FDA Orange Book · active-ingredient family
Carboplatin
Carboplatin is approved as 3 brand and 34 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:KYXATA · NDA 219921
3
Brand (NDA)
34
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| KYXATARLD×3 | AVYXA HOLDINGS | NDA 219921 | — | Aug 08, 2025 | |
| PARAPLATINRLD×4 | CORDENPHARMA | NDA 020452 | — | Jul 14, 2003 | |
| PARAPLATINRLD×3 | CORDEN PHARMA | NDA 019880 | — | Mar 03, 1989 |
Generic (ANDA) products (34)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CARBOPLATIN×4 | QILU PHARM HAINAN | ANDA 219999 | AP | Feb 04, 2026 | |
| CARBOPLATIN×5 | ACCORD HLTHCARE | ANDA 206775 | — | Apr 06, 2020 | |
| CARBOPLATIN×4 | INGENUS PHARMS LLC | ANDA 208487 | — | Apr 26, 2017 | |
| CARBOPLATIN×4 | GLAND | ANDA 207324 | AP | Feb 15, 2017 | |
| CARBOPLATIN×4 | EUGIA PHARMA | ANDA 205487 | AP | Mar 28, 2016 | |
| CARBOPLATIN×3 | NATCO PHARMA USA | ANDA 091510 | — | May 29, 2012 | |
| CARBOPLATIN×4 | ACTAVIS TOTOWA | ANDA 078732 | — | Feb 06, 2012 | |
| CARBOPLATIN | PHARMOBEDIENT | ANDA 091478 | — | Nov 23, 2011 | |
| CARBOPLATIN×4 | PHARMOBEDIENT | ANDA 091063 | — | Nov 09, 2011 | |
| CARBOPLATIN | EPIC PHARMA LLC | ANDA 091268 | AP | Jul 28, 2010 | |
| CARBOPLATIN×3 | EPIC PHARMA LLC | ANDA 090475 | AP | Jul 29, 2009 | |
| CARBOPLATIN×3 | PHARMACHEMIE BV | ANDA 077679 | — | Feb 25, 2009 | |
| CARBOPLATIN×4 | PLIVA LACHEMA | ANDA 078631 | — | Dec 02, 2008 | |
| CARBOPLATIN×3 | SUN PHARM | ANDA 077926 | AP | Sep 19, 2008 | |
| CARBOPLATIN×3 | SANDOZ | ANDA 078280 | AP | May 08, 2008 | |
| CARBOPLATIN×3 | PHARMOBEDIENT | ANDA 077998 | — | Apr 24, 2007 | |
| CARBOPLATIN×3 | TEVA PARENTERAL | ANDA 077389 | — | Mar 30, 2007 | |
| CARBOPLATIN×4 | TEYRO LABS | ANDA 077861 | AP | Jan 18, 2007 | |
| CARBOPLATIN×3 | FRESENIUS KABI USA | ANDA 077432 | — | Sep 29, 2006 | |
| CARBOPLATIN×4 | FRESENIUS KABI USA | ANDA 077266 | — | Feb 15, 2006 | |
| CARBOPLATIN×3 | CIPLA LTD | ANDA 077383 | — | Jan 27, 2006 | |
| CARBOPLATIN×4 | TEVA PHARMS USA | ANDA 077139 | — | Sep 21, 2005 | |
| CARBOPLATIN×4 | MEITHEAL | ANDA 077096 | — | Jun 14, 2005 | |
| CARBOPLATIN×3 | SANDOZ | ANDA 076959 | — | Mar 18, 2005 | |
| CARBOPLATIN | HOSPIRA | ANDA 077059 | AP | Nov 23, 2004 | |
| CARBOPLATIN×3 | PLIVA | ANDA 076602 | — | Nov 16, 2004 | |
| CARBOPLATIN×3 | HOSPIRA | ANDA 076473 | — | Oct 27, 2004 | |
| CARBOPLATIN×3 | FRESENIUS KABI USA | ANDA 077247 | — | Oct 21, 2004 | |
| CARBOPLATIN×4 | HIKMA | ANDA 077244 | AP | Oct 15, 2004 | |
| CARBOPLATIN×3 | FRESENIUS KABI USA | ANDA 076235 | — | Oct 14, 2004 | |
| CARBOPLATIN×3 | HIKMA | ANDA 076099 | — | Oct 14, 2004 | |
| CARBOPLATIN×3 | WATSON LABS TEVA | ANDA 076162 | — | Oct 14, 2004 | |
| CARBOPLATIN×3 | HOSPIRA | ANDA 076517 | AP | Oct 14, 2004 | |
| CARBOPLATIN×4 | PHARMACHEMIE BV | ANDA 077269 | AP | Oct 14, 2004 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12427104 | Apr 01, 2045 | in 19 yr 1 mo | Product |
Carboplatin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
