FDA Orange Book · active-ingredient family
Dalbavancin hydrochloride
Dalbavancin hydrochloride: 1 brand, 5 generics; first approved May 23, 2014; generic available.
Generic available
Generic status & protection
Generic available: 5 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
5
Listed patents
1
Next patent expiry
May 23, 2028
in 1 yr 8 mo
Brand (NDA) products
Originator applications
- ABBVIENDA 0218832014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL POWDER INTRAVENOUS Rx AP
Generic (ANDA) products (5)
Abbreviated applications
- DALBAVANCIN HYDROCHLORIDEBE PHARMSANDA 2196042026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL POWDER INTRAVENOUS Rx AP - DALBAVANCIN HYDROCHLORIDELONG GROVE PHARMSANDA 2186022026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL POWDER INTRAVENOUS Rx AP - DALBAVANCIN HYDROCHLORIDEKINDOSANDA 2189292025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL POWDER INTRAVENOUS Rx AP - DALBAVANCIN HYDROCHLORIDEFRESENIUS KABI USAANDA 2175912025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL POWDER INTRAVENOUS Rx AP - DALBAVANCIN HYDROCHLORIDETEVA PHARMS INCANDA 2194652025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL POWDER INTRAVENOUS Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 6900175 | in 1 yr 8 mo | U-3499 |
Approval history
FDA approval span
First approval
12 yr 7 mo ago
Most recent approval
4 mo ago
Approvals span 2014–2026 across 6 FDA applications.
Brand (NDA) 117%
Generic (ANDA) 583%
Dalbavancin hydrochloride: 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.
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