FDA Orange Book · active-ingredient family
Paclitaxel
Paclitaxel is approved as 4 brand and 20 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PACLITAXEL · NDA 216338
4
Brand (NDA)
20
Generics (ANDA)
14
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PACLITAXELRLD | TEVA PHARMS INC | NDA 216338 | AB | May 11, 2023 | |
| PACLITAXELRLD | AM REGENT | NDA 211875 | AB | Jul 27, 2022 | |
| ABRAXANERLD | BRISTOL-MYERS | NDA 021660 | AB | Jan 07, 2005 | |
| TAXOLRLD | HQ SPCLT PHARMA | NDA 020262 | — | Dec 29, 1992 |
Generic (ANDA) products (20)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PACLITAXEL | MYLAN | ANDA 217877 | AB | Aug 19, 2025 | |
| PACLITAXEL | SHUANGCHENG | ANDA 216355 | AB | May 15, 2025 | |
| PACLITAXEL | CIPLA | ANDA 209657 | AB | Apr 10, 2025 | |
| PACLITAXEL | HENGRUI PHARMA | ANDA 212700 | AB | Oct 08, 2024 | |
| PACLITAXEL | ALEMBIC | ANDA 216874 | AP | Oct 20, 2022 | |
| PACLITAXEL | MSN | ANDA 213434 | AP | Aug 24, 2020 | |
| PACLITAXEL | ACCORD HLTHCARE | ANDA 205720 | AP | Aug 17, 2018 | |
| PACLITAXEL | GLAND | ANDA 207326 | AP | Aug 23, 2016 | |
| PACLITAXEL | NATCO PHARMA USA | ANDA 091540 | — | Sep 29, 2011 | |
| PACLITAXEL | ACTAVIS TOTOWA | ANDA 090130 | AP | Dec 09, 2009 | |
| PACLITAXEL | PLIVA LACHEMA | ANDA 077413 | — | Mar 12, 2008 | |
| PACLITAXEL | SANDOZ | ANDA 078167 | — | Dec 26, 2007 | |
| PACLITAXEL | FRESENIUS KABI USA | ANDA 077574 | AP | Nov 27, 2006 | |
| PACLITAXEL | ACCORD HLTHCARE | ANDA 075436 | — | Nov 12, 2004 | |
| PACLITAXEL | HOSPIRA | ANDA 076233 | — | Aug 01, 2002 | |
| PACLITAXEL | HOSPIRA | ANDA 076131 | AP | May 08, 2002 | |
| PACLITAXEL | HIKMA | ANDA 075190 | AP | Jan 28, 2002 | |
| PACLITAXEL | PHARMOBEDIENT | ANDA 075278 | — | Jan 25, 2002 | |
| PACLITAXEL | TEVA PHARMS | ANDA 075184 | AP | Jan 25, 2002 | |
| PACLITAXEL | TEVA PHARMS USA | ANDA 075297 | — | Jan 25, 2002 |
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8268348 | Feb 21, 2026 | 4 mo ago | U-1290 |
| 9101543 | Feb 21, 2026 | 4 mo ago | U-1434 |
| 7758891 | Feb 21, 2026 | 4 mo ago | U-1434 |
| 8034375 | Aug 13, 2026 | in 2 mo | U-1290 |
| 8268348*PED | Aug 21, 2026 | in 2 mo | |
| 7758891*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 |
Paclitaxel — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
