Deuruxolitinib phosphate - Generic Drug Details

What are the generic sources for deuruxolitinib phosphate and what is the scope of freedom to operate?

Deuruxolitinib phosphate is the generic ingredient in one branded drug marketed by Sun Pharm Inds Inc and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Deuruxolitinib phosphate has twenty-four patent family members in thirteen countries.

Summary for deuruxolitinib phosphate

International Patents:	24
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	2
DailyMed Link:	deuruxolitinib phosphate at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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.

Recent Clinical Trials for deuruxolitinib phosphate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Concert Pharmaceuticals	Phase 1

See all deuruxolitinib phosphate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for deuruxolitinib phosphate

D11AH	Agents for dermatitis, excluding corticosteroids
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

L01EJ	Janus-associated kinase (JAK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for deuruxolitinib phosphate

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
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

International Patents for deuruxolitinib phosphate

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

Deuruxolitinib phosphate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Deuruxolitinib Phosphate

Introduction

Deuruxolitinib phosphate, marketed as LEQSELVI, is a groundbreaking drug developed by Sun Pharmaceutical Industries for the treatment of moderate to severe alopecia areata. This oral medication has recently received FDA approval, marking a significant milestone in the treatment of this inflammatory disorder.

Market Need and Demand

Alopecia areata, a condition characterized by hair loss, lacks a cure and has limited treatment options. The approval of deuruxolitinib phosphate fills a critical gap in the market, offering patients a new and effective treatment option. The demand for this drug is expected to be high due to the lack of satisfactory treatments currently available[2].

Competitive Landscape

The market for alopecia areata treatments is relatively niche but growing. Deuruxolitinib phosphate enters a landscape where other JAK inhibitors, such as baricitinib, are already present. However, its approval as a first-line treatment positions it favorably, offering patients and healthcare providers an additional and potentially more effective option[2].

Clinical Efficacy and Safety

The drug's efficacy was demonstrated in the THRIVE-AA1 and THRIVE-AA2 clinical trials, where patients showed significant hair regrowth, including scalp, eyebrow, and eyelash regrowth. These trials also highlighted the safety profile of deuruxolitinib phosphate, with the 8 mg and 12 mg twice-daily doses meeting primary efficacy endpoints and showing favorable safety outcomes[2].

Revenue Projections

According to GlobalData's Expiry Model, the revenue for deuruxolitinib phosphate is projected to reach an annual total of $257 million by 2033 in the US. This forecast is based on the drug's phase transition success rates, remaining R&D costs, and the likelihood of approval and sales-related costs[1].

Risk-Adjusted Net Present Value (rNPV)

The risk-adjusted NPV model is a conservative valuation measure that accounts for the risks associated with drug development. For deuruxolitinib phosphate, this model considers the phase transition success rates and the likelihood of approval to provide a comprehensive valuation. This approach helps investors and stakeholders understand the potential financial returns while factoring in the inherent risks of clinical development[1].

Financial Performance of Sun Pharmaceutical Industries

Sun Pharmaceutical Industries, the developer of deuruxolitinib phosphate, reported revenues of INR484,968.5 million for the fiscal year ended March 2024, representing a 10.5% increase over the previous year. The company's operating margin was 20.5%, and the net margin was 19.7% for the same period. The approval and subsequent market performance of deuruxolitinib phosphate are expected to contribute positively to the company's financial trajectory[1].

Market Drivers

Several factors drive the market for deuruxolitinib phosphate:

• Unmet Medical Need: The lack of effective treatments for alopecia areata creates a significant demand for new therapies.
• Clinical Efficacy: The drug's proven efficacy in clinical trials enhances its market appeal.
• Regulatory Approval: FDA approval as a first-line treatment boosts its market position.
• Patient and Physician Acceptance: Positive feedback from patients and healthcare providers can drive adoption rates[2].

Challenges and Restraints

Despite the positive outlook, there are challenges to consider:

• Competition: Other JAK inhibitors and potential future treatments could compete for market share.
• Regulatory Scrutiny: Continuous monitoring by regulatory bodies can impact the drug's long-term market presence.
• Side Effects and Safety Concerns: Any adverse events or safety issues could affect patient compliance and market growth[2].

Future Research Directions

The success of deuruxolitinib phosphate may inform future research directions for alopecia areata treatments. The focus on quantitative measures such as eyebrow and eyelash growth, in addition to scalp hair regrowth, provides a more comprehensive understanding of treatment efficacy. This could lead to further innovations and additional treatment options for patients[2].

Key Takeaways

• Market Need: Deuruxolitinib phosphate addresses a significant unmet medical need in the treatment of alopecia areata.
• Revenue Projections: Projected annual revenue of $257 million by 2033 in the US.
• Risk-Adjusted NPV: A conservative valuation approach considering phase transition success rates and approval likelihood.
• Financial Impact: Expected to positively contribute to Sun Pharmaceutical Industries' financial performance.
• Market Drivers: Unmet medical need, clinical efficacy, regulatory approval, and patient/physician acceptance.
• Challenges: Competition, regulatory scrutiny, and potential side effects.

FAQs

Q1: What is deuruxolitinib phosphate used for? Deuruxolitinib phosphate is used for the treatment of moderate to severe alopecia areata, an inflammatory disorder characterized by hair loss.

Q2: How was deuruxolitinib phosphate approved? Deuruxolitinib phosphate was approved by the FDA based on the results of the THRIVE-AA1 and THRIVE-AA2 clinical trials, which demonstrated its efficacy and safety.

Q3: What are the projected revenues for deuruxolitinib phosphate? The projected annual revenue for deuruxolitinib phosphate is $257 million by 2033 in the US, according to GlobalData's Expiry Model.

Q4: What are the key drivers for the market success of deuruxolitinib phosphate? The key drivers include unmet medical need, clinical efficacy, FDA approval as a first-line treatment, and patient and physician acceptance.

Q5: What challenges might deuruxolitinib phosphate face in the market? Challenges include competition from other JAK inhibitors, regulatory scrutiny, and potential side effects or safety concerns.

Cited Sources

1. Pharmaceutical Technology: "Risk Adjusted Net Present Value: What is the current valuation of Deuruxolitinib Phosphate?"
2. AJMC: "FDA Approves Deuruxolitinib for Alopecia Areata"
3. AdisInsight - Springer: "Deuruxolitinib - Concert Pharmaceuticals"
4. GlobeNewswire: "Phosphate Market Forecast Report 2024-2029"
5. FDA: "217900Orig1s000 - LEQSELVI™ (deuruxolitinib) tablets, for oral use"