Orange Book product · Brand (NDA)
ENVARSUS XR
TACROLIMUS
At a glance
Jul 10, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
15
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 10, 2015
11 yr 1 mo ago
Today
Patent 10166190 expires
Listed drug product patent expiration.
May 30, 2028
in 2 yr
Patent 10864199 expires
Listed method-of-use patent (U-2678) expiration.
May 30, 2028
in 2 yr
Patent 10864199 expires
Listed method-of-use patent (U-2677) expiration.
May 30, 2028
in 2 yr
Patent 11110081 expires
Listed method-of-use patent (U-2678) expiration.
May 30, 2028
in 2 yr
Patent 11123331 expires
Listed method-of-use patent (U-2677) expiration.
May 30, 2028
in 2 yr
Patent 11419823 expires
Listed drug product patent expiration.
May 30, 2028
in 2 yr
Patent 12083103 expires
Listed method-of-use patent (U-2678) expiration.
May 30, 2028
in 2 yr
Patent 12403095 expires
Listed drug product patent expiration.
May 30, 2028
in 2 yr
Patent 9549918 expires
Listed drug product patent expiration.
May 30, 2028
in 2 yr
Patent 8664239 expires
Listed method-of-use patent (U-1752) expiration.
Aug 30, 2028
in 2 yr 3 mo
Patent 8664239 expires
Listed method-of-use patent (U-2677) expiration.
Aug 30, 2028
in 2 yr 3 mo
Patent 8664239 expires
Listed method-of-use patent (U-2678) expiration.
Aug 30, 2028
in 2 yr 3 mo
Patent 8685998 expires
Listed drug product patent expiration.
Aug 30, 2028
in 2 yr 3 mo
Patent 8685998 expires
Listed drug product patent expiration.
Aug 30, 2028
in 2 yr 3 mo
Patent 8685998 expires
Listed drug product patent expiration.
Aug 30, 2028
in 2 yr 3 mo
Pharmaceutical detail
Active ingredient
TACROLIMUS
Strength
EQ 0.75MG BASE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 206406
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2018PROGRAFBrand (NDA)
NDA 210115 · ASTELLAS
- 2013ASTAGRAF XLBrand (NDA)
NDA 204096 · ASTELLAS
- 2000PROTOPICBrand (NDA)
NDA 050777 · LEO PHARMA AS
- 1998PROGRAFBrand (NDA)
NDA 050708 · ASTELLAS
- 1994PROGRAFBrand (NDA)
NDA 050709 · ASTELLAS
- 2025TACROLIMUSGeneric (ANDA)
ANDA 217108 · NEXUS
- 2024TACROLIMUSGeneric (ANDA)
ANDA 215012 · CHENGDU
- 2023TACROLIMUSGeneric (ANDA)
ANDA 212387 · ENCUBE
- 2023TACROLIMUSGeneric (ANDA)
ANDA 210393 · GLENMARK PHARMS LTD
- 2023TACROLIMUSGeneric (ANDA)
ANDA 210929 · HANGZHOU ZHONGMEI
- 2020TACROLIMUSGeneric (ANDA)
ANDA 203740 · ALKEM LABS LTD
- 2020TACROLIMUSGeneric (ANDA)
ANDA 212297 · BIOCON PHARMA
Listed patents (15)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10166190 | May 30, 2028 | in 2 yr | Product |
| 10864199 | May 30, 2028 | in 2 yr | U-2678 |
| 10864199 | May 30, 2028 | in 2 yr | U-2677 |
| 11110081 | May 30, 2028 | in 2 yr | U-2678 |
| 11123331 | May 30, 2028 | in 2 yr | U-2677 |
| 11419823 | May 30, 2028 | in 2 yr | Product |
| 12083103 | May 30, 2028 | in 2 yr | U-2678 |
| 12403095 | May 30, 2028 | in 2 yr | Product |
| 9549918 | May 30, 2028 | in 2 yr | Product |
| 8664239 | Aug 30, 2028 | in 2 yr 3 mo | U-1752 |
| 8664239 | Aug 30, 2028 | in 2 yr 3 mo | U-2677 |
| 8664239 | Aug 30, 2028 | in 2 yr 3 mo | U-2678 |
| 8685998 | Aug 30, 2028 | in 2 yr 3 mo | ProductU-1752 |
| 8685998 | Aug 30, 2028 | in 2 yr 3 mo | ProductU-2678 |
| 8685998 | Aug 30, 2028 | in 2 yr 3 mo | ProductU-2677 |
