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
Summary for OTREXUP
International Patents: | 36 |
US Patents: | 11 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 130 |
Clinical Trials: | 7 |
Patent Applications: | 4,393 |
Formulation / Manufacturing: | see details |
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 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
Sponsor | Phase |
---|---|
University of Wisconsin, Madison | Phase 1 |
Virginia Commonwealth University | Phase 1 |
Pfizer | Phase 1 |
Pharmacology for OTREXUP
Drug Class | Folate Analog Metabolic Inhibitor |
Mechanism of Action | Folic Acid Metabolism Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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 |