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Last Updated: February 26, 2024

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. Three 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 three 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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Drug patent expirations by year for OTREXUP
Drug Prices for OTREXUP

See drug prices for OTREXUP

Drug Sales Revenue Trends for OTREXUP

See drug sales revenues for OTREXUP

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OTREXUP
Generic Entry Date for OTREXUP*:
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 OTREXUP

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Virginia Commonwealth UniversityPhase 1
PfizerPhase 1
Vanderbilt UniversityPhase 1

See all OTREXUP clinical trials

Pharmacology for OTREXUP

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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Prefilled syringe injector
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Prefilled syringe jet injector
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Hazardous agent injection system
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: SUBCUTANEOUS INJECTION OF METHOTREXATE

Prefilled syringe jet injector
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Hazardous agent injection system
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: SUBCUTANEOUS INJECTION OF METHOTREXATE

Injector safety device
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Hazardous agent injection system
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: SUBCUTANEOUS INJECTION OF METHOTREXATE

Hazardous agent injection system
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: SUBCUTANEOUS INJECTION OF METHOTREXATE

Prefilled syringe jet injector
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Prefilled syringe jet injector
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Injector safety device
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-004 Oct 11, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-006 Mar 24, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-006 Mar 24, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 204824-007 Mar 24, 2016 ⤷  Try a Trial ⤷  Try a Trial
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-008 Mar 24, 2016 ⤷  Try a Trial ⤷  Try a Trial
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-004 Oct 11, 2013 ⤷  Try a Trial ⤷  Try a Trial
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-005 Nov 7, 2014 ⤷  Try a Trial ⤷  Try a Trial
>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
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 95730
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1132820
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 50892
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 50892
Estimated Expiration: ⤷  Try a Trial

Patent: 95009
Estimated Expiration: ⤷  Try a Trial

Finland

Patent: 50892
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 42286
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 4765
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 16328
Estimated Expiration: ⤷  Try a Trial

Patent: 08528126
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 50892
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 070117543
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 16135
Estimated Expiration: ⤷  Try a Trial

Patent: 08027
Estimated Expiration: ⤷  Try a Trial

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
China 102612381 Hazardous agent injection system ⤷  Try a Trial
Australia 5470499 ⤷  Try a Trial
Japan 2015042270 危険有害性薬剤の注入システム (HAZARDOUS AGENT INJECTION SYSTEM) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2009114542 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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