New Delhi (April 10, 2025) – Sun Pharmaceutical Industries Ltd. announced Thursday that a U.S. court has ruled in its favor, promptly vacating a preliminary injunction that had restricted the launch of LEQSELVI (deuruxolitinib) in the united States. LEQSELVI is a drug developed to treat alopecia areata, an autoimmune disorder characterized by patchy hair loss. This favorable ruling marks a significant step forward for Sun Pharma in bringing this treatment to the millions of Americans affected by the condition.

The legal battle stemmed from a patent infringement claim filed by Incyte Corporation, who alleged that LEQSELVI infringed on thier existing intellectual property. The dispute centered around the composition and use of deuruxolitinib, the active ingredient in Sun Pharma’s drug.

According to a regulatory filing by Sun Pharma, “Shortly after the oral argument concluded, the US Court of Appeals for the Federal Circuit ruled in favour of the company and vacated the preliminary injunction effective immediately.” This decision effectively removes the immediate barrier to launching LEQSELVI in the U.S. market.

The U.S. Court of Appeals for the Federal Circuit heard oral arguments on April 9, 2025, regarding Sun Pharma’s appeal of a previous decision by the U.S. District Court for the District of New Jersey. The District Court had initially granted a preliminary injunction that delayed the launch of LEQSELVI. The appellate court’s swift reversal following the oral arguments suggests a strong disagreement with the lower court’s reasoning.

While the overall litigation between Incyte Corporation and Sun Pharma is ongoing, this ruling provides Sun Pharma with the freedom to proceed with its launch plans. “The company is no longer under a court order that delays or restricts the company from launching LEQSELVI,” the filing stated. “The company will disclose LEQSELVI launch plans in due course of time.”

Understanding Alopecia Areata

Alopecia areata affects millions of Americans,causing significant emotional distress and impacting quality of life. The condition is characterized by the immune system attacking hair follicles, leading to hair loss on the scalp and other parts of the body. While the exact cause is unknown,genetic predisposition and environmental factors are believed to play a role.

Currently available treatments for alopecia areata offer varying degrees of success. Corticosteroids,both topical and injected,are commonly used to suppress the immune system locally. Other options include minoxidil, a topical solution that can stimulate hair growth, and light therapy. Though, these treatments are not effective for everyone, and new therapies are urgently needed.

* Facts regarding LEQSELVI’s efficacy and side effects will become available upon the drug’s launch and further clinical data.

The Significance of the Court’s Decision

The court’s decision to vacate the preliminary injunction is significant for several reasons:

• Access to Treatment: It perhaps opens the door for American patients to access a new treatment option for alopecia areata. The availability of LEQSELVI could offer hope to individuals who have not responded well to existing therapies.
• Market Competition: The introduction of LEQSELVI into the U.S. market could increase competition and potentially drive down the cost of treatment for alopecia areata. This is especially relevant in the U.S. healthcare system, where drug prices are often a major concern.
• innovation: The ruling encourages pharmaceutical companies to continue investing in research and development of new treatments for autoimmune disorders. It demonstrates that the legal system can support innovation by ensuring fair competition.

The legal battle highlights the complexities of patent law and the importance of protecting intellectual property while also ensuring that patients have access to innovative treatments. The balance between these competing interests is crucial for fostering a healthy pharmaceutical industry and improving patient outcomes.

Looking Ahead: What’s Next for Sun Pharma and LEQSELVI?

Sun Pharma has stated that it will announce its launch plans for LEQSELVI “in due course of time.” Several factors will likely influence the timing of the launch, including:

• Ongoing Litigation: While the preliminary injunction has been lifted, the underlying patent infringement lawsuit with Incyte Corporation is still ongoing. Sun Pharma will need to continue to defend its position in court.
• Regulatory Approval: LEQSELVI will likely need to undergo further regulatory review by the FDA before it can be widely marketed in the U.S.
• Manufacturing and Distribution: Sun Pharma will need to ensure that it has sufficient manufacturing capacity and distribution channels in place to meet the expected demand for LEQSELVI.
• Marketing and Education: Sun Pharma will need to educate healthcare providers and patients about the benefits and risks of LEQSELVI. This will involve conducting clinical trials, publishing research results, and developing marketing materials.

For U.S. patients with alopecia areata,the court’s decision offers a glimmer of hope. If LEQSELVI proves to be a safe and effective treatment, it could significantly improve their quality of life. The coming months will be crucial as Sun Pharma moves towards launching the drug in the U.S.market.