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Last Updated: May 21, 2022

DALVANCE Drug Patent Profile


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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

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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
Drug patent expirations by year for DALVANCE
Drug Prices for DALVANCE

See drug prices for DALVANCE

DrugPatentWatch® Estimated Generic Entry Opportunity Date for DALVANCE
Generic Entry Date for DALVANCE*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION
NDA:
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

SponsorPhase
Wake Forest University Health SciencesPhase 4
University of Colorado, DenverPhase 2/Phase 3
AllerganPhase 4

See all DALVANCE clinical trials

US Patents and Regulatory Information for DALVANCE

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DALVANCE is See Plans and Pricing.

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

Methods of administering dalbavancin for treatment of bacterial infections
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BACTERIAL INFECTIONS USING A TWO-DOSE REGIMEN OF DALBAVANCIN.

Stable pharmaceutical compositions of dalbavancin and methods of administration
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dalbavancin compositions for treatment of bacterial infections
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dalbavancin compositions for treatment of bacterial infections
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BACTERIAL INFECTIONS USING A TWO-DOSE REGIMEN OF DALBAVANCIN.

FDA Regulatory Exclusivity protecting DALVANCE

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: See Plans and Pricing

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

International Patents for DALVANCE

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

Country Patent Number Title Estimated Expiration
Hong Kong 1114014 PHARMACEUTICAL COMPOSITION COMPRISING DALBAVANCIN See Plans and Pricing
Spain 2712656 See Plans and Pricing
Norway 20052362 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2006078277 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.