Details for New Drug Application (NDA): 204824

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NDA 204824 describes OTREXUP PFS, which is a drug marketed by Otter Pharms and is included in one NDA. It is available from two suppliers. 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. Four suppliers are listed for this compound. Additional details are available on the methotrexate profile page.

Summary for 204824

Tradename:	OTREXUP PFS
Applicant:	Otter Pharms
Ingredient:	methotrexate
Patents:	14

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 204824

Generic Entry Date for 204824^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

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:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	10MG/0.4ML (10MG/0.4ML)
Approval Date:	Oct 11, 2013	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Mar 10, 2029	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Jan 24, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	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
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-002	Oct 11, 2013	⤷ Sign Up	⤷ Sign Up
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-003	Oct 11, 2013	⤷ Sign Up	⤷ Sign Up
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-007	Mar 24, 2016	⤷ Sign Up	⤷ Sign Up
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-002	Oct 11, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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