ALIMTA Drug Patent Profile

Which patents cover Alimta, 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.

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

See drug prices 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

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

Expired US Patents for ALIMTA

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

International Patents for ALIMTA

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

Country	Patent Number	Title	Estimated Expiration
South Africa	9009631
Spain	2077808
Russian Federation	2057131	ПРОИЗВОДНЫЕ N-(ПИРРОЛО[2,3-D]ПИРИМИДИН-3-ИЛАЦИЛ)-L-ГЛУТАМИНОВОЙ КИСЛОТЫ, ИЛИ ИХ ТАУМЕРЫ, ИЛИ ИХ ФАРМАЦЕВТИЧЕСКИ ПРИЕМЛЕМЫЕ СОЛИ И СПОСОБ ИХ ПОЛУЧЕНИЯ (DERIVATIVES OF N-(PYRROLO[2,3-D]PYRIMIDINE-3-YLACYL)-L-GLYTAMICE ACID OR THEIR TAUTOMERS, OR THEIR PHARMACEUTICALLY ACCEPTABLE SALTS, AND METHOD FOR THEIR PREPARING)
Austria	359823
Australia	640182

Supplementary Protection Certificates for ALIMTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0432677	SPC/GB05/011	United Kingdom		PRODUCT NAME: PEMETREXED AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/290/001 20040920
0432677	7/2005	Austria		PRODUCT NAME: PEMETREXED UND DESSEN PHARMAZEUTISCH ANNAHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/04/290/001 20040920
0432677	91147	Luxembourg		91147, EXPIRES: 20151210
0432677	300181	Netherlands		300181, 20101210, EXPIRES: 20151209
0432677	C00432677/01	Switzerland		FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH