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Last Updated: May 19, 2022

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 eleven patents protecting this drug.

This drug has thirty-six patent family members in thirteen 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 Generic Entry Opportunity 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
University of Wisconsin, MadisonPhase 1
Virginia Commonwealth UniversityPhase 1
PfizerPhase 1

See all OTREXUP clinical trials

Pharmacology for OTREXUP

US Patents and Regulatory Information for OTREXUP

OTREXUP is protected by eleven US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of OTREXUP 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 OTREXUP

Injector safety device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Prefilled syringe jet injector
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Hazardous agent injection system
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: SUBCUTANEOUS INJECTION OF METHOTREXATE

Prefilled syringe jet injector
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Hazardous agent injection system
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: SUBCUTANEOUS INJECTION OF METHOTREXATE

Injector safety device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Hazardous agent injection system
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: SUBCUTANEOUS INJECTION OF METHOTREXATE

Hazardous agent injection system
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: SUBCUTANEOUS INJECTION OF METHOTREXATE

Prefilled syringe jet injector
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Prefilled syringe jet injector
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Injector safety device
Patent Number: See Plans and Pricing
Patent Expiration: 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
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-008 Mar 24, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-002 Oct 11, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-006 Mar 24, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-004 Oct 11, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-007 Mar 24, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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

Expired US Patents for OTREXUP

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-003 Oct 11, 2013 See Plans and Pricing See Plans and Pricing
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-008 Mar 24, 2016 See Plans and Pricing See Plans and Pricing
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-005 Nov 7, 2014 See Plans and Pricing See Plans and Pricing
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-004 Oct 11, 2013 See Plans and Pricing See Plans and Pricing
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-003 Oct 11, 2013 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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: See Plans and Pricing

Canada

Patent: 95730
Estimated Expiration: See Plans and Pricing

China

Patent: 1132820
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 50892
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 50892
Estimated Expiration: See Plans and Pricing

Patent: 95009
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 42286
Estimated Expiration: See Plans and Pricing

Israel

Patent: 4765
Estimated Expiration: See Plans and Pricing

Japan

Patent: 16328
Estimated Expiration: See Plans and Pricing

Patent: 08528126
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 50892
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 070117543
Estimated Expiration: See Plans and Pricing

Spain

Patent: 16135
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 OTREXUP around the world.

Country Patent Number Title Estimated Expiration
South Korea 20120028294 HAZARDOUS AGENT INJECTION SYSTEM See Plans and Pricing
South Korea 20070117543 PREFILLED NEEDLE ASSISTED JET INJECTOR See Plans and Pricing
China 1323230 See Plans and Pricing
Japan 2015042270 危険有害性薬剤の注入システム (HAZARDOUS AGENT INJECTION SYSTEM) See Plans and Pricing
Austria 281195 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
AstraZeneca
Merck
Boehringer Ingelheim
McKinsey

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.