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
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 |


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
Sponsor | Phase |
---|---|
Vanderbilt University | Phase 1 |
University of Virginia | Phase 1 |
University of Wisconsin, Madison | Phase 1 |
Pharmacology for RASUVO
Drug Class | Folate Analog Metabolic Inhibitor |
Mechanism of Action | Folic Acid Metabolism Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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 |