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Last Updated: January 16, 2021

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DALVANCE Drug 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-seven patent family members in twenty countries.

The generic ingredient in DALVANCE is dalbavancin hydrochloride. Additional details are available on the dalbavancin hydrochloride profile page.

US ANDA Litigation and 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 May 23, 2024. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for DALVANCE
International Patents:57
US Patents:4
Applicants:1
NDAs:1
Bulk Api Vendors: 3
Clinical Trials: 4
Drug Prices: Drug price information for DALVANCE
DailyMed Link:DALVANCE at DailyMed
Drug patent expirations by year for DALVANCE
Drug Prices for DALVANCE

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Generic Entry Opportunity Date for DALVANCE
Generic Entry Date for DALVANCE*:
Constraining patent/regulatory exclusivity:
FDA exclusivity
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
Johns Hopkins UniversityPhase 4
Infectious Diseases Physicians, Inc.Phase 4

See all DALVANCE clinical trials

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

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Serving leading biopharmaceutical companies globally:

Moodys
AstraZeneca
Merck
Medtronic
Express Scripts
McKinsey

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.