Orange Book product · Brand (NDA)
RESTASIS MULTIDOSE
CYCLOSPORINE
At a glance
Oct 27, 2016
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 27, 2016
9 yr 9 mo ago
Today
Patent 8292129 expires
Listed drug product patent expiration.
Feb 25, 2031
in 4 yr 9 mo
Patent 8561859 expires
Listed drug product patent expiration.
Apr 16, 2032
in 5 yr 11 mo
Patent 9676525 expires
Listed drug product patent expiration.
Feb 07, 2034
in 7 yr 9 mo
Patent 9669974 expires
Listed drug product patent expiration.
May 11, 2034
in 8 yr
Pharmaceutical detail
Active ingredient
CYCLOSPORINE
Strength
0.05%
Dosage form
EMULSION
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 050790
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2023VEVYEBrand (NDA)
NDA 217469 · HARROW EYE
- 2021VERKAZIABrand (NDA)
NDA 214965 · HARROW EYE
- 2018CEQUABrand (NDA)
NDA 210913 · SUN PHARM
- 1995NEORALBrand (NDA)
NDA 050715 · NOVARTIS
- 1995NEORALBrand (NDA)
NDA 050716 · NOVARTIS
- 1990SANDIMMUNEBrand (NDA)
NDA 050625 · NOVARTIS
- 1983SANDIMMUNEBrand (NDA)
NDA 050573 · NOVARTIS
- 1983SANDIMMUNEBrand (NDA)
NDA 050574 · NOVARTIS
- 2026CYCLOSPORINEGeneric (ANDA)
ANDA 219288 · JIANGSU ANBISON
- 2026CYCLOSPORINEGeneric (ANDA)
ANDA 209064 · TWI PHARMS
- 2025CYCLOSPORINEGeneric (ANDA)
ANDA 211909 · AMNEAL
- 2025CYCLOSPORINEGeneric (ANDA)
ANDA 219049 · QILU
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8292129 | Feb 25, 2031 | in 4 yr 9 mo | ProductDelisted |
| 8561859 | Apr 16, 2032 | in 5 yr 11 mo | ProductDelisted |
| 9676525 | Feb 07, 2034 | in 7 yr 9 mo | ProductDelisted |
| 9669974 | May 11, 2034 | in 8 yr | ProductDelisted |
