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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Teva
Deloitte
Healthtrust
Boehringer Ingelheim
Fuji
US Department of Justice
Daiichi Sankyo
Chubb

Generated: August 17, 2018

DrugPatentWatch Database Preview

Cyclosporine - Generic Drug Details

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

Cyclosporine is the generic ingredient in six branded drugs marketed by Apotex, Ivax Sub Teva Pharms, Mayne Pharma, Sandoz, Abbvie, Novartis, Allergan, Luitpold, West-ward Pharms Int, Apotex Inc, and Wockhardt Bio Ag, and is included in eighteen NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cyclosporine has thirty-five patent family members in thirteen countries.

There are eighteen drug master file entries for cyclosporine. Thirteen suppliers are listed for this compound.

Synonyms for cyclosporine
(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-((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-1,4,7,10,13,16,19,22,25,28,31-undecaazacyclotritriacon
(3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-30-ethyl-33-[(1R,2R,4E)-1-hydroxy-2-methylhex-4-en-1-yl]-1,4,7,10,12,15,19,25,28-nonamethyl-6,9,18,24-tetrakis(2-methylpropyl)-3,21-bis(propan-2-yl)-1,4,7,10,13,16,19,22,25,28,31-undecaa
(3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-30-ETHYL-33-[(1R,2R,4E)-1-HYDROXY-2-METHYLHEX-4-EN-1-YL]-3,21-DIISOPROPYL-1,4,7,10,12,15,19,25,28-NONAMETHYL-6,9,18,24-TETRAKIS(2-METHYLPROPYL)-1,4,7,10,13,16,19,22,25,28,31-UNDECAAZACYC
(3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-30-ethyl-33-[(1R,2R,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-undecaazacyclotritriaco
(3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-30-ethyl-33-[(E,1R,2R)-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-1,4,7,10,13,16,19,22,25,28,31-undecazacyclotritriacontan
(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
(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)-1,4,7,10,13,16,19,22,25,28,31-undecazacycl
(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]-1,4,7,10,12,15,19,25,28-nonamethyl-6,9,18,24-tetrakis(2-methylpropyl)-3,21-bis(propan-2-yl)-1,4,7,10,13,16,19,22,25,28,31-undecaazacyclotritriacontane-2,5,8,11,14,17,20,23,26
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
55126-45-9
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
AM000530
Ambap59865-13-3
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
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 0.1 mg/ml in Acetonitrile
Ciclosporin 1.0 mg/ml in Acetonitrile
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 [USAN:USP]
Cyclosporine A
Cyclosporine, pharmaceutical secondary standard; traceable to USP and PhEur
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
HSDB 6881
Ikervis
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
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
ST-603
Tox21_110667
Tox21_110667_1
Tox21_301849
UNII-83HN0GTJ6D
Vekacia
Zinograf ME
Zyclorin

US Patents and Regulatory Information for cyclosporine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz CYCLOSPORINE cyclosporine CAPSULE;ORAL 065017-001 Jan 13, 2000 AB1 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Allergan RESTASIS cyclosporine EMULSION;OPHTHALMIC 050790-001 Dec 23, 2002 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mayne Pharma CYCLOSPORINE cyclosporine CAPSULE;ORAL 065044-002 Dec 20, 2000 AB1 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Allergan RESTASIS cyclosporine EMULSION;OPHTHALMIC 050790-001 Dec 23, 2002 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Allergan RESTASIS MULTIDOSE cyclosporine EMULSION;OPHTHALMIC 050790-002 Oct 27, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for cyclosporine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis NEORAL cyclosporine SOLUTION;ORAL 050716-001 Jul 14, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-002 Jul 14, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-001 Jul 14, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis NEORAL cyclosporine CAPSULE;ORAL 050715-002 Jul 14, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis SANDIMMUNE cyclosporine CAPSULE;ORAL 050625-001 Mar 2, 1990 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for cyclosporine

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
8,618,064 Methods of providing therapeutic effects using cyclosporin components ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Cerilliant
Cipla
McKinsey
Healthtrust
AstraZeneca
Medtronic
Chubb
Harvard Business School

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.