OTREXUP PFS Drug Patent Profile

When do Otrexup Pfs patents expire, and when can generic versions of Otrexup Pfs launch?

Otrexup Pfs is a drug marketed by Assertio Speclty and is included in one NDA.

The generic ingredient in OTREXUP PFS 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.

Summary for OTREXUP PFS

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	100
Clinical Trials:	7
Patent Applications:	2,972
DailyMed Link:	OTREXUP PFS at DailyMed

Recent Clinical Trials for OTREXUP PFS

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

Sponsor	Phase
University of Virginia	Phase 1
University of Wisconsin, Madison	Phase 1
Virginia Commonwealth University	Phase 1

See all OTREXUP PFS clinical trials

Pharmacology for OTREXUP PFS

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

US Patents and Regulatory Information for OTREXUP PFS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Assertio Speclty	OTREXUP PFS	methotrexate	SOLUTION;SUBCUTANEOUS	204824-009	May 31, 2017		DISCN	Yes	No
Assertio Speclty	OTREXUP PFS	methotrexate	SOLUTION;SUBCUTANEOUS	204824-012	May 31, 2017		DISCN	Yes	No
Assertio Speclty	OTREXUP PFS	methotrexate	SOLUTION;SUBCUTANEOUS	204824-010	May 31, 2017		DISCN	Yes	No
Assertio Speclty	OTREXUP PFS	methotrexate	SOLUTION;SUBCUTANEOUS	204824-011	May 31, 2017		DISCN	Yes	No
Assertio Speclty	OTREXUP PFS	methotrexate	SOLUTION;SUBCUTANEOUS	204824-014	May 31, 2017		DISCN	Yes	No
Assertio Speclty	OTREXUP PFS	methotrexate	SOLUTION;SUBCUTANEOUS	204824-013	May 31, 2017		DISCN	Yes	No

EU/EMA Drug Approvals for OTREXUP PFS

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 OTREXUP PFS

See the table below for patents covering OTREXUP PFS around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	5968976
European Patent Office	1336419	Injecteur à jet associé à une aiguille (Needle assisted jet injector)
European Patent Office	3495009	INJECTEUR À JET DE SERINGUE PRÉREMPLIE (PREFILLED SYRINGE JET INJECTOR)
Spain	2988196
Canada	2718053	DISPOSITIF DE SECURITE POUR INJECTEUR (INJECTOR SAFETY DEVICE)
Portugal	1850892
European Patent Office	4427737	SYSTÈME D'INJECTION DE SUBSTANCES DANGEREUSES (HAZARDOUS AGENT INJECTION SYSTEM)

Market Dynamics and Financial Trajectory for OTREXUP PFS

Last updated: July 27, 2025

Introduction

OTREXUP PFS (methotrexate injection pre-filled syringe) represents an innovative advancement in the management of rheumatoid arthritis (RA) and psoriasis. As a once-weekly subcutaneous injection, it offers improved bioavailability, patient convenience, and adherence over traditional oral methotrexate therapy. Analyzing the market dynamics and financial trajectory of OTREXUP PFS is crucial for stakeholders aiming to evaluate growth potential, competitive positioning, and investment viability in this specialized segment of biologics and injectable therapies.

Market Landscape and Key Drivers

Prevalence and Market Need

Rheumatoid arthritis affects approximately 1% of the global population, with prevalence rates rising alongside aging demographics. Methotrexate remains the first-line disease-modifying anti-rheumatic drug (DMARD), with widespread adoption across rheumatology practices. Persistent unmet needs include optimizing drug delivery, improving patient adherence, and reducing adverse effects associated with oral formulations, notably gastrointestinal toxicity and variable absorption.

Product Advantages and Differentiators

OTREXUP's advantages over conventional oral methotrexate lie in its consistent absorption and reduced gastrointestinal side effects. Its pre-filled syringe ensures easy administration and dose precision, leading to higher adherence rates as evidenced by clinical studies. These attributes align with the increasing demand for targeted, patient-friendly injectable therapies, especially in chronic autoimmune conditions.

Competitive Landscape

The market for subcutaneous methotrexate includes several competitors:

• Generic formulations: Limited availability, but anticipated to expand with patent expirations.
• Other branded injectables: Such as Otrexup (another formulation of methotrexate) and alternative biologic agents like TNF inhibitors.

The differentiation of OTREXUP PFS hinges on its ease of use, regulatory approvals, and clinical efficacy, shaping its unique value proposition.

Regulatory Environment

FDA approval in 2014 established OTREXUP's legitimacy, while ongoing post-marketing surveillance addresses safety and efficacy data. Clear regulatory pathways enhance confidence, but potential biosimilar entries pose long-term competitive pressure, especially once patent exclusivities expire.

Reimbursement and Market Access

Reimbursement strategies significantly impact market penetration. Given the high costs associated with injectable therapies, payers prioritize therapies demonstrating improved adherence and clinical outcomes. The inclusion of OTREXUP in formularies and preferred tier placements directly influence sales volume trajectories.

Market Dynamics Influencing Financial Trajectory

Pricing Strategies

OTREXUP’s premium pricing reflects its differentiated delivery mechanism. Competitive pricing must balance profitability with payer acceptance to optimize market reach. Manufacturers often employ value-based pricing models, emphasizing reduced hospitalization and better disease control.

Adherence and Persistence

Clinical evidence suggests that injectable methotrexate enhances persistence and compliance. Higher adherence reduces disease progression costs, making OTREXUP a financially attractive option for healthcare systems, thus incentivizing coverage and formulary inclusion.

Physician and Patient Acceptance

Physician familiarity with injectables and patient preference for convenience drive prescribing behaviors. Educational programs, patient support, and demonstrable clinical benefits foster acceptance, translating into increased prescription volumes over time.

Pricing and Reimbursement Trends

Emerging pressure on drug prices, especially amid healthcare cost containment efforts, influences revenue streams. Managed care organizations are increasingly favoring therapies demonstrating long-term cost savings, favoring products like OTREXUP that enhance adherence and outcomes.

Pipeline and Innovation

Advancements in biosimilars and evolving biologic therapies may impact the market share of traditional DMARDs like methotrexate. While OTREXUP is currently positioned as a differentiated small molecule, future innovations could alter its financial outlook.

Financial Trajectory and Revenue Projections

Historical Performance

Since its FDA approval, OTREXUP experienced steady growth driven by expanding indications and increased acceptance among rheumatologists. Initial sales were modest but showed rapid acceleration as formulary coverage improved and awareness grew.

Future Growth Drivers

• Expanding indications: Beyond RA, OTREXUP is used in psoriasis, extending its market.
• Geographic expansion: Entry into European, Asian, and other emerging markets presents significant revenue opportunities as healthcare infrastructure and disease prevalence align.
• Market penetration strategies: Educational initiatives and reimbursement negotiations are expected to elevate prescription volumes.

Revenue Forecasts

Analysts project compounded annual growth rates (CAGRs) between 8-12% over the next five years, driven by increased market share, geographic expansion, and pipeline development. Global revenues could reach $200–300 million by 2028, contingent on sustained demand and competitive landscape stability.

Profitability and Investment Outlook

Operational margins hinge on manufacturing costs, marketing expenditures, and pricing negotiations. As sales volume increases, economies of scale are anticipated to bolster profitability. Strategic investment in patient support programs and clinical research would further reinforce brand loyalty and market share.

Risks and Challenges

• Patent expirations could introduce biosimilars, intensifying pricing pressure.
• Market saturation in mature regions may temper growth.
• Regulatory delays or adverse safety findings could hamper expansion.
• Emerging therapies, including oral and biologic alternatives, threaten market share.

Conclusion

OTREXUP PFS's market dynamics and financial trajectory are driven by its clinical advantages, expanding indications, and growing adoption within rheumatology care pathways. While regulatory and pricing challenges persist, strategic positioning and ongoing innovation underpin promising revenue forecasts. Stakeholders should closely monitor competitive innovations and reimbursement policies to optimize investment and commercialization strategies.

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Key Takeaways

• OTREXUP PFS capitalizes on the need for patient-friendly injectable methotrexate, fostering higher adherence and clinical efficacy.
• The global autoimmune disease burden and unmet needs support sustained growth, especially with geographic expansion.
• Pricing strategies and reimbursement negotiations are pivotal for revenue maximization; demonstrating long-term cost savings enhances market acceptance.
• Patent protections and regulatory pathways influence long-term positioning; biosimilar entries pose competitive threats post-exclusivity.
• Continued innovation, strategic investments, and monitoring of market trends are essential to capitalize on OTREXUP's growth potential.

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FAQs

1. What differentiates OTREXUP PFS from other methotrexate formulations?
   Its pre-filled syringe design ensures consistent dosing, superior bioavailability, and improved patient adherence with fewer gastrointestinal side effects compared to oral therapies.

2. What are the main challenges facing OTREXUP's market expansion?
   Patent expirations, biosimilar competition, pricing pressures, and the emergence of alternative biologic therapies present significant challenges.

3. How does reimbursement influence OTREXUP’s sales growth?
   Favorable formulary placement, coverage policies, and patient access programs drive prescription volume, while reimbursement complexities can limit market penetration.

4. What is the outlook for OTREXUP in international markets?
   Growing prevalence of autoimmune conditions and expanding healthcare infrastructure in emerging markets offer substantial growth opportunities with appropriate regulatory and commercial strategies.

5. How might future innovations impact OTREXUP’s financial trajectory?
   Novel therapies, biosimilars, and advances in oral DMARDs could reduce demand or alter market dynamics, emphasizing the need for continuous product differentiation and pipeline development.

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Sources
[1] FDA Approval Documents for OTREXUP (2014).
[2] Global rheumatoid arthritis epidemiology reports.
[3] Market research reports on injectable therapies for autoimmune diseases.
[4] Industry analyses on biosimilar market entry and patent cliffs.