For right-sided infective endocarditis. Sold as Cubicin, Cubicin Rf, Daptomycin, Dapzura Rt, Daptomycin In 0.9% Sodium Chloride. Every FDA application for this active ingredient: 8 branded and 25 generic.
As of Nov 13, 2026, FDA lists 33 applications for Daptomycin (sold as Cubicin, Cubicin Rf, Daptomycin and others), first approved Sep 12, 2003, with 7 new uses approved and 2 published complete response letters.
| Product | Part | Spending, 2024 | Change | Beneficiaries |
|---|---|---|---|---|
| Daptomycin | Part D | $121M | -9% | 35,354 |
| Cubicin | Part B | $1.9M | -16% | 3,510 |
| Daptomycin (J0872) | Part B | $1.0M | New | 475 |
| Daptomycin (J0877) | Part B | $179K | +166992% | 412 |
| Daptomycin (J0873) | Part B | $29K | New | 114 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Sep 12, 2003 | Cubicin, Cubicin RfNDA 21572 · New molecular entity | Cubist Pharms LLC | 47 | Discontinued |
| Sep 12, 2014 | DaptomycinANDA 202857 | Hospira | 6 | Discontinued |
| Mar 25, 2016 | DaptomycinANDA 91039 | Teva Pharms USA | 4 | Marketed |
| Jun 15, 2016 | DaptomycinANDA 206005 | Xellia Pharms Aps | 6 | Marketed |
| Sep 12, 2017 | DaptomycinNDA 208385 · New formulation or manufacturer | Sagent Pharms Inc | 5 | Marketed |
| Oct 20, 2017 | DaptomycinNDA 209949 · New formulation or manufacturer | Hikma | 5 | Marketed |
| Apr 11, 2018 | DaptomycinANDA 206077 | Fresenius Kabi USA | 4 | Marketed |
| Jun 5, 2018 | DaptomycinANDA 205037 | Mylan Labs Ltd | 4 | Marketed |
| May 1, 2019 | DaptomycinANDA 208375 | Dr Reddys | 0 | Marketed |
| Jun 24, 2019 | DaptomycinANDA 211961 | Accord Hlthcare | 0 | Marketed |
| Jun 26, 2019 | DaptomycinANDA 212513 | Be Pharms | 3 | Marketed |
| Jul 12, 2019 | DaptomycinANDA 212667 | Accord Hlthcare | 1 | Marketed |
| Aug 22, 2019 | DaptomycinANDA 212022 | Hengrui Pharma | 0 | Discontinued |
| Nov 15, 2019 | DaptomycinANDA 207104 | Sagent Pharms Inc | 4 | Marketed |
| Aug 20, 2020 | DaptomycinANDA 213425 | Be Pharms | 1 | Marketed |
| Aug 31, 2020 | DaptomycinANDA 211403 | Dr Reddys | 0 | Marketed |
| Apr 21, 2021 | DaptomycinANDA 212250 | Hisun Pharm Hangzhou | 0 | Marketed |
| Jun 21, 2021 | DaptomycinNDA 210282 · New formulation or manufacturer | Hospira | 2 | Marketed |
| Jun 29, 2021 | DaptomycinANDA 213623 | Meitheal | 3 | Marketed |
| Jun 29, 2021 | DaptomycinANDA 213786 | Meitheal | 2 | Marketed |
| Aug 24, 2021 | DaptomycinANDA 215316 | Qilu Pharm Hainan | 2 | Marketed |
| Sep 2, 2021 | DaptomycinANDA 213171 | Eugia Pharma | 2 | Marketed |
| Nov 26, 2021 | DaptomycinANDA 215215 | Hangzhou Zhongmei | 1 | Discontinued |
| Jan 25, 2022 | Dapzura Rt, Daptomycin In 0.9% Sodium ChlorideNDA 213645 · New formulation or manufacturer | Baxter Hlthcare Corp | 3 | Marketed |
| Aug 18, 2022 | DaptomycinANDA 215890 | Hainan Poly Pharm | 0 | Marketed |
| Sep 23, 2022 | DaptomycinANDA 216413 | Aspiro | 0 | Marketed |
| Dec 23, 2022 | DaptomycinANDA 216445 | Aspiro | 1 | Marketed |
| Jan 30, 2023 | DaptomycinNDA 217415 · New formulation or manufacturer | Hikma | 2 | Marketed |
| Aug 7, 2023 | DaptomycinANDA 213966 | Mylan | 0 | Marketed |
| Aug 1, 2024 | DaptomycinANDA 213396 | Fresenius Kabi USA | 1 | Discontinued |
| Aug 29, 2024 | DaptomycinANDA 217215 | Biocon Pharma | 0 | Marketed |
| Nov 21, 2024 | DaptomycinNDA 217630 · New formulation or manufacturer | Maia Pharms Inc | 0 | Marketed |
| — | DaptomycinNDA 203797 | Hospira Inc | 0 | Discontinued |
| Letter | Product | Now |
|---|---|---|
| Apr 29, 2021 | DAPZURA RT (daptomycin)Non-Clinical | Approved |
| Mar 19, 2018 | DaptomycinFacility Inspections, Product Quality | Approved |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number. Drugs@FDA
