nd Floor
New York, NY 10007
Tel: 212-332-3243
Email: mjacobson@axsome.com
www.axsome.com
Media:
Darren Opland
Director, Corporate Communications
Axsome Therapeutics, Inc.
One World Trade Center, 22nd Floor
New York, NY 10007
Tel: 929-837-1065
Email: dopland@axsome.com
www.axsome.com
FAQ
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