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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 are two patents 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-four drug master file entries for this compound. One supplier is listed for this compound. There are three tentative approvals for this compound. Additional details are available on the pemetrexed disodium profile page.

Summary for NDA: 021462

pemetrexed disodium
Formulation / Manufacturing:see details

Pharmacology for NDA: 021462

Suppliers and Packaging for NDA: 021462

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
pemetrexed disodium
INJECTABLE;IV (INFUSION) 021462 NDA Eli Lilly and Company 0002-7623 0002-7623-01 1 VIAL in 1 CARTON (0002-7623-01) > 20 mL in 1 VIAL
pemetrexed disodium
INJECTABLE;IV (INFUSION) 021462 NDA Eli Lilly and Company 0002-7640 0002-7640-01 1 VIAL in 1 CARTON (0002-7640-01) > 4 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)StrengthEQ 500MG BASE/VIAL
Approval Date:Feb 4, 2004TE:RLD:Yes
Patent:5,344,932*PEDPatent Expiration:Jan 24, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:7,772,209*PEDPatent Expiration:May 24, 2022Product Flag?Substance Flag?Delist Request?Y
Regulatory Exclusivity Expiration:Oct 17, 2015

Expired Orange Book Patents for NDA: 021462

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
pemetrexed disodium
INJECTABLE;IV (INFUSION)021462-002Sep 7, 20075,217,974*PED► subscribe
pemetrexed disodium
INJECTABLE;IV (INFUSION)021462-001Feb 4, 20045,217,974*PED► subscribe
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