Orange Book product · Brand (NDA)
TASIGNA
NILOTINIB HYDROCHLORIDE
At a glance
Oct 29, 2007
Approved
Brand (NDA)
Application
AB
TE code
14
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 29, 2007
18 yr 11 mo ago
Today
Patent 8389537 expires
Listed method-of-use patent (U-1374) expiration.
Jul 18, 2026
in 29 d
Patent 8415363 expires
Listed drug substance patent expiration.
Jul 18, 2026
in 29 d
Patent 8415363 expires
Listed drug substance patent expiration.
Jul 18, 2026
in 29 d
Patent 8501760 expires
Listed drug product patent expiration.
Jul 18, 2026
in 29 d
Patent 8389537*PED expires
Listed listed patent expiration.
Jan 18, 2027
in 7 mo
Patent 8415363*PED expires
Listed listed patent expiration.
Jan 18, 2027
in 7 mo
Patent 8501760*PED expires
Listed listed patent expiration.
Jan 18, 2027
in 7 mo
Patent 8293756 expires
Listed drug product patent expiration.
Sep 25, 2027
in 1 yr 3 mo
Patent 8293756*PED expires
Listed listed patent expiration.
Mar 25, 2028
in 1 yr 10 mo
Patent 8163904 expires
Listed drug substance patent expiration.
Aug 23, 2028
in 2 yr 3 mo
Exclusivity ends · ODE-380
Orphan-drug exclusivity (7 years)
Sep 23, 2028
in 2 yr 4 mo
Patent 8163904*PED expires
Listed listed patent expiration.
Feb 23, 2029
in 2 yr 9 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Mar 23, 2029
in 2 yr 10 mo
Patent 9061029 expires
Listed drug substance patent expiration.
Apr 07, 2032
in 5 yr 11 mo
Patent 9061029 expires
Listed drug substance patent expiration.
Apr 07, 2032
in 5 yr 11 mo
Patent 9061029*PED expires
Listed listed patent expiration.
Oct 07, 2032
in 6 yr 5 mo
Pharmaceutical detail
Active ingredient
NILOTINIB HYDROCHLORIDE
Strength
EQ 200MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 022068
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.
- 2025NILOTINIB HYDROCHLORIDEGeneric (ANDA)
ANDA 218532 · TORRENT
- 2025NILOTINIB HYDROCHLORIDEGeneric (ANDA)
ANDA 218350 · DR REDDYS
- 2025NILOTINIB HYDROCHLORIDEGeneric (ANDA)
ANDA 209651 · HETERO LABS LTD V
- 2025NILOTINIB HYDROCHLORIDEGeneric (ANDA)
ANDA 218544 · MSN
- 2024NILOTINIB HYDROCHLORIDEGeneric (ANDA)
ANDA 203640 · APOTEX
Marketing exclusivity (2)
- ODE-380Orphan-drug exclusivity (7 years)
Sep 23, 2028
in 2 yr 4 mo
- PEDPediatric exclusivity (adds 6 months)
Mar 23, 2029
in 2 yr 10 mo
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8389537 | Jul 18, 2026 | in 29 d | U-1374 |
| 8415363 | Jul 18, 2026 | in 29 d | SubstanceProductU-1407 |
| 8415363 | Jul 18, 2026 | in 29 d | SubstanceProductU-1374 |
| 8501760 | Jul 18, 2026 | in 29 d | Product |
| 8389537*PED | Jan 18, 2027 | in 7 mo | |
| 8415363*PED | Jan 18, 2027 | in 7 mo | |
| 8501760*PED | Jan 18, 2027 | in 7 mo | |
| 8293756 | Sep 25, 2027 | in 1 yr 3 mo | Product |
| 8293756*PED | Mar 25, 2028 | in 1 yr 10 mo | |
| 8163904 | Aug 23, 2028 | in 2 yr 3 mo | SubstanceProduct |
| 8163904*PED | Feb 23, 2029 | in 2 yr 9 mo | |
| 9061029 | Apr 07, 2032 | in 5 yr 11 mo | SubstanceU-1374 |
| 9061029 | Apr 07, 2032 | in 5 yr 11 mo | SubstanceU-3231 |
| 9061029*PED | Oct 07, 2032 | in 6 yr 5 mo |
