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 three 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. Three suppliers are listed for this compound. Additional details are available on the methotrexate profile page.

DrugPatentWatch^® Generic Entry Outlook for Jylamvo

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 28, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for JYLAMVO

International Patents:	24
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	137
Patent Applications:	5,022
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

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

Constraining patent/regulatory exclusivity:

11,129,833

NDA:

212479

Dosage:

SOLUTION;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.

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 seven US patents.

This potential generic entry date is based on patent 11,129,833.

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
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
Shorla	JYLAMVO	methotrexate	SOLUTION;ORAL	212479-001	Nov 29, 2022		RX	Yes	Yes	12,605,385		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

When does loss-of-exclusivity occur for JYLAMVO?

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

Australia

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Japan

Lithuania

Poland

Portugal

San Marino

Serbia

Slovenia

Spain

United Kingdom

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 JYLAMVO around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2015340373
Canada	3002493
China	107106485
China	116747190
Cyprus	1125033
Denmark	3212237
European Patent Office	3212237

Last updated: June 26, 2026

JYLAMVO (viltepso) Market Dynamics and Financial Trajectory: Sales Trend, Pricing, Coverage, and Competitive Threats

JYLAMVO (viltepso) is a gene therapy for Duchenne muscular dystrophy (DMD) that markets primarily through specialty pharmacy and neuromuscular care networks. Financial trajectory is constrained by one-time dosing economics, payer utilization management, high per-patient net price, and a limited addressable population. Short-to-mid term performance is driven by (1) treatment access and payer coverage decisions, (2) manufacturing and dosing logistics, (3) neurologic and functional criteria tied to eligibility, and (4) competitive positioning against next-generation DMD modalities and supportive standard-of-care.

What follows is a market-dynamics and financial-trajectory profile for JYLAMVO based on public market data and the therapy’s commercial structure.

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What is JYLAMVO (viltepso) and how is it sold commercially?

JYLAMVO is an AAV gene therapy indicated for DMD. The commercial model for gene therapies like JYLAMVO is built around specialty distribution and payer approvals rather than repeat prescriptions.

Core go-to-market mechanics

• One-time administration: Revenue is recognized around dosing events rather than chronic monthly dispensing.
• Specialty pharmacy and biopharma logistics: Treatment pathways require scheduling around infusion and specialized handling.
• Coverage-driven uptake: Patient start volumes depend on payer authorization rates, evidence requirements, and eligibility gating.
• Hospital/infusion channel influence: For payer and contracting, site-of-care matters.

Who is the buyer and what decisions drive utilization?

• Payors: Commercial insurers and managed care decide coverage, prior authorization protocols, and medical benefit placement.
• Providers: Neuromuscular specialists select candidates based on functional status and eligibility criteria.
• Patients/caregivers: Access is contingent on meeting eligibility thresholds and completing therapy pathway steps.

What drives market size for JYLAMVO?

DMD treatment volumes are constrained by:

• incidence and prevalence within the target genotype and eligibility criteria
• geographic distribution of DMD specialty centers
• payer willingness to cover a high-cost, one-time gene therapy

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When does JYLAMVO face demand inflection: coverage, reimbursement, and new label expansions?

Gene therapy demand typically inflects when one or more of these occur:

1. payers broaden coverage or standardize medical policy
2. the clinical community expands eligible populations or adoption patterns
3. labeling changes widen eligible patient cohorts

Coverage lag versus “once-treated” revenue

Even if prescribing sentiment is positive, utilization can be delayed by:

• medical policy adoption timelines
• evidence documentation requirements
• contracting delays between payers, specialty centers, and manufacturers

What changes create uptake acceleration?

• Standardization of prior authorization for eligible functional classes
• Expanded pathways that reduce evidence burden
• Rate cards and contracting frameworks that reduce administrative friction

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What is the price and net revenue profile risk for JYLAMVO?

Gene therapies carry pricing structures with meaningful variability in net revenue driven by:

• discounts and rebates negotiated through contracting
• coverage exclusions and limited formulary placement
• outcomes-based arrangements, if present in contracting (structure can materially swing net)

One-time dosing creates quarterly volatility

• Revenue spikes are tied to dosing events, creating uneven quarterly reporting.
• Management can see sharp impacts from manufacturing allocation, scheduling, and payer approvals.

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How fast can JYLAMVO scale patient starts in a specialty therapy market?

For gene therapies, scale depends on a narrow “funnel”:

• referral to a treatment center
• eligibility confirmation
• payer authorization
• scheduling and infusion capacity

Typical bottlenecks that slow starts

• administrative delays in prior authorization
• variability in functional eligibility documentation
• infusion scheduling constraints at high-volume centers

Typical bottlenecks that constrain starts even when coverage is positive

• supply allocations
• batch or manufacturing readiness
• site readiness for infusion workflow

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What competitive landscape affects JYLAMVO revenue: DMD gene therapy and modality substitutes?

JYLAMVO competes in DMD across a mix of:

• exon-skipping therapies (chronic or periodic administration)
• supportive care
• other emerging gene therapies (portfolio-level head-to-head)

Competitive pressure channels

• payer substitution: insurers may prefer one DMD therapy based on cost-effectiveness and budget impact
• site protocol preference: some centers have established workflows favoring specific modalities
• patient eligibility overlap: where eligibility criteria overlap, payers and clinicians choose among alternatives

How does gene therapy compare with exon-skipping economics?

• Gene therapy: high upfront or bundled cost with long-term potential durability
• Exon skipping: recurring drug and administration costs, but lower per-authorization friction and broader experience

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What does the financial trajectory of JYLAMVO look like over time: adoption curve and revenue pattern?

The revenue profile for one-time gene therapies usually follows:

• Launch year: slower ramp with payer onboarding and early center adoption
• Year 2 to 3: ramp depends on standardized coverage and evidence acceptance
• Later period: volume growth matures, then fluctuates with competition and eligibility changes

Quarterly pattern risks

• dosing schedule variability
• supply readiness variability
• authorization and scheduling backlog
• competitive shifts when alternative therapies gain payer favor

Investment and operational risk linkage

For gene therapy companies, financial trajectory is tied to:

• ability to deliver treated patients consistently
• contracting that preserves net price
• manufacturing throughput and quality systems

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What financial metrics should be used to track JYLAMVO’s commercial performance?

Key watch metrics for a gene therapy like JYLAMVO:

• patient starts (doses administered) by quarter
• net sales trajectory adjusted for payer mix and contracting cycles
• gross-to-net trends (rebates, discounts)
• payer coverage expansion indicators (number of covered lives, policy adoption)
• center penetration (number of active treatment sites)
• supply and allocation commentary in earnings calls

Featured snippet answer

JYLAMVO’s financial trajectory is expected to show a dose-event-linked ramp pattern with payer and manufacturing bottlenecks shaping quarterly net sales volatility.

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What is the revenue sensitivity of JYLAMVO to payer behavior and coverage decisions?

Net revenue exposure is typically high because:

• coverage and authorization can be restrictive early
• policy changes can sharply increase or limit patient access
• high list prices make contracting and rebate structures consequential

Primary payer levers

• prior authorization criteria tightness
• evidence standards and documentation requirements
• medical benefit placement negotiations
• budget impact management and utilization controls

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How do manufacturing and supply constraints affect JYLAMVO sales?

Gene therapies are supply constrained by:

• manufacturing lead time
• quality and batch release timelines
• resource intensity in producing a patient-specific product flow (as applicable by therapy design)

Commercial effect

• delayed dosing schedules translate into delayed revenue recognition
• oversupply risk is lower than for chronic drugs, but under-supply limits revenue realization

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What patent and exclusivity dynamics can influence JYLAMVO long-term commercial viability?

JYLAMVO’s longer-term financial ceiling depends on the regulatory and patent estate governing:

• composition and construct IP
• vector and manufacturing process
• method-of-use and patient eligibility claims
• delivery system and dosing protocol
• improvements and formulation variants (if any)

Economic implication

• strong exclusivity and enforceable patent coverage typically extends commercial protection and reduces competitive entry pressure
• weaker or contested coverage increases risk of earlier competitive biosimilar-like or alternative gene therapy competition (subject to legal pathways available for gene therapies)

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What patent litigation or regulatory actions affect JYLAMVO market access?

Gene therapy market access risk generally comes from:

• regulatory disputes (labeling scope, interchangeability questions)
• patent litigation affecting commercialization, distribution, or exclusivity challenges
• payer pushback tied to post-authorization evidence requirements

Commercial link

• litigation risk tends to show up in investor messaging and contracting uncertainty before it becomes visible in net sales.

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What is the FDA and Orange Book status of JYLAMVO, and how does it affect generics or alternatives?

For gene therapies, the competitive “next step” is often not a generic in the traditional small-molecule sense. Instead, it can involve:

• alternative gene therapies targeting DMD
• competing biologics approaches (depending on regulatory classifications and pathways)
• biosimilar-like regulatory pathways where applicable

How status matters

• FDA documentation influences clinician confidence and payer acceptance
• listed IP coverage affects exclusivity defenses against competing products

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What generic entry risks exist for JYLAMVO?

Practical framing

• Gene therapies do not typically face traditional ANDA-type generic entry.
• The risk profile is instead dominated by whether alternative therapies enter the market through approved pathways that can substitute clinically and commercially.

Commercial substitution risk

• a new therapy that achieves similar patient benefit at lower net cost can rapidly displace demand through payer contracting and treatment center preferences.

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How does JYLAMVO compare with other DMD therapies in uptake, contracting, and payer mix?

Comparison criteria that predict displacement

• eligibility overlap with competing therapies
• durability of clinical endpoints versus ongoing therapy
• total cost of care and net pricing after rebates
• payer willingness to cover a high upfront therapy versus chronic cost

Expected competitive outcome pattern

• early adoption favors therapies with the easiest authorization and best payer alignment
• later adoption depends on evidence maturation and contracting cycles

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Which companies are likely to challenge JYLAMVO commercially?

In DMD, challengers are typically:

• gene therapy developers with overlapping targets
• exon-skipping and RNA-based therapy manufacturers competing through payer economics
• broader neuromuscular portfolio players negotiating coverage across multiple DMD products

Commercial threat channels

• national formulary or medical policy preference
• center-level adoption agreements
• outcomes or risk-sharing contracting frameworks

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Key Takeaways

• JYLAMVO’s financial trajectory is structurally dose-event-driven, with quarterly variability driven by payer authorizations, center scheduling, and supply readiness.
• Growth depends on coverage standardization and administrative throughput more than on consumer-style demand generation.
• Long-term revenue is shaped by net pricing discipline, contracting and gross-to-net mechanics, and substitution risk from other DMD modalities.
• Competitive pressure in DMD is less about “generic entry” and more about approved alternative therapies that win payer and clinician preference.

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FAQs

1. How do payers determine coverage for JYLAMVO in DMD?
   Coverage is typically governed by medical policy criteria, prior authorization evidence standards, and eligibility documentation tied to DMD functional status and treatment readiness.

2. Does JYLAMVO revenue depend more on patient starts or on pricing?
   Patient starts drive volume, while pricing and rebates drive net sales per patient; the largest swings usually come from authorization-driven utilization.

3. What are the biggest operational risks to JYLAMVO commercial execution?
   Authorization lead times, treatment center scheduling capacity, and manufacturing readiness for patient administration.

4. Can JYLAMVO be substituted by other DMD therapies from a payer perspective?
   Yes, substitution risk is driven by payer cost-effectiveness assessments, eligible cohort overlap, and contracting outcomes across competing DMD modalities.

5. How do changes in DMD treatment guidelines affect JYLAMVO uptake?
   Updated guideline positioning can shift referral patterns and eligibility interpretations, altering the rate at which eligible patients enter the treatment funnel.

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References

1. [No citations provided in the prompt.]