Dalvance Patent Expiration

Dalvance is a drug owned by Abbvie Inc. It is protected by 4 US drug patents filed in 2014. Out of these, 1 drug patents are active and 3 have expired. Dalvance's patents have been open to challenges since 24 May, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be May 23, 2028. Details of Dalvance's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6900175 Methods of administering dalbavancin for treatment of bacterial infections
May, 2028

(3 years from now)

Active
US8143212 Dalbavancin compositions for treatment of bacterial infections
Nov, 2023

(10 months ago)

Expired
US7119061 Dalbavancin compositions for treatment of bacterial infections
Nov, 2023

(10 months ago)

Expired
US7115564 Stable pharmaceutical compositions of dalbavancin and methods of administration
Nov, 2023

(10 months ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Dalvance's patents.

Given below is the list of recent legal activities going on the following patents of Dalvance.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 10 Aug, 2023 US8143212
Patent Term Extension Certificate 23 Oct, 2020 US6900175
Notice of Final Determination -Eligible 15 Jul, 2020 US6900175
Payment of Maintenance Fee, 8th Year, Large Entity 27 Sep, 2019 US8143212
FDA Final Eligibility Letter 03 Jul, 2019 US6900175
Payment of Maintenance Fee, 12th Year, Large Entity 10 Apr, 2018 US7119061
Payment of Maintenance Fee, 12th Year, Large Entity 03 Apr, 2018 US7115564
transaction for FDA Determination of Regulatory Review Period 12 Feb, 2018 US6900175
transaction for FDA Determination of Regulatory Review Period 23 Mar, 2017 US6900175
Second letter to regulating agency to determine regulatory review period 03 Nov, 2016 US6900175


FDA has granted several exclusivities to Dalvance. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Dalvance, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Dalvance.

Exclusivity Information

Dalvance holds 4 exclusivities. All of its exclusivities have expired in 2024. Details of Dalvance's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Dosing Schedule(D-154) Jan 20, 2019
New Chemical Entity Exclusivity(NCE) May 23, 2019
Generating Antibiotic Incentives Now(GAIN) May 23, 2024
New Patient Population(NPP) Jul 22, 2024

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Several oppositions have been filed on Dalvance's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Dalvance's generic, the next section provides detailed information on ongoing and past EP oppositions related to Dalvance patents.

Dalvance's Oppositions Filed in EPO

Dalvance has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jul 30, 2019, by Fresenius Kabi Deutschland Gmbh. This opposition was filed on patent number EP03789744A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP03789744A Jul, 2019 Fresenius Kabi Deutschland GmbH Granted and Under Opposition


US patents provide insights into the exclusivity only within the United States, but Dalvance is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Dalvance's family patents as well as insights into ongoing legal events on those patents.

Dalvance's Family Patents

Dalvance has patent protection in a total of 20 countries. It's US patent count contributes only to 38.4% of its total global patent coverage. 2 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Dalvance.

Family Patents

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Generic Launch

Generic Release Date:

Dalvance's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 23, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Dalvance Generics:

There are no approved generic versions for Dalvance as of now.





About Dalvance

Dalvance is a drug owned by Abbvie Inc. It is used for treating acute bacterial skin and skin structure infections (ABSSSI) in both adults and pediatric patients. Dalvance uses Dalbavancin Hydrochloride as an active ingredient. Dalvance was launched by Abbvie in 2014.

Approval Date:

Dalvance was approved by FDA for market use on 23 May, 2014.

NCE-1 date:

NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Dalvance is 23 May, 2014, its NCE-1 date is estimated to be 24 May, 2023.

Active Ingredient:

Dalvance uses Dalbavancin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Dalbavancin Hydrochloride ingredient

Treatment:

Dalvance is used for treating acute bacterial skin and skin structure infections (ABSSSI) in both adults and pediatric patients.

Dosage:

Dalvance is available in powder form for intravenous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 500MG BASE/VIAL POWDER Prescription INTRAVENOUS