FDA Orange Book
Generic for Dapzura Rt
Dapzura Rt contains daptomycin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Dapzura Rt is daptomycin. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Dapzura Rt products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | 500MG/VIAL | Discontinued | None | 16 | AP |
NDA 213645, held by BAXTER HEALTHCARE CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic daptomycin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 091039 | AP (A-rated, therapeutically equivalent) | March 25, 2016 | 500MG/VIAL |
| XELLIA PHARMACEUTICALS APS | 206005 | AP (A-rated, therapeutically equivalent) | June 15, 2016 | 500MG/VIAL |
| FRESENIUS KABI USA LLC | 206077 | AP (A-rated, therapeutically equivalent) | April 11, 2018 | 500MG/VIAL |
| MYLAN LABORATORIES LTD | 205037 | AP (A-rated, therapeutically equivalent) | June 5, 2018 | 500MG/VIAL |
| DR REDDYS LABORATORIES LTD | 208375 | AP (A-rated, therapeutically equivalent) | May 1, 2019 | 500MG/VIAL |
| ACCORD HEALTHCARE INC | 211961 | AP (A-rated, therapeutically equivalent) | June 24, 2019 | 500MG/VIAL |
| BE PHARMACEUTICALS AG | 212513 | AP (A-rated, therapeutically equivalent) | June 26, 2019 | 500MG/VIAL |
| SAGENT PHARMACEUTICALS INC | 207104 | AP (A-rated, therapeutically equivalent) | November 15, 2019 | 500MG/VIAL |
| HISUN PHARMACEUTICAL HANGZHOU CO LTD | 212250 | AP (A-rated, therapeutically equivalent) | April 21, 2021 | 500MG/VIAL |
| MEITHEAL PHARMACEUTICALS INC | 213623 | AP (A-rated, therapeutically equivalent) | June 29, 2021 | 500MG/VIAL |
| QILU PHARMACEUTICAL HAINAN CO LTD | 215316 | AP (A-rated, therapeutically equivalent) | August 24, 2021 | 500MG/VIAL |
| EUGIA PHARMA SPECIALITIES LTD | 213171 | AP (A-rated, therapeutically equivalent) | September 2, 2021 | 500MG/VIAL |
| HAINAN POLY PHARMACEUTICAL CO LTD | 215890 | AP (A-rated, therapeutically equivalent) | August 18, 2022 | 500MG/VIAL |
| ASPIRO PHARMA LTD | 216413 | AP (A-rated, therapeutically equivalent) | September 23, 2022 | 500MG/VIAL |
| MYLAN PHARMACEUTICALS INC A VIATRIS CO | 213966 | AP (A-rated, therapeutically equivalent) | August 7, 2023 | 500MG/VIAL |
| BIOCON PHARMA LTD | 217215 | AP (A-rated, therapeutically equivalent) | August 29, 2024 | 500MG/VIAL |
Dapzura Rt patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11173189 | March 11, 2041 | Drug product | U-3294 | 213645 |
Dapzura Rt NDC codes
Questions
Is there a generic for Dapzura Rt?
Yes. The generic name for Dapzura Rt is daptomycin. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Dapzura Rt?
The active ingredient in Dapzura Rt is daptomycin, per the FDA Orange Book.
When does the Dapzura Rt patent expire?
The last patent listed for Dapzura Rt in the Orange Book expires March 11, 2041. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.