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FDA Orange Book · active-ingredient family

Cyclosporine

Cyclosporine: 9 brands, 23 generics; first approved Nov 14, 1983; generic available.

Generic available2 exclusivity periodsHas discontinued products
Generic status & protection

Generic available — 23 ANDA applications approved.

Earliest patent expiry Jan 27, 2026Latest exclusivity ends Jun 23, 2028
Brands (NDA)
9
Generics (ANDA)
23
Listed patents
22
Next patent expiry
Jan 27, 2026
6 mo ago
Originator applications

Brand (NDA) products

VEVYERLDRS
NDA 2174692023
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.1%SOLUTIONOPHTHALMICRx—
VERKAZIARLDRS
NDA 2149652021
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.1%EMULSIONOPHTHALMICRx—
CEQUARLDRS
NDA 2109132018
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.09%SOLUTIONOPHTHALMICRx—
RESTASISRLDRS
NDA 05079020022 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.05%EMULSIONOPHTHALMICRxAB
0.05%EMULSIONOPHTHALMICRx—
NEORALRLD
NDA 05071519953 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
25MGCAPSULEORALRxAB1
100MGCAPSULEORALRxAB1
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULEORALDiscontinued—
NEORALRLDRS
NDA 0507161995
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
100MG/MLSOLUTIONORALRxAB1
SANDIMMUNERLD
NDA 05062519903 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
25MGCAPSULEORALRxAB2
100MGCAPSULEORALRxAB2
50MGCAPSULEORALRxBX
SANDIMMUNERLDRS
NDA 0505731983
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
50MG/MLINJECTABLEINJECTIONRxAP
SANDIMMUNERLDRS
NDA 0505741983
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
100MG/MLSOLUTIONORALRx—
Abbreviated applications

Generic (ANDA) products (23)

CYCLOSPORINE
ANDA 2192882026
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.05%EMULSIONOPHTHALMICRxAB
CYCLOSPORINE
ANDA 2090642026
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.05%EMULSIONOPHTHALMICRxAB
CYCLOSPORINE
ANDA 2119092025
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.05%EMULSIONOPHTHALMICRxAB
CYCLOSPORINE
ANDA 21904920252 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
25MGCAPSULEORALRxAB1
100MGCAPSULEORALRxAB1
CYCLOSPORINE
ANDA 2119432024
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.05%EMULSIONOPHTHALMICRxAB
CYCLOSPORINE
ANDA 2098112024
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.05%EMULSIONOPHTHALMICRxAB
CYCLOSPORINE
ANDA 2038802023
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.05%EMULSIONOPHTHALMICRxAB
CYCLOSPORINE
ANDA 2076062023
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.05%EMULSIONOPHTHALMICDiscontinued—
CYCLOSPORINE
ANDA 21604620223 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
25MGCAPSULEORALRxAB1
50MGCAPSULEORALRxAB1
100MGCAPSULEORALRxAB1
CYCLOSPORINE
ANDA 2058942022
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
0.05%EMULSIONOPHTHALMICRxAB
CYCLOSPORINE
ANDA 21072120193 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
25MGCAPSULEORALRxAB1
50MGCAPSULEORALRxAB1
100MGCAPSULEORALRxAB1
CYCLOSPORINE
ANDA 06511020053 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
50MGCAPSULEORALRxAB1
100MGCAPSULEORALRxAB1
25MGCAPSULEORALRxAB1
CYCLOSPORINE
ANDA 0650782005
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
100MG/MLSOLUTIONORALRxAB1
CYCLOSPORINE
ANDA 0651672005
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
100MG/MLSOLUTIONORALDiscontinued—
CYCLOSPORINE
ANDA 0651332004
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
100MG/MLSOLUTIONORALDiscontinued—
CYCLOSPORINE
ANDA 0651512003
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
50MG/MLINJECTABLEINJECTIONDiscontinued—
CYCLOSPORINE
ANDA 06504020022 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
25MGCAPSULEORALRxAB2
100MGCAPSULEORALRxAB2
CYCLOSPORINE
ANDA 0650542001
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
100MG/MLSOLUTIONORALDiscontinued—
CYCLOSPORINE
ANDA 06504420002 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
100MGCAPSULEORALRxAB1
25MGCAPSULEORALRxAB1
GENGRAF
ANDA 06500320003 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
25MGCAPSULEORALRxAB1
50MGCAPSULEORALDiscontinued—
100MGCAPSULEORALRxAB1
CYCLOSPORINE
ANDA 0650252000
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
100MG/MLSOLUTIONORALDiscontinued—
CYCLOSPORINE
ANDA 06501720002 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
100MGCAPSULEORALRxAB1
25MGCAPSULEORALRxAB1
CYCLOSPORINE
ANDA 0650041999
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
50MG/MLINJECTABLEINJECTIONRxAP
Protection horizon

Patent & exclusivity timeline

202620282030203220342036203820402042TodayPatent 11612658 — 2026-01-27Patent 11612658Patent 9220694 — 2026-01-27Patent 9220694Patent 9956289 — 2026-01-27Patent 9956289Patent 7973081 — 2026-01-27Patent 7973081Patent 8524779 — 2026-01-27Patent 8524779Exclusivity NP — 2026-05-30Exclusivity NPPatent 8298568 — 2027-11-03Patent 8298568Exclusivity ODE-358 — 2028-06-23Exclusivity ODE-358Patent 9132071 — 2029-06-02Patent 9132071Patent 8614178 — 2030-12-13Patent 8614178Patent 8292129 — 2031-02-25Patent 8292129Patent 8561859 — 2032-04-16Patent 8561859Patent 8980839 — 2033-08-23Patent 8980839Patent 9937225 — 2033-08-23Patent 9937225Patent 10441630 — 2033-08-23Patent 10441630Patent 9676525 — 2034-02-07Patent 9676525Patent 9669974 — 2034-05-11Patent 9669974Patent 12496326 — 2036-09-29Patent 12496326Patent 11951153 — 2037-02-28Patent 11951153Patent 10918694 — 2037-02-28Patent 10918694Patent 10813976 — 2037-09-22Patent 10813976Patent 11154513 — 2038-11-20Patent 11154513Patent 11413323 — 2039-10-11Patent 11413323Patent 12059449 — 2042-04-01Patent 12059449
Patent expiryExclusivity endToday
Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (2)

  • ODE-358Orphan-drug exclusivity (7 years)

    Jun 23, 2028

    in 2 yr

  • NPNew product exclusivity (3 years)

    May 30, 2026

    1 mo ago

Orange Book patent file

Listed patents

Listed patents (22)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11612658Jan 27, 20266 mo ago
U-3560
9220694Jan 27, 20266 mo ago
Product
9956289Jan 27, 20266 mo ago
Product
7973081Jan 27, 20266 mo ago
Product
8524779Jan 27, 20266 mo ago
Product
8298568Nov 03, 2027in 1 yr 4 mo
Product
9132071Jun 02, 2029in 2 yr 11 mo
Product
8614178Dec 13, 2030in 4 yr 6 mo
Product
8292129Feb 25, 2031in 4 yr 8 mo
ProductDelisted
8561859Apr 16, 2032in 5 yr 10 mo
ProductDelisted
8980839Aug 23, 2033in 7 yr 3 mo
ProductU-1483
9937225Aug 23, 2033in 7 yr 3 mo
ProductU-1483
10441630Aug 23, 2033in 7 yr 3 mo
Product
9676525Feb 07, 2034in 7 yr 8 mo
ProductDelisted
9669974May 11, 2034in 7 yr 11 mo
ProductDelisted
12496326Sep 29, 2036in 10 yr 4 mo
U-3627
11951153Feb 28, 2037in 10 yr 9 mo
U-1483
10918694Feb 28, 2037in 10 yr 9 mo
Product
10813976Sep 22, 2037in 11 yr 4 mo
Product
11154513Nov 20, 2038in 12 yr 6 mo
ProductU-1900
11413323Oct 11, 2039in 13 yr 5 mo
U-3627
12059449Apr 01, 2042in 15 yr 11 mo
ProductU-1483
FDA approval span

Approval history

First approval
Nov 14, 1983
43 yr 3 mo ago
Most recent approval
Jun 01, 2026
1 mo ago

Approvals span 1983–2026 across 32 FDA applications.

Brand (NDA) 928%
Generic (ANDA) 2372%

Cyclosporine — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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