OTREXUP Drug Patent Profile
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Which patents cover Otrexup, and when can generic versions of Otrexup launch?
Otrexup is a drug marketed by Otter Pharms and is included in one NDA. There are fourteen patents protecting this drug.
This drug has thirty-seven patent family members in fourteen countries.
The generic ingredient in OTREXUP 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 Otrexup
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 24, 2026. This may change due to patent challenges or generic licensing.
There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
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Summary for OTREXUP
| International Patents: | 37 |
| US Patents: | 14 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 137 |
| Clinical Trials: | 7 |
| Patent Applications: | 4,357 |
| Drug Prices: | Drug price information for OTREXUP |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OTREXUP |
| What excipients (inactive ingredients) are in OTREXUP? | OTREXUP excipients list |
| DailyMed Link: | OTREXUP at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OTREXUP
*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 OTREXUP
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Virginia Commonwealth University | Phase 1 |
| Pfizer | Phase 1 |
| Vanderbilt University | Phase 1 |
Pharmacology for OTREXUP
| Drug Class | Folate Analog Metabolic Inhibitor |
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
US Patents and Regulatory Information for OTREXUP
OTREXUP is protected by fourteen US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of OTREXUP is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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 OTREXUP
Injector safety device
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Prefilled syringe injector
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Prefilled syringe jet injector
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Hazardous agent injection system
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: SUBCUTANEOUS INJECTION OF METHOTREXATE
Prefilled syringe jet injector
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Hazardous agent injection system
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: SUBCUTANEOUS INJECTION OF METHOTREXATE
Injector safety device
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Hazardous agent injection system
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: SUBCUTANEOUS INJECTION OF METHOTREXATE
Hazardous agent injection system
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: SUBCUTANEOUS INJECTION OF METHOTREXATE
Prefilled syringe jet injector
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Prefilled syringe jet injector
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Injector safety device
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-003 | Oct 11, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-004 | Oct 11, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-006 | Mar 24, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-006 | Mar 24, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-008 | Mar 24, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Otter Pharms | OTREXUP PFS | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-010 | May 31, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for OTREXUP
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-002 | Oct 11, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-002 | Oct 11, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-002 | Oct 11, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-003 | Oct 11, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-004 | Oct 11, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Otter Pharms | OTREXUP | methotrexate | SOLUTION;SUBCUTANEOUS | 204824-002 | Oct 11, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for OTREXUP
| 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 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for OTREXUP
When does loss-of-exclusivity occur for OTREXUP?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Brazil
Patent: 0614025
Patent: injetores de jato
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 95730
Patent: INJECTEUR A SERINGUE PREREMPLIE ASSISTE D'UNE AIGUILLE (PREFILLED NEEDLE ASSISTED JET INJECTOR)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1132820
Patent: Prefilled needle assisted jet injector
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 50892
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 50892
Patent: INJECTEUR A SERINGUE PREREMPLIE ASSISTE D'UNE AIGUILLE (PREFILLED NEEDLE ASSISTED SYRINGE JET INJECTOR)
Estimated Expiration: ⤷ Sign Up
Patent: 95009
Patent: INJECTEUR À JET DE SERINGUE PRÉREMPLIE (PREFILLED SYRINGE JET INJECTOR)
Estimated Expiration: ⤷ Sign Up
Finland
Patent: 50892
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 42286
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 4765
Patent: PREFILLED NEEDLE ASSISTED JET INJECTOR
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 16328
Estimated Expiration: ⤷ Sign Up
Patent: 08528126
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 50892
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 070117543
Patent: PREFILLED NEEDLE ASSISTED JET INJECTOR
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 16135
Estimated Expiration: ⤷ Sign Up
Patent: 08027
Estimated Expiration: ⤷ Sign Up
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 OTREXUP around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Finland | 1850892 | ⤷ Sign Up | |
| Japan | 2002522171 | ⤷ Sign Up | |
| European Patent Office | 1850892 | INJECTEUR A SERINGUE PREREMPLIE ASSISTE D'UNE AIGUILLE (PREFILLED NEEDLE ASSISTED SYRINGE JET INJECTOR) | ⤷ Sign Up |
| Israel | 184765 | PREFILLED NEEDLE ASSISTED JET INJECTOR | ⤷ Sign Up |
| China | 102612381 | Hazardous agent injection system | ⤷ Sign Up |
| Japan | 2008528126 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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