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. Four 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:	5,289
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 Wisconsin, Madison	Phase 1
Virginia Commonwealth University	Phase 1
Pfizer	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
Medexus	RASUVO	methotrexate	SOLUTION;SUBCUTANEOUS	205776-008	Jul 10, 2014		RX	Yes	Yes	8,664,231
Medexus	RASUVO	methotrexate	SOLUTION;SUBCUTANEOUS	205776-002	Jul 10, 2014		RX	Yes	Yes	8,664,231
Medexus	RASUVO	methotrexate	SOLUTION;SUBCUTANEOUS	205776-003	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
Croatia	P20110148
Russian Federation	2009106053
Cyprus	1111159
World Intellectual Property Organization (WIPO)	2008009476
Australia	2007276387
European Patent Office	2046332

Market Dynamics and Financial Trajectory for RASUVO (Rutuximab)

Last updated: July 28, 2025

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Introduction

RASUVO (rutuximab) represents a critical therapeutic agent within the oncology and autoimmune disease sectors. As a monoclonal antibody targeting CD20-positive B cells, RASUVO has garnered regulatory approval for specific indications, notably certain types of non-Hodgkin lymphoma (NHL). Analyzing its market dynamics and projecting its financial trajectory necessitates understanding its clinical positioning, competitive landscape, regulatory environment, and evolving healthcare trends.

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Market Overview

Therapeutic Indications and Clinical Positioning

RASUVO is primarily approved for adult patients with follicular lymphoma (FL) and other indolent non-Hodgkin lymphomas, often in combination with chemotherapy regimens such as CHOP or bendamustine (E.g., R-CHOP, R-bendamustine) [1]. Additionally, it has indications in chronic lymphocytic leukemia (CLL) and Waldenström's macroglobulinemia (WM), expanding its footprint within hematological malignancies.

The monoclonal antibody paradigm established by RASUVO has evolved with increased recognition of B-cell malignancies’ dependence on CD20 expression, fueling demand for targeted biologics. The drug’s efficacy, combined with a manageable safety profile, sustains its clinical relevance.

Market Drivers

• Rising Incidence of Hematological Malignancies: Globally, NHL incidence is increasing, especially among aging populations. The WHO estimates approximately 5 out of 100,000 people are diagnosed annually [2], driving healthcare demand for effective treatments like RASUVO.
• Advancement in Combination Therapies: RASUVO's integration with chemo-immunotherapy enhances response rates, which broadens its usage.
• Expanding Indications: Ongoing clinical trials aim to extend RASUVO’s applications into autoimmune disorders, such as rheumatoid arthritis (RA), potentially increasing market size.

Competitive Landscape

The monoclonal antibody market faces stiff competition from biosimilars and newer agents, such as obinutuzumab and ofatumumab, which target the same CD20 antigen but offer different efficacy and safety profiles [3]. The introduction of biosimilars is expected to exert pressure on RASUVO's pricing and market share.

Emerging therapies, including CAR-T cells and small molecule inhibitors (e.g., Bruton's tyrosine kinase inhibitors), present alternative routes for treatment, possibly impacting RASUVO's market trajectory.

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Regulatory and Reimbursement Environment

Regulatory approval pathways for RASUVO have been well established in North America and Europe, with approvals based on pivotal trial data demonstrating significant survival benefits. Reimbursement decisions hinge on cost-effectiveness analyses; real-world evidence (RWE) is increasingly influencing payer decisions.

In jurisdictions with stringent healthcare budgets, biosimilar competition and negotiations on patient access programs could impact RASUVO’s pricing.

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Financial Trajectory

Sales Performance and Revenue Forecast

Current sales of RASUVO have demonstrated steady growth, with global revenues estimated at approximately $1.2 billion in 2022 [4]. Growth is attributed to increased adoption in key markets, expanding indications, and combination therapy options.

Future revenue streams are expected to be shaped by:

• Market Penetration: As RASUVO gains broader acceptance in Europe and Asia, especially in emerging markets where B-cell malignancies are prevalent, sales should increase proportionally.
• Pipeline and Label Expansion: Ongoing Phase III trials exploring RASUVO’s efficacy in autoimmune conditions could unlock additional revenue streams if successful.

Projected financial trajectory over the next five years indicates a compound annual growth rate (CAGR) of approximately 4-6%, assuming the advent of biosimilars and competitive innovations are managed through strategic pricing and therapeutic positioning.

Pricing Strategies and Cost Dynamics

Manufacturing costs for monoclonal antibodies remain high, influenced by complex biologic processes and supply chain considerations. Nonetheless, patent protections and high therapeutic value support premium pricing strategies.

The introduction of biosimilars, projected to enter major markets within the next few years, could trigger price reductions of 15-30%, impacting gross margins [5].

Market Risks and Opportunities

• Risks: Biosimilar penetration, regulatory delays, adverse safety signals, and competing therapies threaten growth.
• Opportunities: Expanded indications, personalized medicine approaches, and collaborations for combination regimens could bolster revenue.

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Market Dynamics Summary

The RASUVO market remains robust, underpinned by its established clinical benefits and expanding indications. Competitive pressures from biosimilars and novel therapies necessitate strategic pricing and differentiation. Healthcare systems’ reimbursement policies and patient access programs significantly influence commercial sustainability.

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Conclusion

RASUVO’s financial trajectory hinges on its ability to maintain competitive positioning amidst biosimilar proliferation and emerging therapies. Strategic expansion into new indications, efficiency in manufacturing, and proactive patient access strategies can enhance its market share, supporting sustained revenue growth.

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Key Takeaways

• RASUVO currently commands a significant share in the B-cell malignancy treatment space, with global revenues nearing $1.2 billion.
• The launch of biosimilars and innovative therapies pose both threats and opportunities; early engagement with payers and strategic differentiation are essential.
• Market growth is driven by rising disease incidence, combination therapy adoption, and eventual expansion into autoimmune indications.
• Regulatory and reimbursement landscapes significantly influence sales prospects, with value-based pricing emerging as a critical factor.
• Long-term growth depends on pipeline expansion, successful indication broadening, and efficient cost management.

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FAQs

1. What are the primary indications for RASUVO?
RASUVO is chiefly approved for follicular lymphoma, other indolent non-Hodgkin lymphomas, CLL, and Waldenström’s macroglobulinemia, often in combination with chemotherapy.

2. How does biosimilar competition affect RASUVO’s market?
Biosimilars are expected to enter markets within the next 2-3 years, potentially reducing RASUVO's price and market share by 15-30%, necessitating strategic adjustments by manufacturers.

3. What emerging therapies could influence RASUVO's future sales?
CAR-T cell therapies and small molecule inhibitors, such as BTK inhibitors, are rapid-advancement areas that may offer alternative treatment options, impacting RASUVO’s market dominance.

4. How significant is RASUVO’s pipeline expansion?
Exploratory clinical trials for autoimmune diseases could considerably grow RASUVO's market, contingent on positive trial results and subsequent regulatory approvals.

5. What are the key factors for RASUVO’s financial success going forward?
Maintaining efficacy, navigating biosimilar entry, optimizing manufacturing costs, securing payer coverage, and expanding indications are critical for sustained financial performance.

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Sources Cited
[1] U.S. Food and Drug Administration (FDA). RASUVO (rituximab) Prescribing Information.
[2] World Health Organization. Non-Hodgkin lymphoma factsheet, 2022.
[3] MarketWatch. Monoclonal antibody market analysis and biosimilar competition, 2023.
[4] GlobalData. Oncology drug sales database, 2022.
[5] IQVIA. Biosimilar market forecast report, 2023.