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.

The generic ingredient in ALIMTA is pemetrexed disodium. There are twenty-nine drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the pemetrexed disodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Alimta

A generic version of ALIMTA was approved as pemetrexed disodium by ACCORD HLTHCARE on May 25^th, 2022.

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Summary for ALIMTA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	344
Patent Applications:	6,227
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ALIMTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALIMTA
What excipients (inactive ingredients) are in ALIMTA?	ALIMTA excipients list
DailyMed Link:	ALIMTA at DailyMed

Drug patent expirations by year for ALIMTA

Recent Clinical Trials for ALIMTA

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

Sponsor	Phase
Regeneron Pharmaceuticals	Phase 2
Regeneron Pharmaceuticals	Phase 2/Phase 3
Liza Villaruz, MD	Phase 2

See all ALIMTA clinical trials

Pharmacology for ALIMTA

Drug Class	Folate Analog Metabolic Inhibitor
Mechanism of Action	Folic Acid Metabolism Inhibitors

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

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Glossary

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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	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462-001	Feb 4, 2004	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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

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Country	Patent Number	Title	Estimated Expiration
Luxembourg	91147		⤷ Sign Up
Australia	640524		⤷ Sign Up
Japan	2015178501	新規な葉酸代謝拮抗薬の組み合わせ療法 (NOVEL ANTIFOLATE COMBINATION THERAPIES)	⤷ Sign Up
Germany	122005000012		⤷ Sign Up
Singapore	48098	N-(pyrrolo[2,3-d]pyrimidin-3-ylacyl)-glutamic acid derivatives	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ALIMTA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0432677	CA 2005 00008	Denmark	⤷ Sign Up
0432677	C00432677/01	Switzerland	⤷ Sign Up	FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0432677	7/2005	Austria	⤷ Sign Up	PRODUCT NAME: PEMETREXED UND DESSEN PHARMAZEUTISCH ANNAHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/04/290/001 20040920
0432677	91147	Luxembourg	⤷ Sign Up	91147, EXPIRES: 20151210
0432677	SPC/GB05/011	United Kingdom	⤷ Sign Up	PRODUCT NAME: PEMETREXED AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/290/001 20040920
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description