Orange Book product · Brand (NDA)
ABRAXANE
PACLITAXEL
At a glance
Jan 07, 2005
Approved
Brand (NDA)
Application
AB
TE code
14
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 07, 2005
21 yr 9 mo ago
Patent 7758891 expires
Listed method-of-use patent (U-1434) expiration.
Feb 21, 2026
4 mo ago
Patent 8268348 expires
Listed method-of-use patent (U-1290) expiration.
Feb 21, 2026
4 mo ago
Patent 9101543 expires
Listed method-of-use patent (U-1434) expiration.
Feb 21, 2026
4 mo ago
Today
Patent 8034375 expires
Listed method-of-use patent (U-1290) expiration.
Aug 13, 2026
in 2 mo
Patent 7758891*PED expires
Listed listed patent expiration.
Aug 21, 2026
in 2 mo
Patent 8268348*PED expires
Listed listed patent expiration.
Aug 21, 2026
in 2 mo
Patent 9101543*PED expires
Listed listed patent expiration.
Aug 21, 2026
in 2 mo
Patent 8034375*PED expires
Listed listed patent expiration.
Feb 13, 2027
in 8 mo
Patent 9393318 expires
Listed method-of-use patent (U-1290) expiration.
Mar 04, 2032
in 5 yr 10 mo
Patent 9597409 expires
Listed method-of-use patent (U-1290) expiration.
Mar 04, 2032
in 5 yr 10 mo
Patent 9393318*PED expires
Listed listed patent expiration.
Sep 04, 2032
in 6 yr 4 mo
Patent 9597409*PED expires
Listed listed patent expiration.
Sep 04, 2032
in 6 yr 4 mo
Patent 9511046 expires
Listed method-of-use patent (U-1434) expiration.
Jan 12, 2034
in 7 yr 8 mo
Patent 9511046*PED expires
Listed listed patent expiration.
Jul 12, 2034
in 8 yr 2 mo
Pharmaceutical detail
Active ingredient
PACLITAXEL
Strength
100MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
AB
Application
NDA 021660
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.
- 2023PACLITAXELBrand (NDA)
NDA 216338 · TEVA PHARMS INC
- 2022PACLITAXELBrand (NDA)
NDA 211875 · AM REGENT
- 1992TAXOLBrand (NDA)
NDA 020262 · HQ SPCLT PHARMA
- 2025PACLITAXELGeneric (ANDA)
ANDA 217877 · MYLAN
- 2025PACLITAXELGeneric (ANDA)
ANDA 216355 · SHUANGCHENG
- 2025PACLITAXELGeneric (ANDA)
ANDA 209657 · CIPLA
- 2024PACLITAXELGeneric (ANDA)
ANDA 212700 · HENGRUI PHARMA
- 2022PACLITAXELGeneric (ANDA)
ANDA 216874 · ALEMBIC
- 2020PACLITAXELGeneric (ANDA)
ANDA 213434 · MSN
- 2018PACLITAXELGeneric (ANDA)
ANDA 205720 · ACCORD HLTHCARE
- 2016PACLITAXELGeneric (ANDA)
ANDA 207326 · GLAND
- 2011PACLITAXELGeneric (ANDA)
ANDA 091540 · NATCO PHARMA USA
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7758891 | Feb 21, 2026 | 4 mo ago | U-1434 |
| 8268348 | Feb 21, 2026 | 4 mo ago | U-1290 |
| 9101543 | Feb 21, 2026 | 4 mo ago | U-1434 |
| 8034375 | Aug 13, 2026 | in 2 mo | U-1290 |
| 7758891*PED | Aug 21, 2026 | in 2 mo | |
| 8268348*PED | Aug 21, 2026 | in 2 mo | |
| 9101543*PED | Aug 21, 2026 | in 2 mo | |
| 8034375*PED | Feb 13, 2027 | in 8 mo | |
| 9393318 | Mar 04, 2032 | in 5 yr 10 mo | U-1290 |
| 9597409 | Mar 04, 2032 | in 5 yr 10 mo | U-1290 |
| 9393318*PED | Sep 04, 2032 | in 6 yr 4 mo | |
| 9597409*PED | Sep 04, 2032 | in 6 yr 4 mo | |
| 9511046 | Jan 12, 2034 | in 7 yr 8 mo | U-1434 |
| 9511046*PED | Jul 12, 2034 | in 8 yr 2 mo |
