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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 204824

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NDA 204824 describes OTREXUP PFS, which is a drug marketed by Assertio Speclty and is included in one NDA. It is available from one supplier. Additional details are available on the OTREXUP PFS profile page.

The generic ingredient in OTREXUP PFS 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.

Summary for 204824

Tradename:	OTREXUP PFS
Applicant:	Assertio Speclty
Ingredient:	methotrexate
Patents:	15

Pharmacology for NDA: 204824

Mechanism of Action	Folic Acid Metabolism Inhibitors

Medical Subject Heading (MeSH) Categories for 204824

Abortifacient Agents, Nonsteroidal
Antimetabolites, Antineoplastic
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Nucleic Acid Synthesis Inhibitors

Suppliers and Packaging for NDA: 204824

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824	NDA	Antares Pharma, Inc.	54436-010	54436-010-01	1 SYRINGE in 1 CARTON (54436-010-01) / .4 mL in 1 SYRINGE
OTREXUP PFS	methotrexate	SOLUTION;SUBCUTANEOUS	204824	NDA	Antares Pharma, Inc.	54436-010	54436-010-01	1 SYRINGE in 1 CARTON (54436-010-01) / .4 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	10MG/0.4ML (10MG/0.4ML)
Approval Date:	Oct 11, 2013	TE:		RLD:	Yes
Patent:	⤷ Start Trial	Patent Expiration:	Mar 10, 2029	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Start Trial	Patent Expiration:	Jan 24, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Start Trial	Patent Expiration:	Mar 19, 2030	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 204824

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-007	Mar 24, 2016	⤷ Start Trial	⤷ Start Trial
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-003	Oct 11, 2013	⤷ Start Trial	⤷ Start Trial
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-006	Mar 24, 2016	⤷ Start Trial	⤷ Start Trial
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-001	Oct 11, 2013	⤷ Start Trial	⤷ Start Trial
Assertio Speclty	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-007	Mar 24, 2016	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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