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:	133
Clinical Trials:	8
Patent Applications:	4,404
Formulation / Manufacturing:	see details
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 Generic Entry Opportunity Date for RASUVO

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

See all RASUVO clinical trials

Pharmacology for RASUVO

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

Anatomical Therapeutic Chemical (ATC) Classes for RASUVO

L01BA	Folic acid analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

L04AX	Other immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for RASUVO

RASUVO is protected by one US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting RASUVO

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
Medexus	RASUVO	methotrexate	SOLUTION;SUBCUTANEOUS	205776-007	Jul 10, 2014		RX	Yes	Yes
Medexus	RASUVO	methotrexate	SOLUTION;SUBCUTANEOUS	205776-004	Jul 10, 2014		RX	Yes	Yes
Medexus	RASUVO	methotrexate	SOLUTION;SUBCUTANEOUS	205776-008	Jul 10, 2014		RX	Yes	Yes
Medexus	RASUVO	methotrexate	SOLUTION;SUBCUTANEOUS	205776-002	Jul 10, 2014		RX	Yes	Yes
Medexus	RASUVO	methotrexate	SOLUTION;SUBCUTANEOUS	205776-003	Jul 10, 2014		RX	Yes	Yes
Medexus	RASUVO	methotrexate	SOLUTION;SUBCUTANEOUS	205776-006	Jul 10, 2014		RX	Yes	Yes

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,severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, psoralens and ultraviolet A (PUVA), and retinoids, 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
Ukraine	95488	КОНЦЕНТРИРОВАННЫЙ РАСТВОР МЕТОТРЕКСАТА ДЛЯ ПОДКОЖНОГО ВВЕДЕНИЯ;КОНЦЕНТРОВАНИЙ РОЗЧИН МЕТОТРЕКСАТУ ДЛЯ ПІДШКІРНОГО ВВЕДЕННЯ (CONCENTRATED METHOTREXATE SOLUTION FOR SUBCUTANEOUS INTRODUCTION)
Russian Federation	2009106053	КОНЦЕНТРИРОВАННЫЕ РАСТВОРЫ МЕТОТРЕКСАТА
Croatia	P20110148
Slovenia	2046332
Canada	2659662	SOLUTIONS DE METHOTREXATE CONCENTREES (CONCENTRATED METHOTREXATE SOLUTIONS)
Germany	102006033837	Konzentrierte Methotrexat-Lösungen
South Korea	20090079876	CONCENTRATED METHOTREXATE SOLUTIONS