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Last Updated: November 4, 2024

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 one supplier. There are two patents protecting this drug. Additional details are available on the PEMFEXY profile page.

The generic ingredient in PEMFEXY is pemetrexed. There are twenty-nine drug master file entries for this compound. Two 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:2
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209472
Generic Entry Date for 209472*:
Constraining patent/regulatory exclusivity:
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
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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength500MG/20ML (25MG/ML)
Approval Date:Feb 8, 2020TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Feb 19, 2036Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Oct 28, 2035Product Flag?Substance Flag?YDelist Request?

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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. 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.