FDA Orange Book · active-ingredient family
Oxaliplatin
Oxaliplatin is approved as 3 brand and 28 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:OXALIPLATIN · NDA 022160
3
Brand (NDA)
28
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OXALIPLATINRLD×2 | TEVA PHARMS | NDA 022160 | — | Aug 07, 2009 | |
| ELOXATINRLD×3 | SANOFI AVENTIS US | NDA 021759 | — | Jan 31, 2005 | |
| ELOXATINRLD×2 | SANOFI AVENTIS US | NDA 021492 | — | Aug 09, 2002 |
Generic (ANDA) products (28)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OXALIPLATIN×2 | SHANDONG | ANDA 219765 | AP | Jan 15, 2026 | |
| OXALIPLATIN×2 | HETERO LABS LTD VI | ANDA 217925 | AP | Jan 27, 2025 | |
| OXALIPLATIN×2 | MEITHEAL | ANDA 217348 | AP | Jan 11, 2024 | |
| OXALIPLATIN×2 | INGENUS PHARMS LLC | ANDA 207562 | — | Oct 16, 2018 | |
| OXALIPLATIN×2 | ACTAVIS | ANDA 204880 | — | Mar 05, 2018 | |
| OXALIPLATIN×2 | EUGIA PHARMA | ANDA 205529 | — | Sep 06, 2017 | |
| OXALIPLATIN×2 | GLAND | ANDA 207385 | AP | May 23, 2017 | |
| OXALIPLATIN×2 | AM REGENT | ANDA 204378 | — | May 12, 2017 | |
| OXALIPLATIN×3 | ACCORD HLTHCARE | ANDA 207474 | AP | Mar 21, 2017 | |
| OXALIPLATIN×2 | CHARTWELL MOLECULAR | ANDA 208523 | — | Feb 10, 2017 | |
| OXALIPLATIN×3 | GLAND | ANDA 207325 | AP | Feb 10, 2017 | |
| OXALIPLATIN×3 | FRESENIUS KABI USA | ANDA 090030 | — | Jan 31, 2017 | |
| OXALIPLATIN×3 | QILU PHARM HAINAN | ANDA 204368 | AP | Jun 07, 2016 | |
| OXALIPLATIN×2 | QILU PHARM HAINAN | ANDA 204616 | AP | May 11, 2016 | |
| OXALIPLATIN×2 | HENGRUI PHARMA | ANDA 203869 | — | Jun 18, 2014 | |
| OXALIPLATIN×3 | SUN PHARM | ANDA 202922 | — | Apr 08, 2014 | |
| OXALIPLATIN×2 | ACTAVIS TOTOWA | ANDA 078803 | — | Aug 08, 2012 | |
| OXALIPLATIN×2 | PHARMOBEDIENT | ANDA 200979 | — | Aug 08, 2012 | |
| OXALIPLATIN×3 | MYLAN LABS LTD | ANDA 091358 | AP | Aug 07, 2012 | |
| OXALIPLATIN×2 | SANDOZ | ANDA 090849 | — | Apr 28, 2011 | |
| OXALIPLATIN×2 | SANDOZ | ANDA 078817 | AP | Jan 24, 2011 | |
| OXALIPLATIN×2 | FRESENIUS KABI USA | ANDA 078811 | AP | Jun 10, 2010 | |
| OXALIPLATIN×2 | FRESENIUS KABI USA | ANDA 078819 | AP | Jun 02, 2010 | |
| OXALIPLATIN×2 | HOSPIRA INC | ANDA 078815 | — | Sep 30, 2009 | |
| OXALIPLATIN×2 | FRESENIUS KABI ONCOL | ANDA 078810 | — | Aug 07, 2009 | |
| OXALIPLATIN×2 | HOSPIRA WORLDWIDE | ANDA 078813 | AP | Aug 07, 2009 | |
| OXALIPLATIN×2 | SANDOZ | ANDA 078812 | — | Aug 07, 2009 | |
| OXALIPLATIN×2 | SUN PHARM | ANDA 078818 | — | Aug 07, 2009 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Oxaliplatin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
