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Last Updated: May 27, 2022

ALIMTA Drug Patent Profile


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When do Alimta patents expire, and when can generic versions of Alimta launch?

Alimta is a drug marketed by Lilly and is included in one NDA. There is one patent protecting this drug and four Paragraph IV challenges.

This drug has eighteen patent family members in eleven countries.

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.

DrugPatentWatch® Generic Entry Outlook for Alimta

Alimta was eligible for patent challenges on February 4, 2008.

There have been fourteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for ALIMTA
Drug Prices for ALIMTA

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Recent Clinical Trials for ALIMTA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The Second Hospital of Hebei Medical UniversityPhase 1
Guangdong 999 Brain HospitalPhase 1
The Affiliated Hospital of Guangdong Medical CollegePhase 1

See all ALIMTA clinical trials

Paragraph IV (Patent) Challenges for ALIMTA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ALIMTA For Injection pemetrexed disodium 750 mg/vial 021462 1 2016-10-06
ALIMTA For Injection pemetrexed disodium 1000 mg/vial 021462 1 2012-06-27
ALIMTA For Injection pemetrexed disodium 100 mg/vial 021462 1 2008-07-01
ALIMTA For Injection pemetrexed disodium 500 mg/vial 021462 2 2008-02-04

US Patents and Regulatory Information for ALIMTA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-002 Sep 7, 2007 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-001 Feb 4, 2004 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ALIMTA

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

International Patents for ALIMTA

See the table below for patents covering ALIMTA around the world.

Country Patent Number Title Estimated Expiration
Austria 135007 See Plans and Pricing
European Patent Office 1313508 COMPOSITION COMPRENANT UN ANTIFOLATE ET UN AGENT REDUCTEUR D'ACIDE METHYLMALONIQUE (COMBINATION CONTAINING AN ANTIFOLATE AND METHYLMALONIC ACID LOWERING AGENT) See Plans and Pricing
Australia 640182 See Plans and Pricing
China 1055182 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ALIMTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0432677 300181 Netherlands See Plans and Pricing 300181, 20101210, EXPIRES: 20151209
0432677 CA 2005 00008 Denmark See Plans and Pricing
0432677 C00432677/01 Switzerland See Plans and Pricing FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0432677 91147 Luxembourg See Plans and Pricing 91147, EXPIRES: 20151210
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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