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:	137
Clinical Trials:	8
Patent Applications:	4,417
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

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/003983 Nordimet 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/003756 In 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
European Patent Office	2046332	SOLUTIONS DE MÉTHOTREXATE CONCENTRÉES (CONCENTRATED METHOTREXATE SOLUTIONS)
Denmark	2046332
Japan	2009544636
Germany	502007005972
Mexico	2009000812	SOLUCIONES DE METOTREXATO CONCENTRADAS. (CONCENTRATED METHOTREXATE SOLUTIONS.)

RASUVO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rasuvo

Overview of Rasuvo

Rasuvo, a formulation of methotrexate, is a key product in Medexus Pharmaceuticals' portfolio, primarily used to treat rheumatoid arthritis and other autoimmune diseases. Here’s a detailed look at its market dynamics and financial trajectory.

Market Position

Rasuvo has maintained a strong market position in the US branded methotrexate market. As of the trailing 12-month period ended December 31, 2023, and March 31, 2024, Rasuvo held an estimated greater than 80% unit share in this market[1][4].

Unit Demand and Sales Performance

Despite the competitive landscape, Rasuvo has seen robust unit demand. In the trailing 12-month period ended December 31, 2023, and March 31, 2024, unit demand for Rasuvo remained strong, benefiting from its steady supply compared to ongoing shortages of competing products[1][4].

However, the unit demand in the US has faced some challenges. For instance, in the trailing 12-month period ended March 31, 2024, unit demand for Rasuvo in the US decreased by 6% due to lower observed average quantities consumed by newer patients and the greater availability of extended half-life products competing with Rasuvo[4].

Pricing Strategies and Revenue Impact

Medexus has implemented unit-level pricing strategies to defend Rasuvo's strong market position. While these strategies have helped maintain unit demand, they have also led to a reduction in product-level revenue. The company has observed an increasing share of product-level revenue attributable to government-sponsored programs, which benefit from statutory discounts and rebates. This shift has adversely affected total product-level revenue[1][4].

Competitive Landscape

The US branded methotrexate market continues to be competitive, with Rasuvo facing challenges from generic competition and other market dynamics. Despite these challenges, Rasuvo's unique formulation and its autoinjector design have helped it maintain an exclusive or advantaged status with many top payers and pharmacy benefit managers (PBMs)[3].

Impact of Regulatory Changes

The Inflation Reduction Act of 2022 is expected to have an incrementally adverse effect on Rasuvo's product-level revenue due to additional statutory discounts and rebates. This regulatory change is anticipated to continue affecting the product's financial performance in the coming periods[1][4].

Financial Performance

In terms of financial performance, Rasuvo has been a significant contributor to Medexus's revenue. However, the revenue from Rasuvo has been impacted by the factors mentioned above. For example, in the fiscal Q4 2024, the revenue decrease was partly attributed to trends affecting Rasuvo, including lower than expected purchases by pharmacy and wholesale customers and the accumulating effect of unit-level price reductions[4].

Operational Highlights

Medexus continues to focus on defending Rasuvo's strong formulary status. The company's efficient allocation of sales force resources has been crucial in maintaining its market leading position. Despite the challenges, Rasuvo remains a cornerstone of Medexus's commercial activities, and the company is committed to optimizing its commercial opportunities for this product[1][3].

Future Outlook

Looking ahead, Medexus expects the current market dynamics to persist, which may continue to affect Rasuvo's revenue. However, the company's strategic focus on maintaining strong formulary status and optimizing commercial opportunities is expected to help mitigate some of these challenges. The anticipated impact of additional statutory discounts and rebates will need to be carefully managed to ensure the product's continued financial viability[1][4].

Key Takeaways

• Strong Market Position: Rasuvo holds a dominant position in the US branded methotrexate market.
• Unit Demand: Despite some declines, Rasuvo's unit demand remains strong, aided by its steady supply.
• Pricing Strategies: Unit-level pricing strategies have helped maintain demand but reduced revenue.
• Competitive Landscape: Faces competition from generics and extended half-life products.
• Regulatory Impact: Additional statutory discounts and rebates will adversely affect revenue.
• Financial Performance: Significant revenue contributor, but impacted by market trends and regulatory changes.

FAQs

Q: What is Rasuvo used for? A: Rasuvo is used to treat rheumatoid arthritis and other autoimmune diseases.

Q: What is Rasuvo's market share in the US branded methotrexate market? A: Rasuvo holds an estimated greater than 80% unit share in the US branded methotrexate market.

Q: How has unit demand for Rasuvo been affected in recent periods? A: Unit demand for Rasuvo has seen some declines, particularly a 6% decrease in the trailing 12-month period ended March 31, 2024, due to various market factors.

Q: What are the key challenges facing Rasuvo's revenue? A: The key challenges include lower observed average quantities consumed by newer patients, greater availability of competing extended half-life products, and the impact of additional statutory discounts and rebates.

Q: How is Medexus managing the competitive landscape for Rasuvo? A: Medexus is focusing on defending Rasuvo's strong formulary status and optimizing its commercial opportunities through efficient sales force resource allocation and unit-level pricing strategies.

Sources

1. Medexus Announces Fiscal Q3 2024 Results - BioSpace
2. Medexus Pharmaceuticals Reports Financial and Operational Results for the Three- and Six-Month Periods Ending September 30, 2021 - Medexus
3. TSX: MDP | OTCQX: MEDXF - Medexus Presentation Q1 2024 - Medexus
4. Medexus Generates Record Revenue of US$113.1 Million in Fiscal 2024 - Medexus