Orange Book product · Brand (NDA)
BEIZRAY
DOCETAXEL
At a glance
Oct 23, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
11
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 23, 2024
1 yr 8 mo ago
Today
Patent 11419842 expires
Listed drug product patent expiration.
May 16, 2036
in 10 yr 1 mo
Patent 11419842 expires
Listed drug product patent expiration.
May 16, 2036
in 10 yr 1 mo
Patent 11419842 expires
Listed drug product patent expiration.
May 16, 2036
in 10 yr 1 mo
Patent 11419842 expires
Listed drug product patent expiration.
May 16, 2036
in 10 yr 1 mo
Patent 11419842 expires
Listed drug product patent expiration.
May 16, 2036
in 10 yr 1 mo
Patent 12090134 expires
Listed drug product patent expiration.
May 16, 2036
in 10 yr 1 mo
Patent 12090134 expires
Listed drug product patent expiration.
May 16, 2036
in 10 yr 1 mo
Patent 12090134 expires
Listed drug product patent expiration.
May 16, 2036
in 10 yr 1 mo
Patent 12090134 expires
Listed drug product patent expiration.
May 16, 2036
in 10 yr 1 mo
Patent 12090134 expires
Listed drug product patent expiration.
May 16, 2036
in 10 yr 1 mo
Patent 12090135 expires
Listed drug product patent expiration.
May 16, 2036
in 10 yr 1 mo
Pharmaceutical detail
Active ingredient
DOCETAXEL
Strength
80MG/4ML (20MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 218711
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.
- 2022DOCIVYXBrand (NDA)
NDA 215813 · AVYXA HOLDINGS
- 2015DOCETAXELBrand (NDA)
NDA 205934 · SHILPA
- 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 (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11419842 | May 16, 2036 | in 10 yr 1 mo | ProductU-881 |
| 11419842 | May 16, 2036 | in 10 yr 1 mo | ProductU-937 |
| 11419842 | May 16, 2036 | in 10 yr 1 mo | ProductU-946 |
| 11419842 | May 16, 2036 | in 10 yr 1 mo | ProductU-4027 |
| 11419842 | May 16, 2036 | in 10 yr 1 mo | ProductU-4028 |
| 12090134 | May 16, 2036 | in 10 yr 1 mo | ProductU-881 |
| 12090134 | May 16, 2036 | in 10 yr 1 mo | ProductU-937 |
| 12090134 | May 16, 2036 | in 10 yr 1 mo | ProductU-946 |
| 12090134 | May 16, 2036 | in 10 yr 1 mo | ProductU-4027 |
| 12090134 | May 16, 2036 | in 10 yr 1 mo | ProductU-4028 |
| 12090135 | May 16, 2036 | in 10 yr 1 mo | Product |
