FDA Orange Book · active-ingredient family
Cyclosporine
Cyclosporine is approved as 9 brand and 23 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VEVYE · NDA 217469
9
Brand (NDA)
23
Generics (ANDA)
22
Listed patents
2
Exclusivity periods
Brand (NDA) products · capsule, emulsion, injectable, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VEVYERLD | HARROW EYE | NDA 217469 | — | May 30, 2023 | |
| VERKAZIARLD | HARROW EYE | NDA 214965 | — | Jun 23, 2021 | |
| CEQUARLD | SUN PHARM | NDA 210913 | — | Aug 14, 2018 | |
| RESTASISRLD×2 | ABBVIE | NDA 050790 | AB | Dec 23, 2002 | |
| NEORALRLD×3 | NOVARTIS | NDA 050715 | AB1 | Jul 14, 1995 | |
| NEORALRLD | NOVARTIS | NDA 050716 | AB1 | Jul 14, 1995 | |
| SANDIMMUNERLD×3 | NOVARTIS | NDA 050625 | AB2 | Mar 02, 1990 | |
| SANDIMMUNERLD | NOVARTIS | NDA 050573 | AP | Nov 14, 1983 | |
| SANDIMMUNERLD | NOVARTIS | NDA 050574 | — | Nov 14, 1983 |
Generic (ANDA) products (23)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CYCLOSPORINE | JIANGSU ANBISON | ANDA 219288 | AB | Jun 01, 2026 | |
| CYCLOSPORINE | TWI PHARMS | ANDA 209064 | AB | Jan 21, 2026 | |
| CYCLOSPORINE | AMNEAL | ANDA 211909 | AB | Nov 28, 2025 | |
| CYCLOSPORINE×2 | QILU | ANDA 219049 | AB1 | Sep 15, 2025 | |
| CYCLOSPORINE | SAPTALIS PHARMS | ANDA 211943 | AB | Jul 05, 2024 | |
| CYCLOSPORINE | DEVA HOLDING AS | ANDA 209811 | AB | May 21, 2024 | |
| CYCLOSPORINE | TEVA PHARMS USA INC | ANDA 203880 | AB | Dec 14, 2023 | |
| CYCLOSPORINE | APOTEX | ANDA 207606 | — | Jan 12, 2023 | |
| CYCLOSPORINE×3 | ONESOURCE SPECIALTY | ANDA 216046 | AB1 | Aug 02, 2022 | |
| CYCLOSPORINE | MYLAN | ANDA 205894 | AB | Feb 02, 2022 | |
| CYCLOSPORINE×3 | APOTEX | ANDA 210721 | AB1 | Jul 10, 2019 | |
| CYCLOSPORINE×3 | IVAX SUB TEVA PHARMS | ANDA 065110 | AB1 | Mar 29, 2005 | |
| CYCLOSPORINE | IVAX SUB TEVA PHARMS | ANDA 065078 | AB1 | Mar 25, 2005 | |
| CYCLOSPORINE | PHARM ASSOC | ANDA 065167 | — | Jan 05, 2005 | |
| CYCLOSPORINE | PHARMOBEDIENT CNSLTG | ANDA 065133 | — | Sep 17, 2004 | |
| CYCLOSPORINE | PADAGIS US | ANDA 065151 | — | Oct 07, 2003 | |
| CYCLOSPORINE×2 | APOTEX | ANDA 065040 | AB2 | May 09, 2002 | |
| CYCLOSPORINE | DR REDDYS LABS SA | ANDA 065054 | — | Dec 18, 2001 | |
| CYCLOSPORINE×2 | DR REDDYS LABS SA | ANDA 065044 | AB1 | Dec 20, 2000 | |
| GENGRAF×3 | ABBVIE | ANDA 065003 | AB1 | May 12, 2000 | |
| CYCLOSPORINE | ABBVIE | ANDA 065025 | — | Mar 03, 2000 | |
| CYCLOSPORINE×2 | SANDOZ | ANDA 065017 | AB1 | Jan 13, 2000 | |
| CYCLOSPORINE | HIKMA | ANDA 065004 | AP | Oct 29, 1999 |
Marketing exclusivity (2)
- ODE-358Orphan-drug exclusivity (7 years)
Jun 23, 2028
in 2 yr 1 mo
- NPNew product exclusivity (3 years)
May 30, 2026
20 d ago
Listed patents (22)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11612658 | Jan 27, 2026 | 5 mo ago | U-3560 |
| 9220694 | Jan 27, 2026 | 5 mo ago | Product |
| 9956289 | Jan 27, 2026 | 5 mo ago | Product |
| 7973081 | Jan 27, 2026 | 5 mo ago | Product |
| 8524779 | Jan 27, 2026 | 5 mo ago | Product |
| 8298568 | Nov 03, 2027 | in 1 yr 5 mo | Product |
| 9132071 | Jun 02, 2029 | in 3 yr | Product |
| 8614178 | Dec 13, 2030 | in 4 yr 7 mo | Product |
| 8292129 | Feb 25, 2031 | in 4 yr 9 mo | ProductDelisted |
| 8561859 | Apr 16, 2032 | in 5 yr 11 mo | ProductDelisted |
| 8980839 | Aug 23, 2033 | in 7 yr 3 mo | ProductU-1483 |
| 9937225 | Aug 23, 2033 | in 7 yr 3 mo | ProductU-1483 |
| 10441630 | Aug 23, 2033 | in 7 yr 3 mo | Product |
| 9676525 | Feb 07, 2034 | in 7 yr 9 mo | ProductDelisted |
| 9669974 | May 11, 2034 | in 8 yr | ProductDelisted |
| 12496326 | Sep 29, 2036 | in 10 yr 5 mo | U-3627 |
| 11951153 | Feb 28, 2037 | in 10 yr 10 mo | U-1483 |
| 10918694 | Feb 28, 2037 | in 10 yr 10 mo | Product |
| 10813976 | Sep 22, 2037 | in 11 yr 5 mo | Product |
| 11154513 | Nov 20, 2038 | in 12 yr 7 mo | ProductU-1900 |
| 11413323 | Oct 11, 2039 | in 13 yr 6 mo | U-3627 |
| 12059449 | Apr 01, 2042 | in 16 yr | ProductU-1483 |
Cyclosporine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
