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Last Updated: July 13, 2020

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ALIMTA Drug 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.

US ANDA Litigation and Generic Entry Outlook for Alimta

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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 24, 2022. This may change due to patent challenges or generic licensing.

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.

There are three tentative approvals for the generic drug (pemetrexed disodium), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for ALIMTA
Drug Prices for ALIMTA

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Generic Entry Opportunity Date for ALIMTA
Generic Entry Date for ALIMTA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;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.

Recent Clinical Trials for ALIMTA

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

SponsorPhase
NRG OncologyPhase 3
Calithera Biosciences, IncPhase 2
Roche Pharma AGPhase 2

See all ALIMTA clinical trials

Pharmacology for ALIMTA
Paragraph IV (Patent) Challenges for ALIMTA
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

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

Supplementary Protection Certificates for ALIMTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0432677 300181 Netherlands   Start Trial 300181, 20101210, EXPIRES: 20151209
0432677 CA 2005 00008 Denmark   Start Trial
0432677 C00432677/01 Switzerland   Start Trial FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
AstraZeneca
Merck
Medtronic
Harvard Business School
Express Scripts

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.