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ALIMTA Drug Profile

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 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:	18
Clinical Trials:	168
Patent Applications:	4,284
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ALIMTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALIMTA
DailyMed Link:	ALIMTA at DailyMed

Drug patent expirations by year for ALIMTA

Generic Entry Opportunity Date for ALIMTA

Generic Entry Date for ALIMTA^: ➤ Sign Up* Constraining patent/regulatory exclusivity: ➤ Sign Up NDA: 021462 Dosage: INJECTABLE;IV (INFUSION)

^*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.

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

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

Paragraph IV (Patent) Challenges for ALIMTA

Drugname	Dosage	Strength	RLD	Date
➤ Subscribe	For Injection	750 mg/vial	➤ Subscribe	➤ Sign Up
➤ Subscribe	For Injection	1000 mg/vial	➤ Subscribe	➤ Sign Up
➤ Subscribe	For Injection	100 mg/vial	➤ Subscribe	➤ Sign Up
➤ Subscribe	For Injection	500 mg/vial	➤ Subscribe	➤ Sign Up

International Patents for ALIMTA

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Country	Document Number	Estimated Expiration
European Patent Office	1313508	➤ Sign Up
Denmark	1313508	➤ Sign Up
Spain	2284660	➤ Sign Up
Australia	6968801	➤ Sign Up
Japan	2004501964	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for ALIMTA

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