Orange Book product · Brand (NDA)
FYARRO
SIROLIMUS
At a glance
Nov 22, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 22, 2021
4 yr 8 mo ago
Today
Exclusivity ends · ODE-386
Orphan-drug exclusivity (7 years)
Nov 22, 2028
in 2 yr 6 mo
Patent 8911786 expires
Listed drug product patent expiration.
Feb 14, 2029
in 2 yr 8 mo
Patent 10206887 expires
Listed drug product patent expiration.
Apr 15, 2030
in 3 yr 11 mo
Patent 10705070 expires
Listed drug product patent expiration.
Mar 05, 2036
in 9 yr 10 mo
Patent 12061183 expires
Listed drug product patent expiration.
Mar 05, 2036
in 9 yr 10 mo
Patent 10973806 expires
Listed method-of-use patent (U-3258) expiration.
Jun 29, 2036
in 10 yr 2 mo
Patent 12133844 expires
Listed method-of-use patent (U-4040) expiration.
Jun 29, 2036
in 10 yr 2 mo
Patent 12133844 expires
Listed method-of-use patent (U-4041) expiration.
Jun 29, 2036
in 10 yr 2 mo
Patent 12133844 expires
Listed method-of-use patent (U-4042) expiration.
Jun 29, 2036
in 10 yr 2 mo
Patent 11497737 expires
Listed drug product patent expiration.
Oct 28, 2040
in 14 yr 7 mo
Pharmaceutical detail
Active ingredient
SIROLIMUS
Strength
100MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 213312
Product number
001
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.
- 2022HYFTORBrand (NDA)
NDA 213478 · NOBELPHARMA
- 2010RAPAMUNEBrand (NDA)
NDA 021110 · PF PRISM CV
- 1999RAPAMUNEBrand (NDA)
NDA 021083 · PF PRISM CV
- 2025SIROLIMUSGeneric (ANDA)
ANDA 215116 · RISING
- 2024SIROLIMUSGeneric (ANDA)
ANDA 215080 · HETERO LABS LTD V
- 2023SIROLIMUSGeneric (ANDA)
ANDA 201676 · ZYDUS PHARMS
- 2023SIROLIMUSGeneric (ANDA)
ANDA 216728 · MSN
- 2021SIROLIMUSGeneric (ANDA)
ANDA 215016 · TORRENT
- 2021SIROLIMUSGeneric (ANDA)
ANDA 214753 · ALKEM LABS LTD
- 2020SIROLIMUSGeneric (ANDA)
ANDA 208691 · GLENMARK PHARMS LTD
- 2019SIROLIMUSGeneric (ANDA)
ANDA 211406 · APOTEX
- 2019SIROLIMUSGeneric (ANDA)
ANDA 211212 · AMNEAL
Marketing exclusivity (1)
- ODE-386Orphan-drug exclusivity (7 years)
Nov 22, 2028
in 2 yr 6 mo
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8911786 | Feb 14, 2029 | in 2 yr 8 mo | ProductU-3259 |
| 10206887 | Apr 15, 2030 | in 3 yr 11 mo | Product |
| 10705070 | Mar 05, 2036 | in 9 yr 10 mo | Product |
| 12061183 | Mar 05, 2036 | in 9 yr 10 mo | Product |
| 10973806 | Jun 29, 2036 | in 10 yr 2 mo | U-3258 |
| 12133844 | Jun 29, 2036 | in 10 yr 2 mo | U-4040 |
| 12133844 | Jun 29, 2036 | in 10 yr 2 mo | U-4041 |
| 12133844 | Jun 29, 2036 | in 10 yr 2 mo | U-4042 |
| 11497737 | Oct 28, 2040 | in 14 yr 7 mo | Product |
