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Last Updated: December 12, 2019

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Pemetrexed disodium - Generic Drug Details

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What are the generic drug sources for pemetrexed disodium and what is the scope of freedom to operate?

Pemetrexed disodium is the generic ingredient in one branded drug marketed by Lilly and is included in one NDA. There is one patent protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Pemetrexed disodium has eighteen patent family members in eleven countries.

There are twenty-nine drug master file entries for pemetrexed disodium. One supplier is listed for this compound. There are two tentative approvals for this compound.

Recent Clinical Trials for pemetrexed disodium

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

SponsorPhase
University of California, San FranciscoPhase 2
Merck Sharp & Dohme Corp.Phase 2
Sun Yat-sen UniversityPhase 2

See all pemetrexed disodium clinical trials

Recent Litigation for pemetrexed disodium

Identify potential future generic entrants

District Court Litigation
Case NameDate
Eli Lilly and Company v. Eagle Pharmaceuticals, Inc.2017-09-11
ELI LILLY AND COMPANY v. HOSPIRA, INC.2016-12-21
ELI LILLY AND COMPANY v. DR. REDDY'S LABORATORIES, LTD.2016-02-05

See all pemetrexed disodium litigation

PTAB Litigation
PetitionerDate
Apotex Inc.2016-07-14
Wockhardt Bio AG2016-07-08
Apotex Inc.2016-07-01

See all pemetrexed disodium litigation

Generic filers with tentative approvals for PEMETREXED DISODIUM
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial500MGINJECTABLE;INJECTION
  Start Trial  Start Trial100MGINJECTABLE;INJECTION
  Start Trial  Start Trial100MGINJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for pemetrexed disodium
Medical Subject Heading (MeSH) Categories for pemetrexed disodium
Synonyms for pemetrexed disodium
(2S)-2-[[4-[2-(2-amino-4-oxo-1,7-dihydropyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]amino]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
357166-29-1
357166-30-4
399P238
41413-EP2270012A1
41413-EP2270013A1
41413-EP2305681A1
41413-EP2311838A1
41421-EP2270012A1
41421-EP2270013A1
41421-EP2305681A1
41421-EP2311838A1
4DW
89077-EP2270012A1
89077-EP2270013A1
89077-EP2305681A1
89080-EP2270013A1
89080-EP2305681A1
9T47E4OM16
AB01273937-01
AC-1326
AC-15436
AC-1701
AC-23353
AC-8339
AC1L9JT6
AC1OCF51
AJ-26845
AK-72902
AK325951
AKOS015896253
AKOS015961984
AKOS016005851
AKOS016340523
AKOS025149477
AKOS025392176
Alimta
Alimta (TN)
Alimta (TN) (Lilly)
AN-28733
AN-28734
API0024628
AS-17891
AS-30680
BC215781
BC216030
BCP22709
BDBM50027656
BG0632
BR-72902
C20H19N5Na2O6
C20H19N5O6.2Na.7H2O
C20H21N5O6
C40H48N10Na4O17
CAS-150399-23-8
CCG-213071
CCG-221272
CHEBI:63616
CHEBI:63722
CHEBI:63723
CHEMBL225072
CHEMBL2360464
CP0067
CP0119
CS-1297
CS-1298
CS-W004541
CTK8E6673
D03828
D06503
D07472
D10596
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 (2S)-2-[[4-[2-(2-amino-4-oxo-1,7-dihydropyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]amino]pentanedioate heptahydrate
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
disodium N-{4-[2-(2-amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl}-L-glutamate--water (1/7)
disodium;(2S)-2-[[4-[2-(2-amino-4-oxo-1,7-dihydropyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]amino]pentanedioate;heptahydrate
DSSTox_CID_26660
DSSTox_GSID_46660
DSSTox_RID_81803
DTXSID10189239
DTXSID2048329
DTXSID50189238
DTXSID8046660
EX-A836
F4GSH45R4C
FT-0659328
FT-0689445
H518
HMS3264H07
HMS3715P06
HSDB 7316
HY-10820
HY-10820A
I06-2128
J-502393
KB-303015
KB-78231
KB-79792
KB-79793
KS-00000GW0
KS-00000XJK
KS-00001092
KS-1185
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, N-(4-(2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo(2,3-d)pyrimidin-5-yl)ethyl)benzoyl)-, disodium salt
L-Glutamic acid, N-(4-(2-(2-amino-4,7-dihydro-4-oxo-3H-pyrrolo(2,3-d)pyrimidin-5-yl)ethyl)benzoyl)-, sodium salt, hydrate (2:4:5)
L-Glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4- 8 oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-, disodium salt, heptahydrate
L-Glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-, disodium salt, heptahydrate
L-Glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-
L-Glutamic acid,3-d]pyrimidin-5-yl]ethyl]benzoyl]-
LY 231,514
LY 231514
LY-2315
LY-231514
LY-231514 Disodium Hydrate
LY231514
LY231514 disodium
LYA
MolPort-003-849-796
MolPort-005-935-364
MolPort-016-638-470
MolPort-020-179-988
MolPort-023-220-664
MolPort-028-744-755
MolPort-046-033-448
N-({4-[2-(2-amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]phenyl}carbonyl)-L-glutamic acid
N-(4-(2-(2-Amino-3,4-dihydro-4-oxo-7H-pyrrolo(2,3-d)pyrimdin-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 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
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 hydrate
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]-L-glutamic Acid Disodium Salt Heptahydrate
N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid disodium salt hydrate
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
NCGC00167486-01
NCGC00167517-01
NCGC00242485-01
NSC-698037
NSC698037
NYDXNILOWQXUOF-GXKRWWSZSA-L
P2288
Pemetrexed
Pemetrexed (disodium)
Pemetrexed (INN)
Pemetrexed (TN)
Pemetrexed [INN:BAN]
Pemetrexed accord (TN)
Pemetrexed acid
Pemetrexed disodium (USAN)
Pemetrexed disodium [USAN]
Pemetrexed disodium 2.5 hydrate
PEMETREXED DISODIUM 5/2 hydrate
Pemetrexed disodium hemipentahydrate
Pemetrexed disodium heptahydrate
Pemetrexed disodium hepthydrate
Pemetrexed disodium hydrate
Pemetrexed disodium salt
Pemetrexed Disodium Salt Heptahydrate
Pemetrexed disodium, anhydrous
Pemetrexed sodium hemipentahydrate (JAN)
Pemetrexed sodium hydrate
Pemetrexed sodium hydrate (2:4:5)
Pemetrexed sodium hydrate (JAN)
Premetred disodium
Premetrexed [Common mis-spelling]
QJVSMHJWAOSBMD-MYXYZBIASA-L
Rolazar
RP17940
RP17947
S-4927
s1135
SC-22444
SC-25136
SCHEMBL108860
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
tetrasodium (2S)-2-[[4-[2-(2-amino-4-oxo-1,7-dihydropyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]amino]pentanedioate pentahydrate
Tifolar
Tox21_112487
UNII-04Q9AIZ7NO
UNII-2PKU919BA9
UNII-9T47E4OM16
UNII-F4GSH45R4C
US9422297, Pemetrexed
V2356
WBXPDJSOTKVWSJ-ZDUSSCGKSA-N
X5918
ZCTCZKWJFTYNMZ-WKUCUCPSSA-J
ZINC1540998
Paragraph IV (Patent) Challenges for PEMETREXED DISODIUM
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 pemetrexed disodium

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 021462-001 Feb 4, 2004 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-002 Sep 7, 2007 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 pemetrexed disodium

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
Lilly ALIMTA pemetrexed disodium POWDER;INTRAVENOUS 021462-002 Sep 7, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for pemetrexed disodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0432677 7/2005 Austria   Start Trial PRODUCT NAME: PEMETREXED UND DESSEN PHARMAZEUTISCH ANNAHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/04/290/001 20040920
0432677 SPC/GB05/011 United Kingdom   Start Trial 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

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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 verifification 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.