FDA Orange Book · active-ingredient family
Dalbavancin hydrochloride
Dalbavancin hydrochloride is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DALVANCE · NDA 021883
1
Brand (NDA)
5
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DALVANCERLD | ABBVIE | NDA 021883 | AP | May 23, 2014 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DALBAVANCIN HYDROCHLORIDE | BE PHARMS | ANDA 219604 | AP | Jun 04, 2026 | |
| DALBAVANCIN HYDROCHLORIDE | LONG GROVE PHARMS | ANDA 218602 | AP | Feb 26, 2026 | |
| DALBAVANCIN HYDROCHLORIDE | KINDOS | ANDA 218929 | AP | Nov 26, 2025 | |
| DALBAVANCIN HYDROCHLORIDE | FRESENIUS KABI USA | ANDA 217591 | AP | Nov 10, 2025 | |
| DALBAVANCIN HYDROCHLORIDE | TEVA PHARMS INC | ANDA 219465 | AP | Oct 23, 2025 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 6900175 | May 23, 2028 | in 1 yr 11 mo | U-3499 |
Dalbavancin hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
