FDA Orange Book · active-ingredient family
Daptomycin
Daptomycin: 7 brands, 25 generics; first approved Sep 12, 2003; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 25 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
7
Generics (ANDA)
25
Listed patents
8
Next patent expiry
Sep 04, 2028
in 2 yr 1 mo
Brand (NDA) products
Originator applications
- DAPTOMYCINRLDMAIA PHARMS INCNDA 21763020242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG/VIAL POWDER INTRAVENOUS Discontinued — 500MG/VIAL POWDER INTRAVENOUS Rx — - DAPTOMYCINRLDRSHIKMANDA 21741520232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG/VIAL POWDER INTRAVENOUS Rx — 500MG/VIAL POWDER INTRAVENOUS Rx — - DAPZURA RTRLDBAXTER HLTHCARE CORPNDA 21364520225 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL POWDER INTRAVENOUS Discontinued — 350MG/50ML (7MG/ML) SOLUTION INTRAVENOUS Rx — 500MG/50ML (10MG/ML) SOLUTION INTRAVENOUS Rx — 700MG/100ML (7MG/ML) SOLUTION INTRAVENOUS Rx — 1GM/100ML (10MG/ML) SOLUTION INTRAVENOUS Rx — - DAPTOMYCINRLDRSHOSPIRANDA 21028220212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG/VIAL POWDER INTRAVENOUS Rx — 500MG/VIAL POWDER INTRAVENOUS Rx — - DAPTOMYCINRLDRSHIKMANDA 2099492017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG/VIAL POWDER INTRAVENOUS Rx — - DAPTOMYCINRLDRSSAGENT PHARMS INCNDA 2083852017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG/VIAL POWDER INTRAVENOUS Rx AP - CUBICINRLDCUBIST PHARMS LLCNDA 02157220033 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/VIAL POWDER INTRAVENOUS Discontinued — 500MG/VIAL POWDER INTRAVENOUS Discontinued — 500MG/VIAL POWDER INTRAVENOUS Discontinued —
Generic (ANDA) products (25)
Abbreviated applications
- DAPTOMYCINBIOCON PHARMAANDA 2172152024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL POWDER INTRAVENOUS Rx AP - DAPTOMYCINFRESENIUS KABI USAANDA 2133962024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG/VIAL POWDER INTRAVENOUS Discontinued — - DAPTOMYCINMYLANANDA 2139662023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL POWDER INTRAVENOUS Rx AP - DAPTOMYCINASPIROANDA 2164452022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG/VIAL POWDER INTRAVENOUS Rx AP - DAPTOMYCINASPIROANDA 2164132022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL POWDER INTRAVENOUS Rx AP - DAPTOMYCINHAINAN POLY PHARMANDA 2158902022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL POWDER INTRAVENOUS Rx AP - DAPTOMYCINHANGZHOU ZHONGMEIANDA 2152152021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL POWDER INTRAVENOUS Discontinued — - DAPTOMYCINEUGIA PHARMAANDA 2131712021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL POWDER INTRAVENOUS Rx AP - DAPTOMYCINRSQILU PHARM HAINANANDA 2153162021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL POWDER INTRAVENOUS Rx AP - DAPTOMYCINMEITHEALANDA 2137862021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG/VIAL POWDER INTRAVENOUS Rx AP - DAPTOMYCINMEITHEALANDA 2136232021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL POWDER INTRAVENOUS Rx AP - DAPTOMYCINHISUN PHARM HANGZHOUANDA 2122502021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL POWDER INTRAVENOUS Rx AP - DAPTOMYCINDR REDDYSANDA 2114032020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG/VIAL POWDER INTRAVENOUS Rx AP - DAPTOMYCINBE PHARMSANDA 2134252020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG/VIAL POWDER INTRAVENOUS Rx AP - DAPTOMYCINSAGENT PHARMS INCANDA 2071042019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL POWDER INTRAVENOUS Rx AP - DAPTOMYCINHENGRUI PHARMAANDA 2120222019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL POWDER INTRAVENOUS Discontinued — - DAPTOMYCINACCORD HLTHCAREANDA 2126672019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 350MG/VIAL POWDER INTRAVENOUS Rx AP - DAPTOMYCINBE PHARMSANDA 2125132019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL POWDER INTRAVENOUS Rx AP - DAPTOMYCINACCORD HLTHCAREANDA 2119612019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL POWDER INTRAVENOUS Rx AP - DAPTOMYCINDR REDDYSANDA 2083752019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL POWDER INTRAVENOUS Rx AP - DAPTOMYCINMYLAN LABS LTDANDA 2050372018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL POWDER INTRAVENOUS Rx AP - DAPTOMYCINFRESENIUS KABI USAANDA 2060772018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL POWDER INTRAVENOUS Rx AP - DAPTOMYCINXELLIA PHARMS APSANDA 2060052016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL POWDER INTRAVENOUS Rx AP - DAPTOMYCINTEVA PHARMS USAANDA 0910392016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL POWDER INTRAVENOUS Rx AP - DAPTOMYCINHOSPIRAANDA 2028572014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/VIAL POWDER INTRAVENOUS Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8003673 | in 2 yr 1 mo | U-1180 | |
| 9138456 | in 4 yr 4 mo | Product | |
| 10357535 | in 7 yr 2 mo | ProductU-3176 | |
| 9655946 | in 7 yr 2 mo | ProductU-3175 | |
| 12053502 | in 12 yr 2 mo | U-3981 | |
| 11759497 | in 12 yr 2 mo | Product | |
| 11173189 | in 14 yr 9 mo | ProductU-3294 | |
| 12629337 | in 16 yr 7 mo | Product |
Approval history
FDA approval span
First approval
23 yr 3 mo ago
Most recent approval
1 yr 9 mo ago
Approvals span 2003–2024 across 32 FDA applications.
Brand (NDA) 722%
Generic (ANDA) 2578%
Daptomycin: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
