FDA Orange Book · active-ingredient family
Docetaxel
Docetaxel: 11 brands, 20 generics; first approved May 14, 1996; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 20 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
11
Generics (ANDA)
20
Listed patents
8
Next patent expiry
Aug 07, 2031
in 5 yr
Brand (NDA) products
Originator applications
- ZHUHAINDA 2187112024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG/4ML (20MG/ML) SOLUTION INTRAVENOUS Rx — - AVYXA HOLDINGSNDA 21581320223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/2ML (10MG/ML) SOLUTION INTRAVENOUS Rx — 80MG/8ML (10MG/ML) SOLUTION INTRAVENOUS Rx — 160MG/16ML (10MG/ML) SOLUTION INTRAVENOUS Rx — - DOCETAXELRLDRSSHILPANDA 20593420153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML (20MG/ML) INJECTABLE INJECTION Rx AP 80MG/4ML (20MG/ML) INJECTABLE INJECTION Rx AP 160MG/8ML (20MG/ML) INJECTABLE INJECTION Rx AP - DOCETAXELRLDACCORD HLTHCARENDA 20119520115 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/0.5ML (40MG/ML) INJECTABLE INJECTION Discontinued — 80MG/2ML (40MG/ML) INJECTABLE INJECTION Discontinued — 20MG/ML (20MG/ML) INJECTABLE INJECTION Rx AP 80MG/4ML (20MG/ML) INJECTABLE INJECTION Rx AP 160MG/8ML (20MG/ML) INJECTABLE INJECTION Rx AP - DOCEFREZRLDSUN PHARMNDA 02253420115 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/VIAL INJECTABLE INJECTION Discontinued — 80MG/VIAL INJECTABLE INJECTION Discontinued — 20MG/ML (20MG/ML) INJECTABLE INJECTION Discontinued — 80MG/4ML (20MG/ML) INJECTABLE INJECTION Discontinued — 160MG/8ML (20MG/ML) INJECTABLE INJECTION Discontinued — - DOCETAXELRLDRSHOSPIRA INCNDA 02223420117 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/2ML (10MG/ML) INJECTABLE INJECTION Rx AP 80MG/8ML (10MG/ML) INJECTABLE INJECTION Rx AP 160MG/16ML (10MG/ML) INJECTABLE INJECTION Rx AP 20MG/ML (20MG/ML) INJECTABLE INJECTION Rx — 80MG/4ML (20MG/ML) INJECTABLE INJECTION Rx — 120MG/6ML (20MG/ML) INJECTABLE INJECTION Discontinued — 160MG/8ML (20MG/ML) INJECTABLE INJECTION Rx — - TAXOTERERLDSANOFI AVENTIS USNDA 02044920104 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE INJECTION Discontinued — 20MG/ML (20MG/ML) INJECTABLE INJECTION Discontinued — 80MG/4ML (20MG/ML) INJECTABLE INJECTION Discontinued — 160MG/8ML (20MG/ML) INJECTABLE INJECTION Rx AP - DOCETAXELPFIZER LABSNDA 20235620144 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/2ML (10MG/ML) INJECTABLE INJECTION Discontinued — 80MG/8ML (10MG/ML) INJECTABLE INJECTION Discontinued — 130MG/13ML (10MG/ML) INJECTABLE INJECTION Discontinued — 200MG/20ML (10MG/ML) INJECTABLE INJECTION Discontinued — - DOCETAXELACTAVISNDA 20355120134 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML (20MG/ML) INJECTABLE INJECTION Rx AP 80MG/4ML (20MG/ML) INJECTABLE INJECTION Rx AP 140MG/7ML (20MG/ML) INJECTABLE INJECTION Rx — 160MG/8ML (20MG/ML) INJECTABLE INJECTION Rx AP - DOCETAXELAPOTEX INCNDA 02231220122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/0.5ML (40MG/ML) INJECTABLE INJECTION Discontinued — 80MG/2ML (40MG/ML) INJECTABLE INJECTION Discontinued — - DOCETAXELSANDOZNDA 20152520113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/2ML (10MG/ML) INJECTABLE INJECTION Rx AP 80MG/8ML (10MG/ML) INJECTABLE INJECTION Rx AP 160MG/16ML (10MG/ML) INJECTABLE INJECTION Rx AP
Generic (ANDA) products (20)
Abbreviated applications
- DOCETAXELGUANGDONG SUNHOANDA 21376820252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML (20MG/ML) INJECTABLE INJECTION Rx AP 80MG/4ML (20MG/ML) INJECTABLE INJECTION Rx AP - DOCETAXELHERITAGEANDA 21667720243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML (20MG/ML) INJECTABLE INJECTION Rx AP 80MG/4ML (20MG/ML) INJECTABLE INJECTION Rx AP 160MG/8ML (20MG/ML) INJECTABLE INJECTION Rx AP - DOCETAXELPHARMOBEDIENTANDA 20389220232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML (20MG/ML) INJECTABLE INJECTION Discontinued — 80MG/4ML (20MG/ML) INJECTABLE INJECTION Discontinued — - DOCETAXELALEMBICANDA 21574420233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/2ML (10MG/ML) INJECTABLE INJECTION Rx AP 80MG/8ML (10MG/ML) INJECTABLE INJECTION Rx AP 160MG/16ML (10MG/ML) INJECTABLE INJECTION Rx AP - DOCETAXELGLANDANDA 21351020213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/2ML (10MG/ML) INJECTABLE INJECTION Rx AP 80MG/8ML (10MG/ML) INJECTABLE INJECTION Rx AP 160MG/16ML (10MG/ML) INJECTABLE INJECTION Rx AP - DOCETAXELEUGIA PHARMAANDA 21457520213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/2ML (10MG/ML) INJECTABLE INJECTION Discontinued — 80MG/8ML (10MG/ML) INJECTABLE INJECTION Discontinued — 160MG/16ML (10MG/ML) INJECTABLE INJECTION Discontinued — - DOCETAXELHIKMAANDA 20449020212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML (20MG/ML) INJECTABLE INJECTION Rx AP 80MG/4ML (20MG/ML) INJECTABLE INJECTION Rx AP - DOCETAXELSHILPAANDA 21032720193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML (20MG/ML) INJECTABLE INJECTION Rx AP 80MG/4ML (20MG/ML) INJECTABLE INJECTION Rx AP 160MG/8ML (20MG/ML) INJECTABLE INJECTION Rx AP - DOCETAXELMYLAN LABS LTDANDA 2081372019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 160MG/8ML (20MG/ML) INJECTABLE INJECTION Rx AP - DOCETAXELMEITHEALANDA 20963420183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/2ML (10MG/ML) INJECTABLE INJECTION Rx AP 80MG/8ML (10MG/ML) INJECTABLE INJECTION Rx AP 160MG/16ML (10MG/ML) INJECTABLE INJECTION Rx AP - DOCETAXELMYLAN LABS LTDANDA 2108482018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG/8ML (10MG/ML) INJECTABLE INJECTION Rx AP - DOCETAXELMYLAN LABS LTDANDA 2100722018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/2ML (10MG/ML) INJECTABLE INJECTION Rx AP - DOCETAXELMYLAN LABS LTDANDA 2088592018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 160MG/16ML (10MG/ML) INJECTABLE INJECTION Rx AP - DOCETAXELRSAMNEALANDA 20964020183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML (20MG/ML) INJECTABLE INJECTION Rx AP 80MG/4ML (20MG/ML) INJECTABLE INJECTION Rx AP 160MG/8ML (20MG/ML) INJECTABLE INJECTION Rx AP - DOCETAXELINGENUS PHARMS LLCANDA 20756320173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/2ML (10MG/ML) INJECTABLE INJECTION Discontinued — 80MG/8ML (10MG/ML) INJECTABLE INJECTION Discontinued — 160MG/16ML (10MG/ML) INJECTABLE INJECTION Discontinued — - DOCETAXELHENGRUI PHARMAANDA 20725220173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML (20MG/ML) INJECTABLE INJECTION Rx AP 80MG/4ML (20MG/ML) INJECTABLE INJECTION Rx AP 160MG/8ML (20MG/ML) INJECTABLE INJECTION Rx AP - DOCETAXELHENGRUI PHARMAANDA 2031702017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/ML INJECTABLE INJECTION Discontinued — - DOCETAXELDFB ONCOLOGY LTDANDA 20617720173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML (20MG/ML) INJECTABLE INJECTION Discontinued — 80MG/4ML (20MG/ML) INJECTABLE INJECTION Discontinued — 200MG/10ML (20MG/ML) INJECTABLE INJECTION Discontinued — - DOCETAXELTEVA PHARMS USAANDA 20387720152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML (20MG/ML) INJECTABLE INJECTION Discontinued — 80MG/4ML (20MG/ML) INJECTABLE INJECTION Discontinued — - DOCETAXELDR REDDYSANDA 20419320142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML (20MG/ML) INJECTABLE INJECTION Rx AP 80MG/4ML (20MG/ML) INJECTABLE INJECTION Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 10842770 | in 5 yr | ProductU-2998 | |
| 9763880 | in 7 yr 2 mo | U-2560 | |
| 8940786 | in 7 yr 2 mo | ProductU-1789 | |
| 9308195 | in 7 yr 2 mo | Product | |
| 10398785 | in 9 yr 8 mo | Product | |
| 11419842 | in 9 yr 10 mo | ProductU-881 | |
| 12090134 | in 9 yr 10 mo | ProductU-881 | |
| 12090135 | in 9 yr 10 mo | Product |
Approval history
FDA approval span
First approval
30 yr 9 mo ago
Most recent approval
1 yr 4 mo ago
Approvals span 1996–2025 across 31 FDA applications.
Brand (NDA) 1135%
Generic (ANDA) 2065%
Docetaxel: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
