FDA Orange Book · active-ingredient family
Daptomycin
Daptomycin is approved as 7 brand and 25 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DAPTOMYCIN · NDA 217630
7
Brand (NDA)
25
Generics (ANDA)
8
Listed patents
0
Exclusivity periods
Brand (NDA) products · powder, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DAPTOMYCINRLD×2 | MAIA PHARMS INC | NDA 217630 | — | Nov 21, 2024 | |
| DAPTOMYCINRLD×2 | HIKMA | NDA 217415 | — | Jan 30, 2023 | |
| DAPZURA RTRLD×5 | BAXTER HLTHCARE CORP | NDA 213645 | — | Jan 25, 2022 | |
| DAPTOMYCINRLD×2 | HOSPIRA | NDA 210282 | — | Jun 21, 2021 | |
| DAPTOMYCINRLD | HIKMA | NDA 209949 | — | Oct 20, 2017 | |
| DAPTOMYCINRLD | SAGENT PHARMS INC | NDA 208385 | AP | Sep 12, 2017 | |
| CUBICINRLD×3 | CUBIST PHARMS LLC | NDA 021572 | — | Sep 12, 2003 |
Generic (ANDA) products (25)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DAPTOMYCIN | BIOCON PHARMA | ANDA 217215 | AP | Aug 29, 2024 | |
| DAPTOMYCIN | FRESENIUS KABI USA | ANDA 213396 | — | Aug 01, 2024 | |
| DAPTOMYCIN | MYLAN | ANDA 213966 | AP | Aug 07, 2023 | |
| DAPTOMYCIN | ASPIRO | ANDA 216445 | AP | Dec 23, 2022 | |
| DAPTOMYCIN | ASPIRO | ANDA 216413 | AP | Sep 23, 2022 | |
| DAPTOMYCIN | HAINAN POLY PHARM | ANDA 215890 | AP | Aug 18, 2022 | |
| DAPTOMYCIN | HANGZHOU ZHONGMEI | ANDA 215215 | — | Nov 26, 2021 | |
| DAPTOMYCIN | EUGIA PHARMA | ANDA 213171 | AP | Sep 02, 2021 | |
| DAPTOMYCIN | QILU PHARM HAINAN | ANDA 215316 | AP | Aug 24, 2021 | |
| DAPTOMYCIN | MEITHEAL | ANDA 213786 | AP | Jun 29, 2021 | |
| DAPTOMYCIN | MEITHEAL | ANDA 213623 | AP | Jun 29, 2021 | |
| DAPTOMYCIN | HISUN PHARM HANGZHOU | ANDA 212250 | AP | Apr 21, 2021 | |
| DAPTOMYCIN | DR REDDYS | ANDA 211403 | AP | Aug 31, 2020 | |
| DAPTOMYCIN | BE PHARMS | ANDA 213425 | AP | Aug 20, 2020 | |
| DAPTOMYCIN | SAGENT PHARMS INC | ANDA 207104 | AP | Nov 15, 2019 | |
| DAPTOMYCIN | HENGRUI PHARMA | ANDA 212022 | — | Aug 22, 2019 | |
| DAPTOMYCIN | ACCORD HLTHCARE | ANDA 212667 | AP | Jul 12, 2019 | |
| DAPTOMYCIN | BE PHARMS | ANDA 212513 | AP | Jun 26, 2019 | |
| DAPTOMYCIN | ACCORD HLTHCARE | ANDA 211961 | AP | Jun 24, 2019 | |
| DAPTOMYCIN | DR REDDYS | ANDA 208375 | AP | May 01, 2019 | |
| DAPTOMYCIN | MYLAN LABS LTD | ANDA 205037 | AP | Jun 05, 2018 | |
| DAPTOMYCIN | FRESENIUS KABI USA | ANDA 206077 | AP | Apr 11, 2018 | |
| DAPTOMYCIN | XELLIA PHARMS APS | ANDA 206005 | AP | Jun 15, 2016 | |
| DAPTOMYCIN | TEVA PHARMS USA | ANDA 091039 | AP | Mar 25, 2016 | |
| DAPTOMYCIN | HOSPIRA | ANDA 202857 | — | Sep 12, 2014 |
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8003673 | Sep 04, 2028 | in 2 yr 3 mo | U-1180 |
| 9138456 | Nov 23, 2030 | in 4 yr 6 mo | Product |
| 10357535 | Sep 11, 2033 | in 7 yr 4 mo | ProductU-3176 |
| 9655946 | Sep 11, 2033 | in 7 yr 4 mo | ProductU-3175 |
| 12053502 | Aug 28, 2038 | in 12 yr 4 mo | U-3981 |
| 11759497 | Aug 28, 2038 | in 12 yr 4 mo | Product |
| 11173189 | Mar 11, 2041 | in 14 yr 11 mo | ProductU-3294 |
| 12629337 | Jan 09, 2043 | in 16 yr 10 mo | Product |
Daptomycin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
