Last Updated: September 24, 2026

Details for New Drug Application (NDA): 209472

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NDA 209472 describes PEMFEXY, which is a drug marketed by Eagle Pharms and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the PEMFEXY profile page.

The generic ingredient in PEMFEXY is pemetrexed. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the pemetrexed profile page.

Summary for 209472

Tradename:	PEMFEXY
Applicant:	Eagle Pharms
Ingredient:	pemetrexed
Patents:	3

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 209472

Generic Entry Date for 209472^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: 9,604,990 Dosage: SOLUTION;INTRAVENOUS

^*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: 209472

Mechanism of Action	Folic Acid Metabolism Inhibitors

Suppliers and Packaging for NDA: 209472

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PEMFEXY	pemetrexed	SOLUTION;INTRAVENOUS	209472	NDA	Eagle Pharmaceuticals, Inc.	42367-531	42367-531-33	1 VIAL in 1 CARTON (42367-531-33) / 20 mL in 1 VIAL
PEMFEXY	pemetrexed	SOLUTION;INTRAVENOUS	209472	NDA	Acacia Pharma, Ltd.	71390-250	71390-250-02	1 VIAL in 1 CARTON (71390-250-02) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	500MG/20ML (25MG/ML)
Approval Date:	Feb 8, 2020	TE:		RLD:	Yes
Patent:	11,793,813	Patent Expiration:	Feb 19, 2036	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	12,115,164	Patent Expiration:	Feb 19, 2036	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	FOR USE IN THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (NSCLC)
Patent:	12,115,164	Patent Expiration:	Feb 19, 2036	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	FOR USE IN THE TREATMENT OF PATIENTS WITH MALIGNANT PLEURAL MESOTHELIOMA

Expired US Patents for NDA 209472

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eagle Pharms	PEMFEXY	pemetrexed	SOLUTION;INTRAVENOUS	209472-001	Feb 8, 2020	7,772,209	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.