Sun Pharmaceutical Industries Limited (Sun Pharma) has made two significant announcements regarding its novel drug LEQSELVI™ (deuruxolitinib), marking important milestones for the company's dermatology portfolio.

Settlement with Incyte Corporation

Sun Pharma has reached a settlement and license agreement with Incyte Corporation, resolving the ongoing litigation related to LEQSELVI™. As part of the agreement:

• Both parties will seek dismissal of the pending litigation in the United States District Court for the District of New Jersey.
• Incyte has granted Sun Pharma a limited, non-exclusive license to U.S. Patent Nos. 9,662,335 and certain related patents for oral deuruxolitinib in specific non-hematology-oncology indications, including alopecia areata, in the United States.
• Sun Pharma will make upfront and ongoing royalty payments to Incyte until the expiry of the patents.

The specific financial terms of the settlement remain confidential.

US Launch of LEQSELVI™

Sun Pharma has launched LEQSELVI™ (deuruxolitinib) in the United States for the treatment of adults with severe alopecia areata. Key points of the launch include:

• LEQSELVI™ is now available for prescription nationwide, offering a new treatment option for eligible patients.
• The drug is an oral selective inhibitor of Janus kinases JAK1 and JAK2.
• In clinical trials, LEQSELVI™ demonstrated rapid and significant results:
  • One-third of patients regained almost all of their hair by Week 24.
  • Some patients (3%) achieved 80% or more scalp coverage as fast as 8 weeks.

Richard Ascroft, CEO of Sun Pharma North America, stated, "The launch of LEQSELVI in the U.S. brings an effective, new treatment option for severe alopecia areata to eligible patients and the healthcare providers who treat them."

About Alopecia Areata

Alopecia areata is an autoimmune disease causing partial or complete hair loss on the scalp and body. It affects up to 2.50% of the United States and global population during their lifetime, with significant psychological impacts on patients.

Patient Support Program

Sun Pharma has introduced the LEQSELVI SUPPORT™ Program to enhance accessibility:

• Eligible patients can receive their medication for as little as $0 for up to two years.
• The program provides access to a dedicated Patient Access Liaison for personalized support.

Safety Information

While LEQSELVI™ offers new hope for alopecia areata patients, it comes with important safety considerations. The drug may cause serious side effects, including infections, malignancies, thrombosis, and gastrointestinal perforations. Patients and healthcare providers are advised to review the full prescribing information, including boxed warnings.

These developments represent significant progress in Sun Pharma's specialty pharmaceutical portfolio, particularly in the dermatology segment. The resolution of the patent litigation and the subsequent launch of LEQSELVI™ in the US market position Sun Pharma to potentially capture a significant share in the treatment of severe alopecia areata.

Sun Pharmaceutical Industries Limited , a leading global specialty generic pharmaceutical company, has made significant strides in its US operations with two major announcements on July 14, 2025.

LEQSELVI™ Launch in the US

Sun Pharma has officially launched LEQSELVI™ (deuruxolitinib) 8 mg tablets in the United States for the treatment of adults with severe alopecia areata. This launch marks a crucial milestone for the company's dermatology portfolio and offers a new treatment option for patients suffering from this autoimmune condition.

Key highlights of LEQSELVI™:

• Indicated for adults with severe alopecia areata
• Demonstrated rapid results in clinical trials, with one-third of patients regaining almost all their hair by Week 24
• Some patients (3%) achieved 80% or more scalp coverage as fast as 8 weeks
• Available nationwide for prescription

Richard Ascroft, CEO of Sun Pharma North America, emphasized the importance of this launch, stating, "The launch of LEQSELVI in the U.S. brings an effective, new treatment option for severe alopecia areata to eligible patients and the healthcare providers who treat them."

To support patient access, Sun Pharma has introduced the LEQSELVI SUPPORT™ Program, offering eligible patients the opportunity to receive their medication for as little as $0 for up to two years.

Settlement with Incyte Corporation

In a separate development, Sun Pharma announced a settlement and license agreement with Incyte Corporation regarding litigation related to LEQSELVI™. The agreement includes:

• Dismissal of pending LEQSELVI litigation in the United States District Court for the District of New Jersey
• Mutual release of all claims raised or that could have been raised in the litigation
• Incyte granting Sun a limited, non-exclusive license to certain US patents for oral deuruxolitinib in specific non-hematology-oncology indications, including alopecia areata
• Sun agreeing to pay Incyte an upfront amount and ongoing royalty payments until the expiry of the patents

This settlement resolves the patent dispute between the two companies, paving the way for Sun Pharma to proceed with the commercialization of LEQSELVI™ in the US market.

Impact on Sun Pharma's US Business

These developments are expected to strengthen Sun Pharma's position in the US pharmaceutical market, particularly in the dermatology segment. The company is already ranked 2nd by prescriptions in the US dermatology market and is the 12th largest generics company in the US.

Sun Pharma's US formulations business accounted for 31% of its total sales in FY25, generating revenues of Rs 162,403.00 million. The launch of LEQSELVI™ and the resolution of the patent dispute with Incyte are likely to contribute positively to the company's US operations and overall growth strategy.

As Sun Pharma continues to focus on enhancing its share of innovative and branded business in the US, these recent developments align well with the company's strategic objectives. The successful launch and commercialization of LEQSELVI™ could potentially boost Sun Pharma's specialty sales, which already account for over 18% of the company's global sales.

With these advancements, Sun Pharma reinforces its commitment to addressing unmet medical needs and expanding its presence in the lucrative US pharmaceutical market.