Is there a generic for Dalbavancin hydrochloride?

Yes. The FDA Orange Book lists 5 approved generic (ANDA) applications for Dalbavancin hydrochloride, referencing the brand DALVANCE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Dalbavancin hydrochloride?

DALVANCE (NDA 021883, ABBVIE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Dalbavancin hydrochloride?

The Orange Book lists 1 patent against Dalbavancin hydrochloride products, with the earliest listed expiry in 2028. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Dalbavancin hydrochloride are approved?

Dalbavancin hydrochloride is approved in the following dosage form: powder.

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 May 23, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

May 23, 2028

in 1 yr 11 mo

Originator applications

Brand (NDA) products

DALVANCERLDRS

ABBVIENDA 0218832014

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE/VIAL	POWDER	INTRAVENOUS	Rx	AP

Abbreviated applications

Generic (ANDA) products (5)

DALBAVANCIN HYDROCHLORIDE

BE PHARMSANDA 2196042026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE/VIAL	POWDER	INTRAVENOUS	Rx	AP

DALBAVANCIN HYDROCHLORIDE

LONG GROVE PHARMSANDA 2186022026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE/VIAL	POWDER	INTRAVENOUS	Rx	AP

DALBAVANCIN HYDROCHLORIDE

KINDOSANDA 2189292025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE/VIAL	POWDER	INTRAVENOUS	Rx	AP

DALBAVANCIN HYDROCHLORIDE

FRESENIUS KABI USAANDA 2175912025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE/VIAL	POWDER	INTRAVENOUS	Rx	AP

DALBAVANCIN HYDROCHLORIDE

TEVA PHARMS INCANDA 2194652025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE/VIAL	POWDER	INTRAVENOUS	Rx	AP

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
6900175	May 23, 2028	in 1 yr 11 mo	U-3499

FDA approval span

Approval history

First approval

May 23, 2014

12 yr 4 mo ago

Most recent approval

Jun 04, 2026

1 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.

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