Supernus Wins Infringement and Validity Case on Trokendi XR® against Torrent

Rhea-AI Summary

Supernus Pharmaceuticals, Inc. has won a legal battle against Torrent Pharmaceuticals Ltd. and its subsidiary, Torrent Pharma Inc., regarding the infringement of three U.S. patents related to Trokendi XR®. The United States District Court for the District of New Jersey ruled in favor of Supernus, affirming the validity of the patents and the infringement by Torrent. This ruling prevents Torrent from marketing a generic version of Trokendi XR® before the expiration of Supernus' patents, securing the company's intellectual property rights and market exclusivity. Jack A. Khattar, President and CEO of Supernus Pharmaceuticals, expressed satisfaction with the court's decision, emphasizing the significance of protecting their patented products.

Positive

• Supernus Pharmaceuticals successfully defended its patents against infringement by Torrent Pharmaceuticals, ensuring market exclusivity for Trokendi XR®.
• The ruling affirms the validity of Supernus' patents and prevents Torrent from marketing a generic version of Trokendi XR® before the patents' expiration.
• Jack A. Khattar, President and CEO of Supernus Pharmaceuticals, expressed satisfaction with the court's decision, highlighting the importance of protecting the company's intellectual property.

Negative

• None.

Legal Expert

The recent court ruling in favor of Supernus Pharmaceuticals regarding patent infringement by Torrent Pharmaceuticals is a significant legal victory that underscores the importance of intellectual property rights within the pharmaceutical industry. The upheld patents protect Supernus's proprietary drug Trokendi XR^®, which is a key product in their portfolio for treating central nervous system diseases.

This legal determination not only serves as a deterrent against future infringement attempts by competitors but also solidifies Supernus's market exclusivity for Trokendi XR^® until the patents expire. Such exclusivity can translate into sustained revenue streams and potentially higher profit margins due to the lack of generic competition. The court's decision may also influence the strategies of other pharmaceutical companies, reinforcing the need for rigorous patent protection and careful consideration of patent life-cycle management.

Financial Analyst

The ruling's impact on Supernus Pharmaceuticals' financials could be profound. By preventing the early entry of a generic version of Trokendi XR^®, Supernus is likely to maintain its pricing power and market share for a longer period. Investors often closely monitor patent litigation outcomes because of their direct correlation with a company's future revenue and earnings potential.

From a stock market perspective, such positive legal outcomes can lead to investor optimism, potentially boosting the company's stock price. It's important to note that the pharmaceutical sector is highly sensitive to patent cliffs—the expiration of patents leading to a sudden drop in revenues. Hence, the extension of market exclusivity can provide Supernus with a strategic advantage, allowing for more time to diversify its product line or invest in new research and development initiatives without the immediate pressure of lost revenues from a flagship product.

Pharmaceutical Market Analyst

The broader implications for the pharmaceutical market include the reaffirmation of patent strength as a critical factor in maintaining competitive advantage. The ruling may prompt other generic manufacturers to approach patent challenges with greater caution, potentially reducing the number of patent litigations in the industry.

Moreover, the decision highlights the significance of ANDA litigation under the Hatch-Waxman Act, which balances the innovation incentives for brand-name drug companies with the introduction of lower-cost generic drugs. The outcome of such cases can significantly alter market dynamics, influencing the strategies of both brand-name and generic pharmaceutical companies. Market exclusivity periods are pivotal for the return on investment in drug development, which is known for its high costs and risks. The reaffirmation of Supernus's patents serves as a testament to the legal mechanisms in place to protect such investments.

ROCKVILLE, Md., Feb. 05, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced today that the United States District Court for the District of New Jersey ruled that Torrent Pharmaceuticals Ltd. and its subsidiary, Torrent Pharma Inc., infringed U.S. Patent Nos. 8,992,989; 9,549,940; and 9,622,983 by submitting to the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) seeking permission to market a generic version of Trokendi XR® before the expiration of Supernus’ patents.

“We are very pleased with the District Court’s ruling that Torrent infringed our Trokendi XR® patents and the reaffirmation of the validity of those patents,” stated Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. “We are very serious about securing intellectual property (IP) protection for our innovative products and about vigorously enforcing such IP rights even if the product is at a later stage in its lifecycle.”

In addition to the three patents that were the subject of the District Court’s decision, Trokendi XR® is further protected by seven other patents. The Orange Book lists a total of ten patents as covering Trokendi XR.

About Supernus Pharmaceuticals, Inc.

Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.

Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, ADHD, hypomobility in Parkinson's disease (PD), cervical dystonia, chronic sialorrhea, dyskinesia in PD patients receiving levodopa-based therapy, and drug-induced extrapyramidal reactions in adult patients. We are developing a broad range of novel CNS product candidates including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders.

For more information, please visit www.supernus.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company’s ability to sustain and increase its profitability; the Company’s ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company’s corporate strategy; the Company’s future financial performance and projected expenditures; the Company’s ability to increase the number of prescriptions written for each of its products and the products of its subsidiaries; the Company’s ability to increase its net revenue; the Company’s ability to commercialize its products and the products of its subsidiaries; the Company’s ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company’s product research and development activities, including the timing and progress of the Company’s clinical trials, and projected expenditures; the Company’s ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company’s product candidates; the Company’s ability to protect its intellectual property and the intellectual property of its subsidiaries and operate its business without infringing upon the intellectual property rights of others; the Company’s expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company’s product candidates; the accuracy of the Company’s estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company’s ability to increase its manufacturing capabilities for its products and product candidates; the Company’s projected markets and growth in markets; the Company’s product formulations and patient needs and potential funding sources; the Company’s staffing needs; the Company’s ability to increase the number of prescriptions written for each of its products and the products of its subsidiaries; the Company’s ability to increase its net revenue from its products and the products of its subsidiaries; and other risk factors set forth from time to time in the Company’s filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events.

CONTACTS:

Jack A. Khattar, President and CEO
Timothy C. Dec, Senior Vice President and CFO
Supernus Pharmaceuticals, Inc.
Tel: (301) 838-2591

Or

INVESTOR CONTACT:

Peter Vozzo
ICR Westwicke
Office: (443) 213-0505
Email: peter.vozzo@westwicke.com 

What is the significance of the United States District Court's ruling for Supernus Pharmaceuticals (SUPN)?

The ruling affirms the validity of Supernus' patents and prevents Torrent from marketing a generic version of Trokendi XR® before the expiration of Supernus' patents, ensuring market exclusivity for the company.

What patents were infringed by Torrent Pharmaceuticals Ltd. and its subsidiary, Torrent Pharma Inc.?

The U.S. Patent Nos. 8,992,989; 9,549,940; and 9,622,983 related to Trokendi XR® were infringed by Torrent, as ruled by the United States District Court for the District of New Jersey.

How did the court ruling impact Supernus Pharmaceuticals' intellectual property rights?

The court ruling secured Supernus' intellectual property rights by preventing Torrent from marketing a generic version of Trokendi XR® before the expiration of the company's patents, ensuring market exclusivity for the product.