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ALIMTA Drug Profile

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When do Alimta patents expire, and what generic alternatives are available?

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 seventeen 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.

Summary for ALIMTA

International Patents:	17
US Patents:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	99
Clinical Trials:	162
Patent Applications:	3,978
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALIMTA
DailyMed Link:	ALIMTA at DailyMed

Pharmacology for ALIMTA

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

Medical Subject Heading (MeSH) Categories for ALIMTA

Antineoplastic Agents

Enzyme Inhibitors

Folic Acid Antagonists

Nucleic Acid Synthesis Inhibitors

Synonyms for ALIMTA

(2S)-2-[[4-[2-(2-amino-4-oxo-1,7-dihydropyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]amino]pentanedioic acid

(2S)-2-{[4-(2-{2-amino-4-oxo-1H,4H,7H-pyrrolo[2,3-d]pyrimidin-5-yl}ethyl)phenyl]formamido}pentanedioic acid

(S)-2-(4-(2-(2-Amino-4-oxo-4,7-dihydro-1H-pyrrolo-[2,3-d]pyrimidin-5-yl)ethyl)benzamido)pentanedioic acid

(S)-2-(4-(2-(2-Amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl)benzamido)pentanedioic

(S)-2-(4-(2-(2-Amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl)benzamido)pentanedioic acid

(S)-2-(4-(2-(2-amino-4-oxo-4,7-dihydro-3H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl)benzamido)pentanedioic acid

04Q9AIZ7NO

137281-23-3

150399-23-8

1juj

2-{4-[2-(2-AMINO-4-OXO-4,7-DIHYDRO-3H-PYRROLO[2,3-D]PYRIMIDIN-5-YL)-ETHYL]-BENZOYLAMINO}-PENTANEDIOIC ACID

281P233

2PKU919BA9

357166-30-4

41413-EP2270012A1

41413-EP2270013A1

41413-EP2305681A1

41413-EP2311838A1

41421-EP2270012A1

41421-EP2270013A1

41421-EP2305681A1

41421-EP2311838A1

4DW

89077-EP2270012A1

89077-EP2270013A1

89077-EP2305681A1

AB01273937-01

AC-1326

AC-1701

AC1L9JT6

AC1OCF51

AJ-26845

AK-72902

AK325951

AKOS015896253

AKOS025149477

AKOS025392176

Alimta (TN) (Lilly)

BC215781

BDBM18796

BDBM50027656

BG0632

BR-72902

C20H19N5Na2O6

C20H19N5O6.2Na.7H2O

C20H21N5O6

CAS-150399-23-8

CCG-213071

CCG-221272

CHEBI:63616

CHEBI:63722

CHEMBL225072

CHEMBL2360464

CP0067

CP0119

CS-1297

CS-1298

CS-W004541

CTK8E6673

D03828

D07472

DB-024764

DB00642

disodium (2S)-2-({4-[2-(2-amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl}amino)pentanedioate

disodium (2S)-2-[[4-[2-(2-amino-4-oxo-1,7-dihydropyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]amino]pentanedioate

Disodium N-(p-(2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo(2,3-d)pyrimidin-5-yl)ethyl)benzoyl)-L-glutamate

disodium N-{4-[2-(2-amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl}-L-glutamate

DSSTox_CID_26660

DSSTox_GSID_46660

DSSTox_RID_81803

DTXSID2048329

DTXSID8046660

EX-A836

FT-0659328

H518

HMS3264H07

HSDB 7316

HY-10820

HY-10820A

I06-2128

J-502393

KB-78231

KB-79792

KS-00000GW0

KS-00000XJK

KS-5001

L-Glutamic acid, N-(4-(2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo(2,3-d)pyrimidin-5-yl)ethyl)benzoyl)-

L-Glutamic acid,3-d]pyrimidin-5-yl]ethyl]benzoyl]-

LY-2315

LY-231514

LY231514

LY231514 disodium

LYA

MolPort-003-849-796

MolPort-016-638-470

MolPort-020-179-988

N-(4-[2-(2-amino-4,7-Dihydro-4-Oxo-1H-Pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl)-L-Glutamic Acid

N-(4-[2-(2-Amino-4,7-Dihydro-4-Oxo-1H-Pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl)-L-Glutamic Acid Disodium Salt

N-(4-[2-(2-Amino-4,7-Dihydro-4-Oxo-1H-Pyrrolo[2,3-d]pyrimidin-5yl)ethyl]benzoyl)-L-Glutamic Acid Disodium Salt

N-[4-[2-(2-amino-3,4-dihydro-4-oxo-7h-pyrrolo[2,3-d]pyrimi-din-5-yl)ethyl]benzoyl]l-glutamic acid

N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid

N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid disodium salt

N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2.3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid disodium salt

N-[4-[2-(2-amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid

N-[4-[2-[2-Amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-d]pyrimidin-5-yl]ethyl]benzoyl]glutamic acid

N-[4-[2(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo [2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid

N-[4-[2(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid

N-[4[2-(-amino-3,4-dihydro-4-oxo-7h-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-l-glutamate sodium salt

N-{4-[2-(2-amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl}-L-glutamic acid

N-{4-[2-(2-Amino-4-Oxo-4,7-Dihydro-3h-Pyrrolo[2,3-D]pyrimidin-5-Yl)ethyl]benzoyl}-L-Glutamic Acid

NCGC00167486-01

NCGC00167517-01

NCGC00242485-01

NSC-698037

NSC698037

NYDXNILOWQXUOF-GXKRWWSZSA-L

P2288

Pemetrexed

Pemetrexed (disodium)

Pemetrexed (INN)

Pemetrexed (TN)

Pemetrexed acid

pemetrexed diacid monohydrate

Pemetrexed disodium

Pemetrexed disodium (USAN)

Pemetrexed disodium [USAN]

PEMETREXED DISODIUM 5/2 hydrate

Pemetrexed disodium salt

Pemetrexed disodium, anhydrous

Pemetrexed Na

Pemetrexed Sodium

Pemetrexed sodium hydrate

Pemetrexeddisodium

Premetred disodium

Premetrexed [Common mis-spelling]

Rolazar

RP17940

RP17947

S-4927

s1135

SC-25136

SCHEMBL18348

SCHEMBL7968

sodium (S)-2-(4-(2-(2-amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl)benzamido)pentanedioate

Tifolar

Tox21_112487

UNII-04Q9AIZ7NO

UNII-2PKU919BA9

WBXPDJSOTKVWSJ-ZDUSSCGKSA-N

X5918

ZINC1540998

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	INJECTABLE;IV (INFUSION)	021462-002	Sep 7, 2007		RX	Yes	Yes					Y
Lilly	ALIMTA	pemetrexed disodium	INJECTABLE;IV (INFUSION)	021462-001	Feb 4, 2004		RX	Yes	Yes					Y

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Expired US Patents for ALIMTA

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

Paragraph IV (Patent) Challenges for ALIMTA

Drugname	Dosage	Strength	RLD	Submissiondate
	For Injection	750 mg/vial		2016-10-06
	For Injection	1000 mg/vial		2012-06-27
	For Injection	100 mg/vial		2008-07-01
	For Injection	500 mg/vial		2008-02-04

Non-Orange Book US Patents for ALIMTA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,053,065	Vitamin B12 and pemetrexed disodium combination therapies

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International Patents for ALIMTA

Country	Document Number	Estimated Expiration
Japan	2004501964
Cyprus	1107649
Slovenia	1313508
Japan	2015178501

Supplementary Protection Certificates for ALIMTA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2005	Austria		PRODUCT NAME: PEMETREXED UND DESSEN PHARMAZEUTISCH ANNAHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/04/290/001 20040920
C/GB05/011	United Kingdom		PRODUCT NAME: PEMETREXED AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/290/001 20040920