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Last Updated: June 2, 2020

DrugPatentWatch Database Preview

RESTASIS Drug Profile


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

Restasis is a drug marketed by Allergan and is included in one NDA. There are ten patents protecting this drug.

This drug has one patent family member in one country.

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

US ANDA Litigation and Generic Entry Outlook for Restasis

A generic version of RESTASIS was approved as cyclosporine by WEST-WARD PHARMS INT on October 29th, 1999.

  Start Trial

Drug patent expirations by year for RESTASIS
Drug Prices for RESTASIS

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Drug Sales Revenue Trends for RESTASIS

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Recent Clinical Trials for RESTASIS

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

SponsorPhase
Singapore National Eye CentreEarly Phase 1
Health Science Authority SingaporeEarly Phase 1
Pavly MoawdPhase 3

See all RESTASIS clinical trials

Recent Litigation for RESTASIS

Identify potential future generic entrants

District Court Litigation
Case NameDate
Allergan, Inc. v. Amneal Pharmaceuticals LLC2018-09-20
Allergan, Inc. v. Saptalis Pharmaceuticals, LLC2018-08-10
Allergan, Inc. v. DEVA Holding A.S.2016-12-22

See all RESTASIS litigation

PTAB Litigation
PetitionerDate
2017-01-06
Argentum Pharmaceuticals LLC2016-06-22
2016-06-03

See all RESTASIS litigation

Synonyms for RESTASIS
(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-undecaazacyclotritriaco
(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-undeca
(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-di(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]-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-undecaazacyclotritriac
(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-undecazacyclotritriaconta
(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-undecazacyc
(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]
1c5f
1cyn
2wfj
2z6w
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-undecaazacyclotr
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-2,5,8,11,14,17,20,23,2
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
32-ethyl-2-[(e,1r,2r)-1-hydroxy-2-methylhex-4-enyl]-3,6,9,12,14,17,21,27,30-nonamethyl-8,11,20,26-tetrakis-(2-methylpropyl)-5,23-di-(propan-2-yl)-3,6,9,12,15,18,21,24,27,30,33-undecaza-cyclotritriacontane-1,4,7,10,13,16,19,2
4jjm
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
AB01566822_01
AB2000137
Abrammune
AKOS015969287
Antibiotic S 7481F1
ANTIBIOTIC S-7481F1
AOB2581
AOB5973
Arpimune ME
AS-15704
AT-12519
ATH-002
Atopica
BDBM50022815
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
Ciclosporin;
Ciclosporina
Ciclosporina [INN-Spanish]
Ciclosporina Germed
Ciclosporine
Ciclosporine [INN-French]
Ciclosporinum
Ciclosporinum [INN-Latin]
Cipol N
Cipol-N
Consupren
Consupren S
CS-2761
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
Cyclosporin-A(Cyclosporine-A)
CyclosporinA
cyclosporine
Cyclosporine (Neoral)
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
HY-B0579
Ikervis (opthalmic solution)
Imusporin
itriacontan-2,5,8,11,14,17,20,23,26,29,32-undecaone
J10181
J90049
KS-1257
LS-58836
MFCD00274558
Mitogard
MLS000028376
MLS001333756
MLS002153454
MLS002207033
Modusik-A
NCGC00016890-01
NCGC00093704-12
NCGC00164258-01
NCGC00164258-02
NCGC00164258-03
NCGC00255232-01
Neoplanta
Neoral
NeuroSTAT
Nova-22007
NSC 290193
NSC-290193
NSC290193
OL 27-400
OL-27-400
OL-27400
OLO-400
Optimmune
Papilock
Papilock Mini
PMATZTZNYRCHOR-CGLBZJNRSA-N
Prestwick_731
Prestwick2_000435
Prestwick3_000435
Pulminiq
Q-200913
Q367700
Ramihyphin A
S 7481F1
S-Neoral
s1514
Sandimmun
Sandimmun Neoral
Sandimmune
Sandimmune Neoral
Sandimmune;Gengraf;Restasis;Atopica;Sangcya;Neoral
Sang 35
Sang-2000
Sang-35
SangCyA
SBI-0050230.P003
SCHEMBL3491
SCHEMBL4331439
SCHEMBL4442
SCHEMBL4454089
SDZ-OXL 400
SDZ-OXL-400
Seciera
Sigmasporin
Sigmasporin Microoral
SMR000058578
SR-01000780563
SR-01000780563-3
ST-603
SW219558-1
Tox21_110667
Tox21_110667_1
Tox21_301849
UNII-83HN0GTJ6D
Vekacia
Verkazia (opthalmic solution)
Zinograf ME
Zyclorin

US Patents and Regulatory Information for RESTASIS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan RESTASIS cyclosporine EMULSION;OPHTHALMIC 050790-001 Dec 23, 2002 RX Yes Yes   Start Trial   Start Trial   Start Trial
Allergan RESTASIS MULTIDOSE cyclosporine EMULSION;OPHTHALMIC 050790-002 Oct 27, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Allergan RESTASIS cyclosporine EMULSION;OPHTHALMIC 050790-001 Dec 23, 2002 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan RESTASIS MULTIDOSE cyclosporine EMULSION;OPHTHALMIC 050790-002 Oct 27, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan RESTASIS MULTIDOSE cyclosporine EMULSION;OPHTHALMIC 050790-002 Oct 27, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Allergan RESTASIS MULTIDOSE cyclosporine EMULSION;OPHTHALMIC 050790-002 Oct 27, 2016 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

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Serving leading biopharmaceutical companies globally:

Dow
Medtronic
Boehringer Ingelheim
Harvard Business School
Mallinckrodt
Baxter

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 verification 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.