LEQSELVI Drug Patent Profile

When do Leqselvi patents expire, and what generic alternatives are available?

Leqselvi is a drug marketed by Sun Pharm Inds Inc and is included in one NDA. There are three patents protecting this drug.

This drug has twenty-four patent family members in thirteen countries.

The generic ingredient in LEQSELVI is deuruxolitinib phosphate. Additional details are available on the deuruxolitinib phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Leqselvi

Leqselvi will be eligible for patent challenges on July 25, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 25, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LEQSELVI

International Patents:	24
US Patents:	3
Applicants:	1
NDAs:	1
DailyMed Link:	LEQSELVI at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LEQSELVI

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

217900

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for LEQSELVI

LEQSELVI is protected by three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Inc	LEQSELVI	deuruxolitinib phosphate	TABLET;ORAL	217900-001	Jul 25, 2024		RX	Yes	Yes			Y
Sun Pharm Inds Inc	LEQSELVI	deuruxolitinib phosphate	TABLET;ORAL	217900-001	Jul 25, 2024		RX	Yes	Yes
Sun Pharm Inds Inc	LEQSELVI	deuruxolitinib phosphate	TABLET;ORAL	217900-001	Jul 25, 2024		RX	Yes	Yes
Sun Pharm Inds Inc	LEQSELVI	deuruxolitinib phosphate	TABLET;ORAL	217900-001	Jul 25, 2024		RX	Yes	Yes

International Patents for LEQSELVI

When does loss-of-exclusivity occur for LEQSELVI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Eurasian Patent Organization

European Patent Office

Japan

Mexico

South Korea

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LEQSELVI around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20190003711	중수소화된 JAK 저해제를 이용한 탈모 장애의 치료
Japan	7145080
Brazil	112018072339	tratamento de distúrbios de perda de cabelo com inibidores de jak deuterados
Mexico	2023002324	TRATAMIENTO DE TRASTORNOS DE PERDIDA DE CABELLO CON INHIBIDORES DE CINASAS ASOCIADAS A JANUS (JAK) DEUTERADOS. (TREATMENT OF HAIR LOSS DISORDERS WITH DEUTERATED JAK INHIBITORS.)
Japan	2022171838	重水素化ＪＡＫ阻害剤による脱毛障害の処置

LEQSELVI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Leqselvi

Introduction to Leqselvi

Leqselvi, a drug developed by Sun Pharma for the treatment of alopecia areata, an autoimmune disease causing hair loss, has been at the center of significant market and financial discussions. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

FDA Approval and Market Potential

Leqselvi received approval from the US Food and Drug Administration (FDA) in July 2024, marking a crucial milestone in its journey to the market. Market analysts had high expectations for the drug, anticipating it to contribute $90 million in sales for FY26 and $125 million for FY27, with projected earnings per share (EPS) gains of 5-8% over these years[1][4].

Legal Roadblocks and Patent Disputes

However, the launch of Leqselvi has been put on hold due to a patent infringement lawsuit filed by Incyte Corporation. The US District Court of New Jersey granted a preliminary injunction in favor of Incyte, delaying Sun Pharma's planned US launch. This decision has significant implications for Sun Pharma's financial projections and market strategy[1][4][5].

Impact on Sun Pharma’s Financials

The delay in the launch of Leqselvi is expected to impact Sun Pharma’s near-term earnings. According to Citi Research, the delay could reduce Sun Pharma’s EPS by 3-6% in the near term. Additionally, the company’s stock price fell by 2.68% to Rs 1,808.95 following the court’s decision, reflecting investor concerns about the drug’s delayed launch[1][4].

Projected Revenue and Earnings

Despite the delay, global brokerage firms have made adjusted projections. Nomura assumes a Leqselvi launch in FY25 and has factored in projected revenues of $10 million, $80 million, and $150 million in FY25F, FY26F, and FY27F, respectively. The estimated earnings impact from the product is 0.4%, 3.1%, and 5.2% in these respective financial years[4].

Competitive Positioning

The delay in Leqselvi’s launch also affects its competitive positioning. Rival drugs will have longer-term clinical data by the time Leqselvi reaches the market, potentially giving them an edge in terms of market acceptance and patient preference. This could further complicate Sun Pharma’s efforts to regain lost ground once the drug is finally launched[4].

Appeal and Negotiation

Sun Pharma has expressed its disagreement with the court’s decision and intends to appeal immediately. The company may also consider negotiating a settlement with Incyte, which could involve royalty payments in exchange for an earlier launch date. This negotiation process will be crucial in determining the future trajectory of Leqselvi[1][4].

Financial Performance of Sun Pharma

Despite the challenges with Leqselvi, Sun Pharma posted strong earnings for the July-September quarter, with a net profit rise of 28% year-on-year to ₹3,040 crore and a 9% growth in consolidated revenue from operations to ₹13,291 crore. This robust financial performance provides a cushion against the immediate impact of the Leqselvi delay[5].

Analyst Ratings and Recommendations

Following the court’s decision, Elara Capital downgraded Sun Pharma to “Reduce” with a target price of Rs 1,871. Nomura maintained a 'neutral' rating with a price target of ₹1,850 per share. These ratings reflect the mixed sentiments among analysts regarding the impact of the Leqselvi delay on Sun Pharma’s overall performance[1][4].

Long-Term Implications

The long-term implications of the Leqselvi delay are significant. If Sun Pharma loses the appeal, the launch could be deferred up to two years, severely impacting the drug’s market potential and the company’s financial projections. However, if the appeal is successful, the launch could be delayed by only a few months, mitigating some of the financial and market impacts[1].

Key Takeaways

• Delayed Launch: The launch of Leqselvi has been delayed due to a patent infringement lawsuit, impacting Sun Pharma’s financial projections.
• Financial Impact: The delay is expected to reduce Sun Pharma’s EPS by 3-6% in the near term and affect its competitive positioning.
• Projected Revenues: Adjusted revenue projections for Leqselvi include $10 million, $80 million, and $150 million in FY25F, FY26F, and FY27F, respectively.
• Appeal and Negotiation: Sun Pharma is appealing the court’s decision and may negotiate a settlement with Incyte.
• Overall Financial Performance: Despite the Leqselvi delay, Sun Pharma’s overall financial performance remains strong.

FAQs

Q: What is Leqselvi and what is it used for? A: Leqselvi is a drug developed by Sun Pharma for the treatment of alopecia areata, an autoimmune disease that causes hair loss.

Q: Why has the launch of Leqselvi been delayed? A: The launch has been delayed due to a patent infringement lawsuit filed by Incyte Corporation, resulting in a preliminary injunction granted by the US District Court of New Jersey.

Q: How will the delay impact Sun Pharma’s financials? A: The delay is expected to reduce Sun Pharma’s EPS by 3-6% in the near term and affect its competitive positioning in the market.

Q: What are the projected revenues for Leqselvi? A: Adjusted revenue projections include $10 million, $80 million, and $150 million in FY25F, FY26F, and FY27F, respectively.

Q: What steps is Sun Pharma taking to address the delay? A: Sun Pharma is appealing the court’s decision and may negotiate a settlement with Incyte to secure an earlier launch date.

Sources:

1. Business Standard: Sun Pharma's Leqselvi launch in US faces legal roadblock; analysts cautious[1].
2. Investing.com: Earnings call: Trevi Therapeutics reports Q3 2024 financials, clinical updates[2].
3. NBER: The Economics of Drug Development: Pricing and Innovation in a Changing Market[3].
4. CNBC TV18: Sun Pharma shares fall 5% post Leqselvi injunction, but analysts say opportunity not over[4].
5. 5paisa: Sun Pharma Shares Price Fall 5% on Court Injunction Blocking Leqselvi Launch[5].