OTREXUP Drug Patent Profile

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

See drug prices for OTREXUP

See drug sales revenues for OTREXUP

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for OTREXUP

NDA:

204824

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

See all OTREXUP clinical trials

Pharmacology for OTREXUP

Drug Class	Folate Analog Metabolic Inhibitor
Mechanism of Action	Folic Acid Metabolism Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for OTREXUP

L01BA	Folic acid analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

L04AX	Other immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for OTREXUP

OTREXUP is protected by eleven US patents.

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

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			Y
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-002	Oct 11, 2013		RX	Yes	Yes			Y
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-006	Mar 24, 2016		RX	Yes	Yes			Y
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-004	Oct 11, 2013		RX	Yes	Yes			Y
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-007	Mar 24, 2016		RX	Yes	Yes			Y

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
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-008	Mar 24, 2016
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-005	Nov 7, 2014
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-004	Oct 11, 2013
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-003	Oct 11, 2013

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

Canada

China

Denmark

European Patent Office

Hungary

Israel

Japan

Portugal

South Korea

Spain

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
South Korea	20070117543	PREFILLED NEEDLE ASSISTED JET INJECTOR
China	1323230
Japan	2015042270	危険有害性薬剤の注入システム (HAZARDOUS AGENT INJECTION SYSTEM)
Austria	281195