Sun Pharma Clears Legal Hurdle for LEQSELVI Launch in US

Sun Pharmaceutical Industries Limited has achieved a critical legal victory in its ongoing battle concerning the launch of its product, LEQSELVI (deuruxolitinib), in the United States. 

This comes following a ruling from the U.S. Court of Appeals for the Federal Circuit, which lifted a previously imposed preliminary injunction. The decision removes legal barriers that had delayed the company’s product rollout. While the primary litigation with Incyte Corporation is yet to be resolved, this interim judgment marks a turning point for the pharmaceutical giant.

Court Ruling Favouring Sun Pharma

On April 9, 2025, an oral argument was presented before the U.S. Court of Appeals for the Federal Circuit regarding Sun Pharma’s appeal against the District Court of New Jersey’s earlier decision. That decision had enforced a preliminary injunction that prevented the company from launching LEQSELVI  in the U.S. market. 

However, following the hearing, the Federal Circuit issued a favourable ruling, vacating the injunction with immediate effect. This legal development now enables Sun Pharma to proceed with its commercial plans for LEQSELVI, free from judicial restrictions.

The preliminary injunction was a significant obstacle, initially brought about by litigation initiated by Incyte Corporation. With the court now vacating the order, Sun Pharma is legally positioned to prepare for the launch of its product in the competitive U.S. pharmaceutical landscape.

Next Steps and Strategic Implications

Although the preliminary injunction is no longer in effect, Sun Pharma has indicated that the broader legal proceedings with Incyte Corporation are still in progress. The company has reassured stakeholders that it will announce its launch strategy for LEQSELVI in due course.

This development underscores the importance of navigating regulatory and legal frameworks efficiently, especially in highly competitive sectors such as biopharmaceuticals. Sun Pharma’s ability to clear this hurdle not only demonstrates its legal preparedness but also signals confidence in its pipeline and product portfolio.

Sun Pharma Share Performance 

As of April 11, 2025, at 11:30 AM, Sun Pharma Share Price is trading at ₹1,690.60 per share, reflecting a profit of 2.32% from the previous closing price. Over the past month, the stock has registered a surge of 2.13%.

Conclusion

The U.S. Court of Appeals’ decision to lift the injunction marks a significant milestone for Sun Pharmaceutical Industries. While the legal dispute with Incyte Corporation is not yet concluded, this ruling allows Sun Pharma to move forward with launching LEQSELVI, reinforcing its position in the U.S. market. The company’s next steps will be closely watched as it transitions from litigation to commercial execution.

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