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
Vanderbilt University	Phase 1
University of Virginia	Phase 1
University of Wisconsin, Madison	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

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
European Patent Office	4427737
World Intellectual Property Organization (WIPO)	2009114542
South Korea	101597672

OTREXUP PFS Market Analysis and Financial Projection

Last updated: April 24, 2026

OTREXUP PFS: Market Dynamics and Financial Trajectory

OTREXUP PFS (generic name: methotrexate injection; brand “OTREXUP”) sells as a single-use, prefilled, needle-capable methotrexate autoinjector/pen platform in the US and is positioned in a mature, label-narrow segment of methotrexate treatments used across rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA), and psoriasis indications. Financial trajectory and market dynamics are driven by (1) methotrexate’s long-standing position as a core DMARD, (2) competitive substitution between oral and injectable methotrexate formats, (3) formulary placement and payer rebate structures, (4) biosimilar-like brand switching is not the mechanism here, but “device-to-device” and “formulation-to-formulation” switching is, and (5) patent and exclusivity status that determines how long OTREXUP PFS protected premium pricing versus immediate generic replacement risk.

What is OTREXUP PFS and what market segment does it address?

OTREXUP PFS is a prefilled injection product for methotrexate. It competes within the injectable methotrexate category against other methotrexate presentations (including prefilled syringes and vials where available through channels) and against oral methotrexate for patients and prescribers willing to shift route. In practice, its value proposition is adherence, ease of use, and reduced administration complexity versus vials, which supports payer acceptance in patients where injection is preferred and where switching away from a needle product is not clinically favored.

Core market drivers

• Chronic use and long patient lifetime: RA and psoriasis are long-duration therapies; stable demand exists when patients remain on an injectable route.
• Clinical interchangeability within methotrexate: Formularies may allow interchange among methotrexate forms with step edits, prior authorization, or quantity controls.
• Adherence and administration burden: Device-based brands maintain pricing power where payer and provider workflows standardize on specific injection devices.

How do market dynamics typically work for OTREXUP PFS buyers (payers, providers, patients)?

Payer dynamics

• Coverage decisions usually hinge on net price after rebates and administrative simplicity (preferred products, dosing flexibility, and patient support program alignment).
• A brand like OTREXUP PFS wins where payers can achieve “preferred injectable” status by pricing below clinically comparable options or by using patient support economics.

Provider dynamics

• Rheumatology and dermatology clinics often standardize injection workflows (training, storage, stocking, and nurse administration protocols).
• Once a practice forms an “injection habit” with a device platform, switching costs push retention.

Patient dynamics

• Patients with needle preference, prior injection experience, or barriers to oral dosing are more likely to stay on an injector device.
• Device usability changes discontinuation patterns; discontinuation increases if device availability and support programs degrade.

Net effect on competitive behavior

• Brand-to-brand switching is less frequent than in biologics, but format switching is common when payers steer toward a lower-cost injectable or oral option.
• The market behaves like a competitive generic drug ecosystem with an attached device preference premium rather than like patent-protected small molecules for long periods beyond exclusivity windows.

What is the financial trajectory and what would be expected over time?

Without product-specific financial statements, the most defensible financial trajectory framework for OTREXUP PFS is based on how methotrexate injection brands evolve in the US:

1. Launch/early scale-up period: Growth driven by new prescriber adoption, starter volumes, and early payer contracting.
2. Peak protected period: Revenue stabilizes when formulary positioning locks in preferred status for a subset of plans.
3. Late-stage maturity and substitution pressure: As exclusivity ends, generic or lower-cost competitors compress price; volume typically shifts to lower-cost presentations.
4. Post-substitution period: Revenue declines, sometimes with partial retention if device preference remains strong in certain patient cohorts or if payers face contracting inertia.

Expected inflection points

• Exclusivity expiration or entry of authorized generics: Drives net price compression and volume erosion.
• Formulary redesigns: Annual or semi-annual payer updates can cause sharp channel swings.
• Supply stability: Any supply disruption in injectable methotrexate formats can temporarily raise share for available competitors, and then reverse when back in stock.

Revenue trajectory profile (typical pattern)

• Up/plateau during protected positioning
• Down after loss of premium pricing and increased substitution
• Choppy decline if payer contracts and patient support temporarily delay migration to the cheapest option

What are the strongest economic levers affecting OTREXUP PFS performance?

1) Net pricing versus list price

Injectable specialty-like dynamics occur even when the drug is “small molecule.” The key is the rebate and access structure:

• Preferred formulary status can keep rebates manageable and net price higher.
• Losing “preferred” status can cut net revenue quickly even before generic entry because formulary coverage drives utilization.

2) Coverage and utilization management

The most direct economic control mechanisms are:

• Step edits (trial of preferred methotrexate formulations)
• Prior authorization thresholds
• Quantity limits tied to dosing schedules
• Patient support carve-outs that reduce friction for adherence

3) Device and logistics economics

Device products can command premium gross margin while:

• Manufacturing yield and device QC remain stable
• Distribution is consistent
• Replacement costs and support programs do not erode margins

But they also face:

• Higher cost-of-goods than vial/vial-admin pathways
• Potential reimbursement differences for device-specific SKUs

4) Competitive formats

Key substitution risks come from:

• Lower-cost injectable methotrexate formats
• Oral methotrexate covered at lower cost
• Any competitor device that reduces the “training advantage” of OTREXUP PFS

How does the US regulatory and exclusivity landscape shape the market?

OTREXUP PFS is a branded methotrexate injection device product. US market entry and exclusivity are shaped by:

• Orange Book listing (application type, patent number, and expiration)
• 180-day exclusivity mechanics for generic entrants where applicable
• Patent litigation outcomes that affect timing of generic launches
• Regulatory review timelines that can delay or accelerate entry after exclusivity expiry

In a typical scenario for established branded injectables, once relevant Orange Book protection expires or is cleared, the market shifts toward lower-cost substitutions.

What does the competitive map look like in practical terms?

OTREXUP PFS competes on three axes:

1. Injection convenience (device usability, administration workflow)
2. Payer access (preferred status, net pricing, rebate corridor)
3. Treatment continuity (patient retention after switching)

Where OTREXUP PFS holds share

• Patients already using the device
• Practices that standardize injection workflows
• Plans where the brand maintains preferred injectable status

Where it loses share

• Plans that steer to lower net-cost methotrexate formats
• Patients initiated on an alternative injectable or oral therapy
• Post-exclusivity environments where net price compression accelerates

What KPIs should investors and business leaders track for OTREXUP PFS trajectory?

Use these to validate whether revenue is in protected plateau or substitution compression:

KPI	What to measure	What it signals
Net price trend	Average realized net price by quarter	Preferred status vs formulary loss
Prescription volume trend	Scripts and patient starts	Patient onboarding vs migration
Mix shift	Injectable device vs oral, and within injectable competitors	Substitution direction
Coverage footprint	# of covered lives / formulary tier status	Access strength or erosion
Manufacturer supply & stability	Backorders and allocation events	Temporary share swings and delayed patient starts
Patient support outcomes	Enrollment rates, adherence metrics	Device retention power

Actionable investment and R&D implications

Investment stance

• Model revenue as a function of (a) retention in covered preferred segments, and (b) generic substitution timing and pace.
• In the absence of a robust biologics-like differentiation, OTREXUP PFS behaves like a brand with a device-maintained premium that erodes as payer incentives shift.

R&D stance

• Protect the “device moat” via usability, training materials, and supply reliability.
• If extending life-cycle, prioritize combination packaging, dosing convenience, and platform reliability. In a substitution-heavy small-molecule market, operational advantage often matters more than incremental clinical claims.

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Key Takeaways

• OTREXUP PFS sits in a mature methotrexate injection market where revenue is driven by formulary access and device-led retention more than by breakthrough differentiation.
• Market dynamics are dominated by payer rebate structures, coverage tiering, and substitution between methotrexate formats (injectable to injectable and oral).
• Financial trajectory follows a typical protected-brand-to-substitution compression profile: plateau under preferred access, then net price compression and volume erosion after relevant exclusivity/patent barriers fall.
• The most actionable way to track trajectory is via net price, volume, mix shift, coverage footprint, and supply stability.

FAQs

1) Is OTREXUP PFS a biologic or a small-molecule injection?
It is a methotrexate injection product, so it is a small-molecule therapy, not a biologic.

2) What most strongly influences OTREXUP PFS revenue: price or volume?
Both matter, but payer net pricing and preferred formulary placement typically determine how quickly revenue compresses when substitution pressure rises.

3) Does OTREXUP PFS face biosimilar-style competition?
No. Competition is primarily from other methotrexate formulations and generic substitution dynamics tied to exclusivity and patent status.

4) Why does device usability matter economically for OTREXUP PFS?
Device usability improves adherence and reduces switching friction, which can sustain retention and delay migration within covered patient cohorts.

5) What are the main timing drivers for revenue changes?
Exclusivity or patent resolution (entry of lower-cost competitors), payer formulary refresh cycles, and supply stability.

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References

[1] FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/ (Accessed 2026-04-24).