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Last Updated: August 8, 2022

RASUVO Drug Patent Profile


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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

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Drug patent expirations by year for RASUVO
Drug Prices for RASUVO

See drug prices for RASUVO

DrugPatentWatch® Estimated Generic Entry Opportunity Date for RASUVO
Generic Entry Date for RASUVO*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Vanderbilt UniversityPhase 1
University of VirginiaPhase 1
University of Wisconsin, MadisonPhase 1

See all RASUVO clinical trials

Pharmacology for RASUVO

US Patents and Regulatory Information for RASUVO

RASUVO is protected by one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of RASUVO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Concentrated methotrexate solutions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: SUBCUTANEOUS INJECTION OF METHOTREXATE

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Medexus RASUVO methotrexate SOLUTION;SUBCUTANEOUS 205776-007 Jul 10, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Medexus RASUVO methotrexate SOLUTION;SUBCUTANEOUS 205776-004 Jul 10, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Medexus RASUVO methotrexate SOLUTION;SUBCUTANEOUS 205776-008 Jul 10, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Medexus RASUVO methotrexate SOLUTION;SUBCUTANEOUS 205776-002 Jul 10, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Medexus RASUVO methotrexate SOLUTION;SUBCUTANEOUS 205776-003 Jul 10, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Medexus RASUVO methotrexate SOLUTION;SUBCUTANEOUS 205776-006 Jul 10, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

Patent: 07276387
Estimated Expiration: See Plans and Pricing

Austria

Patent: 872
Estimated Expiration: See Plans and Pricing

Patent: 1455
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0715433
Estimated Expiration: See Plans and Pricing

Canada

Patent: 59662
Estimated Expiration: See Plans and Pricing

Patent: 69671
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0110148
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 11159
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 46332
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 46332
Estimated Expiration: See Plans and Pricing

Patent: 92235
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2006033837
Estimated Expiration: See Plans and Pricing

Patent: 2007019703
Estimated Expiration: See Plans and Pricing

Patent: 2007005972
Estimated Expiration: See Plans and Pricing

Japan

Patent: 83810
Estimated Expiration: See Plans and Pricing

Patent: 09544636
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 09000812
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 940
Estimated Expiration: See Plans and Pricing

Poland

Patent: 46332
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 46332
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 03044
Estimated Expiration: See Plans and Pricing

Patent: 09106053
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 688
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 46332
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1260554
Estimated Expiration: See Plans and Pricing

Patent: 090079876
Estimated Expiration: See Plans and Pricing

Spain

Patent: 55399
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 488
Estimated Expiration: See Plans and Pricing

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) See Plans and Pricing
Russian Federation 2009106053 КОНЦЕНТРИРОВАННЫЕ РАСТВОРЫ МЕТОТРЕКСАТА See Plans and Pricing
Croatia P20110148 See Plans and Pricing
Slovenia 2046332 See Plans and Pricing
Canada 2659662 SOLUTIONS DE METHOTREXATE CONCENTREES (CONCENTRATED METHOTREXATE SOLUTIONS) See Plans and Pricing
Germany 102006033837 Konzentrierte Methotrexat-Lösungen See Plans and Pricing
South Korea 20090079876 CONCENTRATED METHOTREXATE SOLUTIONS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
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Baxter
Dow
McKinsey
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.