Orange Book product · Brand (NDA)
DOCETAXEL
DOCETAXEL
At a glance
Dec 22, 2015
Approved
Brand (NDA)
Application
AP
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 22, 2015
10 yr 8 mo ago
Today
Patent 10842770 expires
Listed drug product patent expiration.
Aug 07, 2031
in 5 yr 3 mo
Patent 8940786 expires
Listed drug product patent expiration.
Sep 30, 2033
in 7 yr 5 mo
Patent 9308195 expires
Listed drug product patent expiration.
Sep 30, 2033
in 7 yr 5 mo
Patent 9763880 expires
Listed method-of-use patent (U-2563) expiration.
Sep 30, 2033
in 7 yr 5 mo
Patent 9763880 expires
Listed method-of-use patent (U-2559) expiration.
Sep 30, 2033
in 7 yr 5 mo
Patent 9763880 expires
Listed method-of-use patent (U-2558) expiration.
Sep 30, 2033
in 7 yr 5 mo
Patent 9763880 expires
Listed method-of-use patent (U-2562) expiration.
Sep 30, 2033
in 7 yr 5 mo
Patent 9763880 expires
Listed method-of-use patent (U-2564) expiration.
Sep 30, 2033
in 7 yr 5 mo
Patent 9763880 expires
Listed method-of-use patent (U-2561) expiration.
Sep 30, 2033
in 7 yr 5 mo
Patent 9763880 expires
Listed method-of-use patent (U-2560) expiration.
Sep 30, 2033
in 7 yr 5 mo
Pharmaceutical detail
Active ingredient
DOCETAXEL
Strength
160MG/8ML (20MG/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 205934
Product number
003
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.
- 2024BEIZRAYBrand (NDA)
NDA 218711 · ZHUHAI
- 2022DOCIVYXBrand (NDA)
NDA 215813 · AVYXA HOLDINGS
- 2014DOCETAXELBrand (NDA)
NDA 202356 · PFIZER LABS
- 2013DOCETAXELBrand (NDA)
NDA 203551 · ACTAVIS
- 2012DOCETAXELBrand (NDA)
NDA 022312 · APOTEX INC
- 2011DOCETAXELBrand (NDA)
NDA 201525 · SANDOZ
- 2011DOCETAXELBrand (NDA)
NDA 201195 · ACCORD HLTHCARE
- 2011DOCEFREZBrand (NDA)
NDA 022534 · SUN PHARM
- 2011DOCETAXELBrand (NDA)
NDA 022234 · HOSPIRA INC
- 2010TAXOTEREBrand (NDA)
NDA 020449 · SANOFI AVENTIS US
- 2025DOCETAXELGeneric (ANDA)
ANDA 213768 · GUANGDONG SUNHO
- 2024DOCETAXELGeneric (ANDA)
ANDA 216677 · HERITAGE
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10842770 | Aug 07, 2031 | in 5 yr 3 mo | ProductU-2998 |
| 8940786 | Sep 30, 2033 | in 7 yr 5 mo | ProductU-1789 |
| 9308195 | Sep 30, 2033 | in 7 yr 5 mo | Product |
| 9763880 | Sep 30, 2033 | in 7 yr 5 mo | U-2563 |
| 9763880 | Sep 30, 2033 | in 7 yr 5 mo | U-2559 |
| 9763880 | Sep 30, 2033 | in 7 yr 5 mo | U-2558 |
| 9763880 | Sep 30, 2033 | in 7 yr 5 mo | U-2562 |
| 9763880 | Sep 30, 2033 | in 7 yr 5 mo | U-2564 |
| 9763880 | Sep 30, 2033 | in 7 yr 5 mo | U-2561 |
| 9763880 | Sep 30, 2033 | in 7 yr 5 mo | U-2560 |
