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Last Updated: November 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021462

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NDA 021462 describes ALIMTA, which is a drug marketed by Lilly and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and four Paragraph IV challenges. Additional details are available on the ALIMTA profile page.

The generic ingredient in ALIMTA is pemetrexed disodium. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pemetrexed disodium profile page.
Summary for 021462
Tradename:ALIMTA
Applicant:Lilly
Ingredient:pemetrexed disodium
Patents:1
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 021462
Generic Entry Date for 021462*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTABLE;IV (INFUSION)

*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: 021462
Suppliers and Packaging for NDA: 021462
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462 NDA Eli Lilly and Company 0002-7623 0002-7623-01 1 VIAL in 1 CARTON (0002-7623-01) > 20 mL in 1 VIAL
ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462 NDA Eli Lilly and Company 0002-7640 0002-7640-01 1 VIAL in 1 CARTON (0002-7640-01) > 4 mL in 1 VIAL
Paragraph IV (Patent) Challenges for 021462
Tradename Dosage Ingredient NDA Submissiondate
ALIMTA POWDER;INTRAVENOUS pemetrexed disodium 021462 2016-10-06
ALIMTA POWDER;INTRAVENOUS pemetrexed disodium 021462 2012-06-27
ALIMTA POWDER;INTRAVENOUS pemetrexed disodium 021462 2008-07-01
ALIMTA POWDER;INTRAVENOUS pemetrexed disodium 021462 2008-02-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 500MG BASE/VIAL
Approval Date:Feb 4, 2004TE:RLD:Yes
Patent:  Start TrialPatent Expiration:May 24, 2022Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 100MG BASE/VIAL
Approval Date:Sep 7, 2007TE:RLD:Yes
Patent:  Start TrialPatent Expiration:May 24, 2022Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021462

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-002 Sep 7, 2007   Start Trial   Start Trial
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-001 Feb 4, 2004   Start Trial   Start Trial
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-001 Feb 4, 2004   Start Trial   Start Trial
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-002 Sep 7, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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