RASUVO Drug Patent Profile

Which patents cover Rasuvo, and when can generic versions of Rasuvo launch?

Rasuvo is a drug marketed by Medexus and is included in one NDA. There is one patent protecting this drug.

This drug has twenty-nine patent family members in twenty-one countries.

The generic ingredient in RASUVO 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 Rasuvo

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 1, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for RASUVO

International Patents:	29
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	100
Clinical Trials:	8
Patent Applications:	5,022
Drug Prices:	Drug price information for RASUVO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RASUVO
What excipients (inactive ingredients) are in RASUVO?	RASUVO excipients list
DailyMed Link:	RASUVO at DailyMed

See drug prices for RASUVO

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

Constraining patent/regulatory exclusivity:

8,664,231

NDA:

205776

Dosage:

SOLUTION;SUBCUTANEOUS

^*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.

Recent Clinical Trials for RASUVO

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 RASUVO clinical trials

Pharmacology for RASUVO

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

US Patents and Regulatory Information for RASUVO

RASUVO is protected by one US patents.

This potential generic entry date is based on patent 8,664,231.

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
Medexus	RASUVO	methotrexate	SOLUTION;SUBCUTANEOUS	205776-001	Jul 10, 2014		RX	Yes	Yes	8,664,231
Medexus	RASUVO	methotrexate	SOLUTION;SUBCUTANEOUS	205776-007	Jul 10, 2014		RX	Yes	Yes	8,664,231
Medexus	RASUVO	methotrexate	SOLUTION;SUBCUTANEOUS	205776-004	Jul 10, 2014		RX	Yes	Yes	8,664,231

EU/EMA Drug Approvals for RASUVO

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 RASUVO

When does loss-of-exclusivity occur for RASUVO?

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

Australia

Austria

Brazil

Canada

Croatia

Cyprus

Denmark

European Patent Office

Germany

Japan

Mexico

Montenegro

Poland

Portugal

Russian Federation

Serbia

Slovenia

South Korea

Spain

Ukraine

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 RASUVO around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	14872
Austria	E491455
Australia	2007276387

RASUVO (methotrexate) Market Dynamics and Financial Trajectory: Pricing, Uptake, Competition, and Patent-Led Risk

Last updated: June 10, 2026

RASUVO, a subcutaneous methotrexate autoinjector, sits in the chronic rheumatology market (rheumatoid arthritis and related uses). Its financial trajectory is shaped by (1) persistent methotrexate price pressure and generic substitution in the broader methotrexate ecosystem, (2) the uptake ceiling for patients who require injectable dosing, (3) competitive pressure from alternative methotrexate injection products and pen/auto-injector formats, and (4) time-based erosion of exclusivity tied to formulation and device IP rather than core methotrexate.

Because RASUVO’s revenue is closely tied to branded positioning in an otherwise commoditized methotrexate category, its “financial trajectory” is best modeled as a branded-injection revenue curve: high penetration during launch years, followed by steady share dilution as formulary access expands for lower-cost competitors and as payers steer toward preferred injectable methotrexate options.

What is RASUVO and which market segments drive demand?

RASUVO is a methotrexate (MTX) product delivered by subcutaneous administration for chronic inflammatory conditions. In practice, demand is driven by the subset of patients who do not achieve adequate control with oral methotrexate, who have gastrointestinal intolerance, or who receive injectable therapy due to dosing consistency and tolerability.

Where does RASUVO sit in the methotrexate landscape?

Methotrexate is an old, widely available drug, so RASUVO’s commercial advantage is not the active ingredient; it is the branded delivery system that reduces administration friction (ease-of-use, dosing confidence, and patient training).

Key commercial implication: RASUVO competes on device experience, payer preference, and channel relationships, not on new clinical endpoints.

Which payer behaviors shape uptake?

The dominant levers are:

• Formulary placement for subcutaneous MTX products.
• Prior authorization policies that may require step therapy from oral MTX.
• Site-of-care and nurse-admin workflow in specialty pharmacy and clinic settings.
• Copay and patient assistance programs that influence adherence during ramp-up.

How do pricing and cost controls affect RASUVO revenue?

RASUVO’s revenue trajectory depends on how quickly payers move from branded injectable MTX to lower-cost alternatives. In older drug classes, cost controls often progress in phases: initial coverage with restrictions, then broader preferred access for competitively priced injection formats.

What are the typical price pressure channels?

1. PBM and formulary steering: Preferential contracting with generic or lower-cost injectables compresses net price.
2. Dose and schedule economics: MTX is dosed weekly; payer math rewards products that minimize administrative overhead and dispensing friction.
3. Switching costs: Device switches can be sticky early but erode as competing devices become familiar and as training materials standardize.

What does “net price” likely do after generic in-class competition?

While RASUVO is still a branded product, its net revenue is vulnerable to:

• Increased plan-level discounts tied to volume thresholds.
• Step edits that narrow access.
• Substitution at the pharmacy counter for equivalent strengths when switching is allowed.

When does RASUVO face major exclusivity loss and patent expiration risk?

RASUVO’s exclusivity story is best understood as a multi-layer IP stack: device/formulation claims, method-of-use claims (if present), and any line-extension patents tied to dosing presentations. In generic-drug markets, the strongest revenue threats occur when Orange Book-listed patents expire or are effectively cleared through settlement or litigation outcomes.

What is the practical “expiration-driven” timeline?

For methotrexate delivery products, the key question is whether the Orange Book patents tied to RASUVO’s specific injectable format have already expired, are nearing expiration, or remain asserted. Revenue erosion typically begins:

• at the point of Paragraph IV filings (credible generic threat),
• and accelerates after sustained entry by authorized generics or court-confirmed readiness.

Because this analysis requires patent-by-patent Orange Book dates and litigation outcomes, a full and accurate timeline cannot be produced from the information provided here.

What generic entry risks exist for RASUVO?

Generic entry risk for RASUVO hinges on whether ANDA filers can design around:

• the autoinjector/device-specific claims,
• the formulation claims (buffering, concentration, excipients),
• and the dosing regimen claims (if any method-of-use protections exist).

In practice, the risk is highest when patents covering the delivery system and formulation are weak or have expired, enabling “same patient, same route, lower price” substitution.

How do device and formulation patents affect generic design-around?

• If a device claim is broad, an ANDA may use a different injection mechanism but still deliver MTX subcutaneously in a similar way.
• If formulation claims are narrow, entrants can match bioequivalence while changing excipients within allowed ranges.

Generic entrants often target the lowest-cost path: a manufacturable container system that supports BE and a labeling strategy that avoids method-of-use constraints.

Which companies compete with RASUVO in subcutaneous methotrexate?

RASUVO competes with:

• alternative branded or authorized injectable methotrexate products,
• lower-cost generic subcutaneous MTX products (where available),
• and pharmacy-administration alternatives (some practices mix oral-to-injectable sequencing depending on patient tolerance).

Competitive dynamic: share depends on “coverage + training”

Even if clinical equivalence is accepted, uptake depends on:

• whether payers list the product without restrictive PA,
• whether the clinic workflow supports the device,
• and whether patient education programs exist to reduce early discontinuations.

What FDA regulatory status matters for RASUVO’s market trajectory?

FDA status affects:

• listing on the Orange Book,
• eligibility for generic ANDA approvals,
• and any switching restrictions based on labeling and bioequivalence determinations.

Why is the Orange Book list critical?

The Orange Book determines the “real” exclusivity floor for generic entry. The market typically reprices the branded product’s future revenue when:

• patents are listed and appear enforceable,
• patents expire,
• or patents are removed/invalidated via settlement or court rulings.

A complete and accurate RASUVO regulatory-and-patent status mapping requires Orange Book data by patent and expiration date that is not provided here.

How strong is the patent estate for RASUVO?

Patent strength for branded injection products is measured by:

• number of Orange Book-listed patents,
• remaining life per patent family,
• and whether device, formulation, or method claims can block ANDA approval.

For RASUVO specifically, a patent strength assessment requires enumerating the asserted/Orange Book patents and their expiration dates by jurisdiction, plus any litigation posture.

A full estate scoring model cannot be constructed without those inputs.

What patent litigation affects RASUVO and generic timelines?

Patent litigation impacts both:

• probability and timing of generic entry,
• and the expectation of settlement-driven “at-risk entry” reductions.

A litigation review requires docket outcomes, settlement terms, and court decisions by case. No case list or litigation timeline is available in the provided material, so a complete legal impact analysis cannot be produced.

What formulations and dose strengths shape RASUVO demand?

RASUVO’s market penetration is influenced by:

• availability across commonly used MTX dose strengths,
• ease of titration for weekly dosing adjustments,
• and patient usability.

Why dose coverage matters commercially

In chronic dosing therapies, gaps in available strengths increase the likelihood of:

• off-label adjustments,
• switching to alternative injectable MTX products,
• or reverting to oral dosing when injectable coverage is denied.

How does RASUVO compare with other methotrexate injections on commercial levers?

Compared with generic MTX injections, RASUVO’s relative strengths tend to be:

• device experience (automation of steps),
• consistent dosing delivery,
• and branded patient support infrastructure.

Relative weaknesses tend to be:

• premium pricing versus generics,
• payer restrictions or step edits,
• and vulnerability once substitute injectable options become preferred.

A rigorous comparison requires net price, formulary status, and realized market share for specific competitor SKUs, which are not supplied here.

Revenue exposure: what proportion of branded injection MTX economics is RASUVO?

RASUVO’s revenue exposure is concentrated in:

• US outpatient rheumatology and specialty pharmacy channels,
• and the small-but-persistent injectable MTX patient pool.

In MTX therapy, shifts between oral and subcutaneous routes can move patient share between products. These shifts are influenced by:

• tolerability,
• therapeutic persistence,
• insurance coverage,
• and patient switching behavior.

Quantifying RASUVO’s revenue exposure requires company-level sales history and segment reporting data.

Key Takeaways

• RASUVO competes in a commoditized methotrexate category, so financial trajectory is driven by branded device positioning, payer access, and substitution dynamics, not by clinical novelty of methotrexate.
• Net price compression is the core risk vector as payers prefer lower-cost subcutaneous MTX options over time.
• The decisive determinants of longer-term revenue are Orange Book patent life and any Paragraph IV or litigation outcomes tied to RASUVO’s injectable format.
• Accurate exclusivity loss, generic entry probability, and patent estate strength require patent-by-patent Orange Book enumeration and litigation docket data, which are not present in the provided information.

FAQs

1. How do payers decide coverage for subcutaneous methotrexate autoinjectors like RASUVO?
2. What drives patient switching from RASUVO to other injectable methotrexate products?
3. How does Orange Book patent listing affect the timing of generic ANDA approvals for RASUVO?
4. What factors increase or decrease RASUVO persistence in rheumatoid arthritis patients?
5. Which competitive levers matter most for branded MTX injectables: net price, PA criteria, or device usability?

DrugChatter Q&A for RASUVO

Is Rasuvo an auto-injector?
Is rasuvo an autoinjector?
Does rasuvo cause nausea like oral methotrexate?
How is rasuvo different from oral methotrexate?