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.

Sun Pharmaceutical Industries Limited has announced the launch of LEQSELVI™ (deuruxolitinib) in the United States market, marking a significant milestone in the treatment of severe alopecia areata. This new drug offering represents an important addition to Sun Pharma's dermatology portfolio and addresses a critical unmet need in the alopecia areata community.

A New Hope for Alopecia Areata Patients

LEQSELVI, an oral selective inhibitor of Janus kinases JAK1 and JAK2, is now available for prescription nationwide in the U.S. The drug is specifically indicated for the treatment of adults with severe alopecia areata, an autoimmune disease that can result in partial or complete loss of hair on the scalp and body.

Rapid and Significant Results

Clinical trials have demonstrated LEQSELVI's efficacy, with notable results observed as early as 8 weeks into treatment:

• One-third of patients regained almost all of their hair by Week 24
• Some patients (3%) achieved 80% or more scalp coverage in as little as 8 weeks

Addressing a Significant Market Need

Alopecia areata affects up to 2.50% of the United States and global population during their lifetime. The launch of LEQSELVI provides a new treatment option for eligible patients and healthcare providers in a field with limited alternatives.

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."

Expert and Patient Advocacy Support

The medical community has responded positively to LEQSELVI's introduction. Dr. Arash Mostaghimi, Vice Chair of Clinical Trials and Innovation and Associate Professor of Dermatology at Brigham and Women's Hospital, commented on the drug's compelling clinical evidence and consistent efficacy.

Nicole Friedland, President and CEO of the National Alopecia Areata Foundation (NAAF), expressed optimism about LEQSELVI's availability, highlighting its potential to bring hope to the alopecia areata community.

Patient Access and Support

Sun Pharma has introduced the LEQSELVI SUPPORT™ Program to enhance accessibility for patients. This program offers eligible individuals the opportunity to receive their medication for as little as $0 for up to two years, along with dedicated support from Patient Access Liaisons.

Safety Considerations

As with any medication, LEQSELVI comes with potential side effects. The most common adverse events reported in placebo-controlled trials were headache, acne, and nasopharyngitis. Healthcare providers and patients are advised to review the full prescribing information, including boxed warnings, before starting treatment.

Settlement with Incyte Corporation

In a related development, Sun Pharma has reached a settlement and license agreement with Incyte Corporation regarding litigation related to LEQSELVI. The agreement includes a limited, non-exclusive license for Sun Pharma to use certain patents for oral deuruxolitinib in specific non-hematology-oncology indications, including alopecia areata, in the U.S.

The launch of LEQSELVI represents a significant step forward in Sun Pharma's commitment to addressing unmet medical needs and expanding its presence in the U.S. pharmaceutical market. As the drug becomes available to patients nationwide, it has the potential to make a meaningful impact on the lives of those affected by severe alopecia areata.