JYLAMVO Drug Patent Profile

Which patents cover Jylamvo, and when can generic versions of Jylamvo launch?

Jylamvo is a drug marketed by Shorla and is included in one NDA. There are two patents protecting this drug.

This drug has twenty-three patent family members in eighteen countries.

The generic ingredient in JYLAMVO is methotrexate. There are twenty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the methotrexate profile page.

DrugPatentWatch^® Generic Entry Outlook for Jylamvo

Indicators of Generic Entry

Summary for JYLAMVO

International Patents:	23
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	137
Patent Applications:	4,397
Drug Prices:	Drug price information for JYLAMVO
What excipients (inactive ingredients) are in JYLAMVO?	JYLAMVO excipients list
DailyMed Link:	JYLAMVO at DailyMed

See drug prices for JYLAMVO

Pharmacology for JYLAMVO

Drug Class	Folate Analog Metabolic Inhibitor
Mechanism of Action	Folic Acid Metabolism Inhibitors

US Patents and Regulatory Information for JYLAMVO

JYLAMVO is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shorla	JYLAMVO	methotrexate	SOLUTION;ORAL	212479-001	Nov 29, 2022		RX	Yes	Yes	11,771,701		Y
Shorla	JYLAMVO	methotrexate	SOLUTION;ORAL	212479-001	Nov 29, 2022		RX	Yes	Yes	11,129,833		Y

EU/EMA Drug Approvals for JYLAMVO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Nordic Group B.V.	Nordimet	methotrexate	EMEA/H/C/003983 Nordimet is indicated for the treatment of:active rheumatoid arthritis in adult patients,polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate,moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, and severe psoriatic arthritis in adult patients, induction of remission in moderate steroid-dependent Crohn's disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate.	Authorised	no	no	no	2016-08-18
Therakind (Europe) Limited	Jylamvo	methotrexate	EMEA/H/C/003756 In rheumatological and dermatological diseasesActive rheumatoid arthritis in adult patients.Polyarthritic forms of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate.Severe, treatment-refractory, disabling psoriasis which does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet A radiation (PUVA) therapy and retinoids, and severe psoriatic arthritis in adult patients.In oncologyMaintenance treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over.	Authorised	no	no	no	2017-03-29

International Patents for JYLAMVO

See the table below for patents covering JYLAMVO around the world.

Country	Patent Number	Title	Estimated Expiration
Cyprus	1125033
Hong Kong	1243638	甲氨蝶呤製劑 (METHOTREXATE FORMULATION)
Canada	3002493	FORMULATION DE METHOTREXATE (METHOTREXATE FORMULATION)
Japan	2021138748	メトトレキサート製剤 (METHOTREXATE FORMULATION)
United Kingdom	201419261
Japan	2017533274	メトトレキサート製剤

JYLAMVO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for JYLAMVO

Introduction to JYLAMVO

JYLAMVO, the first and only oral methotrexate solution approved in the United States for adults, marks a significant milestone in the treatment of various cancers and autoimmune diseases. Developed and commercialized by Shorla Oncology, this innovative formulation has several key features that set it apart from traditional methotrexate treatments.

FDA Approval and Commercial Launch

JYLAMVO received FDA approval in November 2022 and was subsequently acquired by Shorla Oncology in October 2023. This approval and acquisition have paved the way for its commercial launch in the U.S. market, supported by EVERSANA, a comprehensive commercialization partner[1][4].

Market Need and Target Population

JYLAMVO addresses a critical need in the oncology market, particularly for patients who have difficulty swallowing pills. The solution is indicated for the treatment of acute lymphoblastic leukemia as part of a combination chemotherapy maintenance regimen, among other indications. This fills a gap in patient care, especially for those who require alternative treatment options[1][4].

Unique Features of JYLAMVO

• Palatable Taste: JYLAMVO has a sweet and palatable taste, making it more acceptable to patients who may struggle with traditional oral medications.
• Stability: The solution is stable at room temperature (68°F to 77°F) for 90 days and does not require refrigeration, enhancing its convenience and shelf life[1][4].

Commercialization Strategy

Shorla Oncology, in partnership with EVERSANA, has activated a robust commercialization strategy. This includes field deployment sales and training solutions, medical information, pharmacovigilance and quality services, revenue management, and patient services. The comprehensive support ensures that JYLAMVO reaches the target patient population effectively[1][4].

Financial Implications

The acquisition and commercial launch of JYLAMVO have significant financial implications for Shorla Oncology. Here are a few key points:

Funding and Investment

Shorla Oncology recently raised $35 million in Series B funding, which has enabled the company to accelerate the growth of its oncology portfolio. This funding is crucial for supporting the commercialization efforts of JYLAMVO and other pipeline products[2].

Market Expansion

The acquisition of JYLAMVO expands Shorla Oncology's portfolio and strengthens its presence in the U.S. market. This move aligns with the company's strategy to bring vital and effective therapies to patients in underserved oncology and autoimmune disease areas, potentially increasing revenue streams[3].

Revenue Projections

Given the unique features and the unmet need it addresses, JYLAMVO is expected to contribute significantly to Shorla Oncology's revenue. The growing demand for specialized oncology treatments in the U.S. market further supports the potential for strong financial performance.

Competitive Landscape

The methotrexate market, including injectable and oral formulations, is competitive. However, JYLAMVO's unique features, such as its palatable taste and stability at room temperature, position it favorably in the market. Shorla Oncology's focus on orphan and pediatric cancers, where existing treatments are limited or inadequate, also differentiates it from other players in the market[3].

Pipeline and Future Growth

Shorla Oncology has an advanced pipeline of oncology therapies, including two New Drug Applications (NDAs) currently under FDA review. The company's strategy to address unmet patient needs and its growing portfolio suggest a promising future for both JYLAMVO and other upcoming therapies. This pipeline growth is expected to further enhance the company's financial trajectory and market presence[2].

Patient Impact and Market Reception

The introduction of JYLAMVO has been well-received by both patients and healthcare providers. The solution's ease of use and palatable taste have been highlighted as significant advantages, particularly for patients who have struggled with traditional methotrexate formulations.

"We are delighted to introduce JYLAMVO as an alternative treatment option for patients who may have difficulty swallowing pills," said Sharon Cunningham, CEO of Shorla Oncology[4].

Regulatory Environment

The FDA's approval process and ongoing regulatory support are crucial for the success of JYLAMVO. The FDA's commitment to enhancing its review processes and ensuring the timely approval of critical therapies like JYLAMVO is vital for bringing new treatments to the market efficiently[5].

Key Takeaways

• Innovative Formulation: JYLAMVO is the first oral methotrexate solution approved for adults in the U.S., offering a sweet and palatable taste.
• Commercial Launch: Supported by EVERSANA, the commercial launch includes comprehensive services to ensure effective market penetration.
• Financial Implications: The acquisition and commercialization of JYLAMVO are supported by significant funding, positioning Shorla Oncology for revenue growth.
• Competitive Advantage: Unique features and a focus on unmet patient needs differentiate JYLAMVO in the competitive methotrexate market.
• Pipeline Growth: Shorla Oncology's advanced pipeline of oncology therapies indicates a promising future for the company.

FAQs

What is JYLAMVO, and how is it different from traditional methotrexate?

JYLAMVO is the first and only oral methotrexate solution approved in the U.S. for adults. It has a sweet and palatable taste and is stable at room temperature for 90 days without requiring refrigeration.

Who is the commercialization partner for JYLAMVO?

EVERSANA is the commercialization partner for JYLAMVO, providing comprehensive launch support including field deployment sales, medical information, and patient services.

What are the key indications for JYLAMVO?

JYLAMVO is indicated for the treatment of acute lymphoblastic leukemia as part of a combination chemotherapy maintenance regimen, among other indications.

How has Shorla Oncology supported the launch of JYLAMVO financially?

Shorla Oncology raised $35 million in Series B funding, which has enabled the company to accelerate the growth of its oncology portfolio, including the commercialization of JYLAMVO.

What is the future outlook for Shorla Oncology's pipeline and financial trajectory?

Shorla Oncology has an advanced pipeline of oncology therapies, with two NDAs under FDA review. This pipeline growth, combined with the commercial success of JYLAMVO, suggests a promising future for both the company's market presence and financial performance.

Sources

1. Shorla Oncology & EVERSANA Announce U.S. Commercial Launch of FDA-Approved JYLAMVO. PR Newswire.
2. Shorla Oncology Announces FDA Filing Acceptance of New Drug Application to Treat Certain Forms of Leukemia and Other Cancers. BioSpace.
3. Methotrexate Injection Market 2024-2031 Porter's Five Forces. OpenPR.
4. Shorla Oncology and Eversana announce US launch of first oral methotrexate solution. BioPharma Reporter.
5. Prescription Drug User Fee Act - FDA. FDA.