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-four patent family members in nineteen 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:	24
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	137
Patent Applications:	2,972
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/003983Nordimet 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/003756In 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
Lithuania	3212237
Japan	2023103402
Japan	2021138748
Japan	2017533274

Market Dynamics and Financial Trajectory for JYLAMVO

Last updated: July 27, 2025

Introduction

JYLAMVO emerges within the competitive landscape of innovative therapeutics, positioned to address significant unmet medical needs. As a novel pharmaceutical agent, understanding its market dynamics and anticipated financial trajectory is critical for stakeholders, from investors to healthcare providers. This analysis synthesizes current market data, regulatory pathways, competitive landscape, and economic projections to illuminate JYLAMVO’s potential impact and commercial viability.

Overview of JYLAMVO

JYLAMVO represents a new class of therapeutics designed to target [specify therapeutic area, e.g., autoimmune disorders, oncology, rare diseases], with indications extending from [specific conditions]. Developed by [developer’s name], its mechanism of action involves [brief description of biological pathway or innovation], aiming to [describe therapeutic benefit or improvement over existing treatments].

The drug has recently attained [phase of clinical trials], with preliminary data indicating [efficacy, safety profile, or other key findings]. The FDA’s or EMA’s potential designation as [breakthrough therapy, orphan drug, etc.] reflects its perceived therapeutic promise.

Market Dynamics

Global Market Size and Growth Trends

The target market for JYLAMVO is projected to experience Compound Annual Growth Rate (CAGR) of [e.g., 8-12%], reaching an estimated $[value] billion by [year, e.g., 2030]. Factors fueling growth include increasing disease prevalence, advancements in personalized medicine, and rising healthcare expenditure.

For example, if JYLAMVO targets a rare disease, the orphan drug market offers a lucrative opportunity. The global orphan drug market alone is expected to reach $[value] billion by 2025, with an CAGR faster than the broader pharmaceutical sector due to incentives and unmet needs [1].

Regulatory and Reimbursement Environment

Rapid regulatory approval pathways like breakthrough therapy designation or orphan drug status can significantly shorten the time to market, enhancing the drug’s financial prospects. Reimbursement policies, especially within developed markets like the U.S. and EU, heavily influence adoption rates. Payer willingness to reimburse at premium prices hinges on demonstrated cost-effectiveness and compelling clinical data.

Competitive Landscape

JYLAMVO’s entrance will encounter competition from existing therapies, biosimilars, or upcoming pipeline drugs. Its differentiation depends on:

• Superior efficacy or safety profile
• Reduced dosing frequency
• Lower cost or ease of administration
• Personalized treatment options

Current market leaders in the therapeutic area include [list major competitors], with combined revenues exceeding $[figure] billion annually. JYLAMVO’s ability to carve a niche depends on its clinical advantages and strategic market positioning.

Supply Chain and Manufacturing Considerations

Early-stage supply chain robustness and manufacturing scalability play vital roles. Strategic partnerships with contract manufacturing organizations (CMOs) can mitigate risks of delays and quality issues, directly impacting financial forecasts.

Financial Trajectory

Revenue Projections

Projected revenues for JYLAMVO depend on approval timelines, pricing strategies, and market penetration. Assuming successful phase III results by [year] and regulatory approval shortly thereafter, initial sales could be:

• Year 1: $[value] million to $[value] million, primarily from early adopters and existing clinical trial participants.
• Year 2-3: Accelerated growth driven by broader physician adoption, expected to reach $[value] billion in global sales by [year].

Pricing assumptions must align with the drug’s therapeutic advantage and market standards. Premium pricing of $[amount] per dose or per treatment cycle is typical for novel therapies in niche markets.

Profitability and Cost Considerations

Cost of goods sold (COGS), R&D expenditure, and commercialization costs shape profitability timelines. High manufacturing costs, especially for biologics or complex small molecules, may delay profitability, emphasizing the importance of efficient production.

Gross margins are projected at [percentage], with operating expenses comprising clinical development, marketing, regulatory compliance, and administrative overhead. Breakeven could occur within [number] of years post-launch, contingent upon sales volume and cost management.

Investment and Funding Outlook

Initial investments in clinical development may total $[amount], with subsequent funding rounds aimed at commercialization efforts. Strategic collaborations with pharmaceutical partners could unlock additional capital and market access, impacting the financial trajectory positively.

Market Risks and Uncertainties

Key risks include:

• Clinical trial failures or delays
• Regulatory approval hurdles
• Competitive pressures
• Pricing and reimbursement challenges
• Intellectual property disputes

Mitigating these risks involves early engagement with regulators, robust trial designs, and strong patent protections.

Market Adoption and Commercial Strategy

To achieve projected revenues, JYLAMVO’s commercialization plan should focus on:

• Targeted physician education
• Demonstrating real-world effectiveness
• Strategic pricing models
• Timely market entry in high-value jurisdictions
• Building collaborations with healthcare systems and payers

Leveraging digital health and direct-to-consumer channels can further accelerate adoption.

Key Drivers of Financial Success

• Regulatory designations expediting approval
• Strong clinical data establishing efficacy
• Effective pricing strategies aligned with therapeutic value
• Early and sustained payer engagement
• Strategic production capacity scaling

Conclusion

JYLAMVO’s market potential hinges on navigating complex regulatory pathways, establishing a differentiated therapeutic profile, and securing stakeholder confidence. If upcoming clinical trial results remain positive, and strategic commercialization execution aligns with market conditions, JYLAMVO can expect a promising financial trajectory within its therapeutic niche.

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Key Takeaways

• Regulatory and market incentives such as breakthrough status can accelerate JYLAMVO’s time to revenue.
• Differentiation from existing therapies is critical for gaining market share; clarity of clinical advantage must underpin pricing.
• Market size and growth potential are robust in niche therapeutic areas, particularly for orphan indications.
• Cost management and supply chain efficiency are vital for maintaining margins and achieving profitability.
• Stakeholder engagement, including payers and providers, will influence adoption speed and revenue realization.

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FAQs

1. When is JYLAMVO expected to reach the market?
If current Phase III trial timelines proceed as planned, regulatory approval could occur within [approximate timeframe, e.g., 1–2 years] following positive trial results, targeting a market launch around [year].

2. What are the main competitive advantages of JYLAMVO?
Its benefits include [list advantages such as improved efficacy, safety profile, dosing convenience, or tailored therapy], setting it apart from existing treatments.

3. How does pricing influence JYLAMVO’s market success?
Premium pricing is justified by demonstrable clinical benefits, but must balance payer willingness to reimburse to ensure market penetration and revenues.

4. What are the primary risks associated with JYLAMVO’s commercialization?
Key risks include clinical failure, regulatory delays, reimbursement limitations, and aggressive competition, all of which could impact financial outcomes.

5. How does the orphan drug designation impact JYLAMVO’s financial prospects?
It provides benefits such as market exclusivity, tax incentives, and grant support, which enhance profitability and incentivize early investment.

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Sources:
[1] Global Orphan Drug Market Analysis, MarketWatch, 2022.