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. Three 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:	1
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
Virginia Commonwealth University	Phase 1
Pfizer	Phase 1
Vanderbilt 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

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
World Intellectual Property Organization (WIPO)	0009186
Japan	2015042270	危険有害性薬剤の注入システム (HAZARDOUS AGENT INJECTION SYSTEM)
China	102612381	Hazardous agent injection system
South Korea	20070117543	PREFILLED NEEDLE ASSISTED JET INJECTOR

Market Dynamics and Financial Trajectory for OTREXUP PFS

Last updated: February 20, 2026

What Is the Market Position of OTREXUP PFS?

OTREXUP PFS (Methotrexate Injectable Auto-Injector) is indicated for the management of rheumatoid arthritis, psoriasis, and other autoimmune diseases. It offers subcutaneous administration optimized for patient convenience and adherence. Since its launch, OTREXUP has targeted the pharmaceutical segment focusing on self-administration and outpatient treatments.

How Does the Market Size and Growth Potential Look?

Estimates place the global autoimmune disease treatment market at $160 billion in 2022, with a compounded annual growth rate (CAGR) of about 6.5% through 2027.[1] Among these, methotrexate accounts for a significant portion, with about $4 billion in 2022 sales, predominantly in oral form. The injectable segment, including OTREXUP, captures a niche driven by patient preference and physician recommendations for severe cases.

The U.S. autoimmune treatment market is the largest regional segment, valued at approximately $70 billion in 2022, with methotrexate making up roughly 20% of this segment. OTREXUP’s penetration within this market remains under 10%, due to limited awareness and insurance coverage challenges.

How Do Pricing Strategies and Reimbursement Policies Affect Financial Trajectory?

OTREXUP’s retail price is approximately $3,000 per injector, with insurance reimbursements varying by insurer and patient copays. The drug's coverage is influenced by policies that favor oral methotrexate as first-line therapy due to lower costs. Prior authorization requirements and step therapy protocols tend to delay uptake.

Medicare and Medicaid typically reimburse OTREXUP at the average sales price (ASP) plus 6%, but limitations in patient access impact overall sales volume. The manufacturer’s negotiations with pharmacy benefit managers (PBMs) have resulted in tier placements that influence patient out-of-pocket costs.

What Are Key Market Barriers and Opportunities?

Barriers include:

• Prescription inertia: Physicians prefer oral methotrexate, especially during early disease stages.
• Reimbursement hurdles: Insurance policies favor less expensive oral formulations.
• Patient acceptance: Needle aversion impacts adherence and demand.

Opportunities involve:

• Increasing awareness of OTREXUP’s convenience over traditional injections.
• Insurance coverage expansion driven by evidence of improved adherence.
• Entry into emerging markets with rising autoimmune disease prevalence.

How Does Competitive Pressure Shape Financial Outcomes?

OTREXUP competes with:

• Traditional subcutaneous methotrexate injections, which are less costly but less convenient.
• Oral methotrexate, representing the cost leader in treatment options.
• Biosimilars and newer biologic agents, which target more severe or refractory cases.

Market share remains limited due to the dominance of oral methotrexate. However, OTREXUP’s strategic positioning as a patient-friendly alternative supports potential growth through targeted physician education and payor negotiations.

What Is the Financial Outlook for OTREXUP PFS?

In terms of revenue, OTREXUP’s sales in the U.S. peaked around $100 million in 2020 before declining to an estimated $70 million in 2022.[2] Growth projections suggest a slow increase to approximately $120 million by 2025, contingent on:

• Increased insurance coverage.
• Broader clinician adoption.
• Competitive pricing strategies.

The product’s profitability is sensitive to manufacturing costs, marketing expenditure, and rebate obligations. The current patent expiry in 2030 allows continued market exclusivity but invites biosimilar challenges.

Summary Table: Key Metrics for OTREXUP PFS

Metric	2020	2022	2025 (Projected)
U.S. Sales Revenue	~$100 million	~$70 million	~$120 million
Market Share in Injectables	~8%	~9%	~12%
Market Penetration	Limited	Limited	Moderate
Pricing (per injector)	~$3,000	~$3,000	~$3,200 (anticipated)

Key Takeaways

• Market for injectable methotrexate remains niche due to dominance of oral formulations and reimbursement barriers.
• Growth prospects depend on expanding insurance coverage, physician adoption, and patient acceptance.
• Competitive landscape includes traditional injections, biosimilars, and biologics.
• Sales are projected to grow slowly, with revenues reaching $120 million by 2025 under current assumptions.
• Price increases are offset by payer negotiations and competition.

FAQs

1. What factors influence the adoption rate of OTREXUP?
Physician prescribing habits, insurance coverage policies, patient acceptance of injections, and comparative costs against oral methotrexate.

2. How do reimbursement policies impact OTREXUP’s sales?
Reimbursement levels, formulary placement, and prior authorization requirements determine patient access and out-of-pocket costs, affecting overall sales.

3. What is the potential for biosimilar entry?
Biosimilars for methotrexate or similar biologics could erode market share post-patent expiry in 2030, prompting cost competition.

4. How does patient preference influence the market?
Patients favor treatments that minimize administration complexity; OTREXUP’s auto-injector improves convenience but still faces needle aversion.

5. What are the major growth drivers for OTREXUP?
Increased physician awareness, better insurance coverage, and expansion into international markets with rising autoimmune disease prevalence.

References

[1] MarketsandMarkets. (2022). Autoimmune Disease Therapeutics Market. Retrieved from https://www.marketsandmarkets.com/

[2] EvaluatePharma. (2023). Prescription Drug Sales Data. Retrieved from https://www.evaluate.com/