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Last Updated: December 9, 2019

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NEORAL Drug Profile

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Which patents cover Neoral, and when can generic versions of Neoral launch?

Neoral is a drug marketed by Novartis and is included in two NDAs.

The generic ingredient in NEORAL is cyclosporine. There are eighteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.

Drug patent expirations by year for NEORAL
Drug Prices for NEORAL

See drug prices for NEORAL

Recent Clinical Trials for NEORAL

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

SponsorPhase
Janssen-Cilag International NVPhase 1
Fred Hutchinson Cancer Research CenterPhase 2
National Cancer Institute (NCI)Phase 2

See all NEORAL clinical trials

Recent Litigation for NEORAL

Identify potential future generic entrants

District Court Litigation
Case NameDate
COSMO TECHNOLOGIES LIMITED v. ACTAVIS LABORATORIES FL, INC.2015-02-19
Petters Company, Inc.- Adversary Proceeding2010-10-08

See all NEORAL litigation

Synonyms for NEORAL
(3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-30-ethyl-33-((1R,2R,E)-1-hydroxy-2-methylhex-4-en-1-yl)-6,9,18,24-tetraisobutyl-3,21-diisopropyl-1,4,7,10,12,15,19,25,28-nonamethyl-1,4,7,10,13,16,1
(3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-30-ethyl-33-[(E,1R,2R)-1-hydroxy-2-methylhex-4-enyl]-1,4,7,10,12,15,19,25,28-nonamethyl-6,9,18,24-tetrakis(2-methylpropyl)-3,21-di(propan-2-yl)-1,4,7,10,13,16,19
(R-(R*,R*-(E)))-Cyclic(L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl-3-hydroxy-N,4-dimethyl-L-2-amino-6-octenoyl-L-alpha-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl)
(R-[R*,R*-(E)])-Cyclic(L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl-3-hydroxy-N,4-dimethyl-L-2-amino-6-octenoyl-L-alpha-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl)
1,11-cyclo[L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl-(E)-(2S,3R,4R)-2-amino-3-hydroxy-N,4-dimethyloct-6-enoyl-L-2-aminobutanoyl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucine]
104250-72-8
1c5f
1cyn
223528-56-1
2wfj
2z6w
30-Ethyl-33-((E)-1-hydroxy-2-methyl-hex-4-enyl)-6,9,18,24-tetraisobutyl-3,21-diisopropyl-1,4,7,10,12,15,19,28-octamethyl-1,4,7,10,13,16,19,22,25,28,31undecaaza-cyclotritriacontan-2,5,8,11,14,17,20,23,26,29,32-undecaone
30-Ethyl-33-(1-hydroxy-2-methyl-hex-4-enyl)-6,9,18,24-tetraisobutyl-3,21-diisopropyl-1,4,7,10,12,15,19,25,28-nonamethyl-1,4,7,10,13,16,19,22,25,28,31undecaaza-cyclotritriacontan-2,5,8,11,14,17,20,23,26,29,32-undecaone
30-ethyl-33-[(4E)-1-hydroxy-2-methylhex-4-en-1-yl]-6,9,18,24-tetraisobutyl-3,21-diisopropyl-1,4,7,10,12,15,19,25,28-nonamethyl-1,4,7,10,13,16,19,22,25,28,31-undecaazacyclotritriacontane-2,5,8,11,14,17,20,23,26,29,32-undecone
4jjm
56645-58-0
5946-EP0930075A1
5946-EP2289877A1
5946-EP2292601A1
5946-EP2292602A1
5946-EP2292603A1
5946-EP2292604A2
5946-EP2292618A1
5946-EP2293650A1
5946-EP2298737A1
5946-EP2298739A1
5946-EP2298740A1
5946-EP2298741A1
5946-EP2298771A2
5946-EP2301920A1
5946-EP2301940A1
5946-EP2308843A1
5946-EP2308861A1
59865-13-3
79217-60-0
83HN0GTJ6D
865C133
AB0090560
Abrammune
AC1NR4C4
AKOS015969287
AKOS015994720
Antibiotic S 7481F1
AOB2581
Arpimune ME
AT-12519
ATH-002
BDBM50022815
BMT-ABA-SAR-MLE-VAL-MLE-ALA-ALA-MLE-MLE-MVA
BMT-ABA-SAR-MLE-VAL-MLE-ALA-DAL-MLE-MLE-MVA
BPBio1_000496
BRD-K03222093-001-01-8
BRD-K13533483-001-03-0
BSPBio_000450
C042
C62H111N11O12
CAS-59865-13-3
CB-01-09 MMX
CCG-208184
CCRIS 1590
CHEBI:4031
CHEBI:92233
CHEMBL160
CicloMulsion
Cicloral (antibiotic)
Ciclosporin
Ciclosporin (Ciclosporin A)
Ciclosporin [INN]
Ciclosporin DT
Ciclosporin for system suitability, European Pharmacopoeia (EP) Reference Standard
Ciclosporin, European Pharmacopoeia (EP) Reference Standard
Ciclosporina
Ciclosporina [INN-Spanish]
Ciclosporina Germed
Ciclosporine
Ciclosporine [INN-French]
Ciclosporinum
Ciclosporinum [INN-Latin]
Cipol N
Cipol-N
Consupren
Consupren S
CSA
CsA & IFN.alpha.
CYA
Cyclo(((E)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl)-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl)
Cyclo(L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl-((3R,4R,6E)-6,7-didehydro-3-hydroxy-N,4-dimethyl-L-2-aminooctanoyl-L-2-aminobutanoyl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methylleucyl)
Cyclo(L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl-((3R,4R,6E)-6,7-didehydro-3-hydroxy-N,4-dimethyl-L-2-aminooctanoyl)-L-2-aminobutanoyl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methylleucyl)
Cyclo[[(E)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl]
Cyclokat
Cyclosporin
cyclosporin A
Cyclosporin A & IFN.alpha.
Cyclosporin A, >=98.5% (TLC)
Cyclosporin A, from Tolypocladium inflatum, >=95% (HPLC), solid
Cyclosporin A, from Tolypocladium inflatum, BioReagent, for molecular biology, >=95%
Cyclosporin A, VETRANAL(TM), analytical standard
CyclosporinA
cyclosporine
Cyclosporine [USAN:USP]
Cyclosporine A
Cyclosporine, Pharmaceutical Secondary Standard; Certified Reference Material
Cyclosporine, United States Pharmacopeia (USP) Reference Standard
DB00091
DE-076
Debio088
DRG-0275
DSSTox_CID_365
DSSTox_GSID_20365
DSSTox_RID_75541
DTXSID0020365
EBD2126862
Equoral
Gengraf
GTPL1024
HMS1569G12
HMS2089A09
HMS2096G12
HMS2230M14
HMS3713G12
HSDB 6881
Ikervis (opthalmic solution)
Imusporin
J10181
J90049
KS-1257
MFCD00274558
Mitogard
MLS000028376
MLS001333756
MLS002153454
MLS002207033
Modusik-A
MolPort-006-705-994
NCGC00016890-01
NCGC00093704-12
NCGC00164258-01
NCGC00164258-02
NCGC00164258-03
NCGC00255232-01
Neoplanta
Neoral, Sandimmune
NeuroSTAT
Nova-22007
NSC 290193
NSC290193
OL 27-400
OL-27400
OLO-400
Papilock
Papilock Mini
PMATZTZNYRCHOR-CGLBZJNRSA-N
Prestwick_731
Prestwick2_000435
Prestwick3_000435
Pulminiq
Q-200913
Ramihyphin A
Restasis
S 7481F1
S-Neoral
Sandimmun
Sandimmun Neoral
Sandimmune
Sandimmune Neoral
Sang 35
Sang-2000
Sang-35
SangCyA
SBI-0050230.P003
SCHEMBL3491
SCHEMBL4442
SDZ-OXL 400
Seciera
Sigmasporin
Sigmasporin Microoral
SMR000058578
SR-01000780563
SR-01000780563-3
ST-603
Tox21_110667
Tox21_110667_1
Tox21_301849
UNII-83HN0GTJ6D
Vekacia
Verkazia (opthalmic solution)
Zinograf ME
Zyclorin

US Patents and Regulatory Information for NEORAL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-001 Jul 14, 1995 AB1 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis NEORAL cyclosporine SOLUTION;ORAL 050716-001 Jul 14, 1995 AB1 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-003 Jul 14, 1995 DISCN Yes No   Start Trial   Start Trial   Start Trial
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-002 Jul 14, 1995 AB1 RX Yes Yes   Start Trial   Start Trial   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 NEORAL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-003 Jul 14, 1995   Start Trial   Start Trial
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-003 Jul 14, 1995   Start Trial   Start Trial
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-001 Jul 14, 1995   Start Trial   Start Trial
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-003 Jul 14, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Merck
AstraZeneca
Medtronic
Moodys
Dow
McKinsey

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