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
(1 year, 1 month ago) |
Expired
|
| US7119061 | Dalbavancin compositions for treatment of bacterial infections |
Nov, 2023
(1 year, 1 month ago) |
Expired
|
| US7115564 | Stable pharmaceutical compositions of dalbavancin and methods of administration |
Nov, 2023
(1 year, 1 month 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.
Latest 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 |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 10 Aug, 2023 | US8143212 |
| Patent Term Extension Certificate Critical | 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 Critical | 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 |
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 |
|---|---|---|---|
 | |||
| 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
Explore Our Curated Drug Screens
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 |