Dsuvia Patent Expiration

Dsuvia is a drug owned by Vertical Pharmaceuticals Llc. It is protected by 21 US drug patents filed from 2018 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 02, 2038. Details of Dsuvia'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).
US11672738 Apparatus and methods for dispensing oral transmucosal dosage forms
Feb, 2038

(13 years from now)

Active
US8945592 Sufentanil solid dosage forms comprising oxygen scavengers and methods of using the same
Jul, 2031

(6 years from now)

Active
US8202535 Small-volume oral transmucosal dosage forms
Oct, 2030

(5 years from now)

Active
US8865743 Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Oct, 2030

(5 years from now)

Active
US8574189 Storage and dispensing devices for administration of oral transmucosal dosage forms
Mar, 2030

(5 years from now)

Active
US12033733 Storage and dispensing devices for administration of oral transmucosal dosage forms
Mar, 2030

(5 years from now)

Active
US11676691 Storage and dispensing devices for administration of oral transmucosal dosage forms
Mar, 2030

(5 years from now)

Active
US10896751 Storage and dispensing devices for administration of oral transmucosal dosage forms
Mar, 2030

(5 years from now)

Active
US9744129 Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Jan, 2027

(2 years from now)

Active
US8252329 Bioadhesive drug formulations for oral transmucosal delivery
Jan, 2027

(2 years from now)

Active
US10342762 Small-volume oral transmucosal dosage forms
Jan, 2027

(2 years from now)

Active
US8252328 Bioadhesive drug formulations for oral transmucosal delivery
Jan, 2027

(2 years from now)

Active
US8778393 Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Jan, 2027

(2 years from now)

Active
US8231900 Small-volume oral transmucosal dosage
Jan, 2027

(2 years from now)

Active
US9320710 Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Jan, 2027

(2 years from now)

Active
US8226978 Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Jan, 2027

(2 years from now)

Active
US8865211 Bioadhesive drug formulations for oral transmucosal delivery
Jan, 2027

(2 years from now)

Active
US10245228 Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Jan, 2027

(2 years from now)

Active
US10507180 Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Jan, 2027

(2 years from now)

Active
US8535714 Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Jan, 2027

(2 years from now)

Active
US8778394 Small-volume oral transmucosal dosage forms
Jan, 2027

(2 years from now)

Active


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 Dsuvia's patents.

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

Activity Date Patent Number
Patent litigations
Entity Status Set To Undiscounted (Initial Default Setting or Status Change) 12 Apr, 2024 US10896751
Payment of Maintenance Fee, 12th Year, Large Entity 28 Feb, 2024 US8252329
Payment of Maintenance Fee, 12th Year, Large Entity 28 Feb, 2024 US8252328
Payment of Maintenance Fee, 12th Year, Large Entity 31 Jan, 2024 US8231900
Payment of Maintenance Fee, 12th Year, Large Entity 24 Jan, 2024 US8226978
Email Notification 09 Jan, 2024 US8778393
Change in Power of Attorney (May Include Associate POA) 09 Jan, 2024 US8778393
Change in Power of Attorney (May Include Associate POA) 20 Dec, 2023 US8778393
Email Notification 20 Dec, 2023 US8778393
Email Notification 19 Dec, 2023 US11676691


FDA has granted several exclusivities to Dsuvia. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Dsuvia, 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 Dsuvia.

Exclusivity Information

Dsuvia holds 1 exclusivities. All of its exclusivities have expired in 2021. Details of Dsuvia's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Nov 02, 2021

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Get the exclusive patent insights now. Don't be the last to know.

US patents provide insights into the exclusivity only within the United States, but Dsuvia 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 Dsuvia's family patents as well as insights into ongoing legal events on those patents.

Dsuvia's Family Patents

Dsuvia has patent protection in a total of 19 countries. It's US patent count contributes only to 38.8% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Dsuvia.

Family Patents

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Generic Launch

Generic Release Date:

Dsuvia's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 02, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Dsuvia Generic API suppliers:

Sufentanil Citrate is the generic name for the brand Dsuvia. 3 different companies have already filed for the generic of Dsuvia, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Dsuvia's generic





About Dsuvia

Dsuvia is a drug owned by Vertical Pharmaceuticals Llc. It is used for managing acute pain. Dsuvia uses Sufentanil Citrate as an active ingredient. Dsuvia was launched by Vertical Pharms in 2018.

Approval Date:

Dsuvia was approved by FDA for market use on 02 November, 2018.

Active Ingredient:

Dsuvia uses Sufentanil Citrate as the active ingredient. Check out other Drugs and Companies using Sufentanil Citrate ingredient

Treatment:

Dsuvia is used for managing acute pain.

Dosage:

Dsuvia is available in tablet form for sublingual use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 0.03MG BASE TABLET Prescription SUBLINGUAL