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 |
| US11676691 | Storage and dispensing devices for administration of oral transmucosal dosage forms |
Mar, 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 |
| US10896751 | Storage and dispensing devices for administration of oral transmucosal dosage forms |
Mar, 2030
(5 years from now) | Active |
| US8231900 | Small-volume oral transmucosal dosage |
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 |
| 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 |
| US10245228 | 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 |
| 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 |
| 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 |
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.
Latest 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 |
|---|---|---|
 | ||
| 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 Critical | 09 Jan, 2024 | US8778393 |
| Change in Power of Attorney (May Include Associate POA) Critical | 09 Jan, 2024 | US8778393 |
| Change in Power of Attorney (May Include Associate POA) Critical | 20 Dec, 2023 | US8778393 |
| Email Notification Critical | 20 Dec, 2023 | US8778393 |
| Email Notification Critical | 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 |
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
Explore Our Curated Drug Screens
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 |