DALVANCE Drug Patent Profile

When do Dalvance patents expire, and what generic alternatives are available?

Dalvance is a drug marketed by Allergan and is included in one NDA. There are four patents protecting this drug.

This drug has fifty-eight patent family members in twenty countries.

The generic ingredient in DALVANCE is dalbavancin hydrochloride. One supplier is listed for this compound. Additional details are available on the dalbavancin hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Dalvance

Dalvance was eligible for patent challenges on May 23, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 22, 2024. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DALVANCE

International Patents:	58
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	6
Patent Applications:	5
Drug Prices:	Drug price information for DALVANCE
What excipients (inactive ingredients) are in DALVANCE?	DALVANCE excipients list
DailyMed Link:	DALVANCE at DailyMed

See drug prices for DALVANCE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DALVANCE

Constraining patent/regulatory exclusivity:

NEW PATIENT POPULATION

NDA:

021883

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DALVANCE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Wake Forest University Health Sciences	Phase 4
University of Colorado, Denver	Phase 2/Phase 3
Allergan	Phase 4

See all DALVANCE clinical trials

Pharmacology for DALVANCE

Drug Class

Lipoglycopeptide Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for DALVANCE

J01XA	Glycopeptide antibacterials
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for DALVANCE

DALVANCE is protected by four US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on NEW PATIENT POPULATION.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting DALVANCE

FDA Regulatory Exclusivity protecting DALVANCE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	DALVANCE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	021883-001	May 23, 2014		RX	Yes	Yes
Allergan	DALVANCE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	021883-001	May 23, 2014		RX	Yes	Yes
Allergan	DALVANCE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	021883-001	May 23, 2014		RX	Yes	Yes			Y

International Patents for DALVANCE

See the table below for patents covering DALVANCE around the world.

Country	Patent Number	Title	Estimated Expiration
China	1711102	Use of dalbavancin compositions in preparation of medicament for treatment of bacterial infections
South Korea	101173310
Russian Federation	2005119206	СПОСОБЫ ВВЕДЕНИЯ ДАЛБАВАНЦИНА ДЛЯ ЛЕЧЕНИЯ БАКТЕРИАЛЬНЫХ ИНФЕКЦИЙ