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Last Updated: June 15, 2024

DSUVIA Drug Patent Profile


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When do Dsuvia patents expire, and what generic alternatives are available?

Dsuvia is a drug marketed by Vertical Pharms and is included in one NDA. There are twenty patents protecting this drug.

This drug has one hundred and five patent family members in twenty countries.

The generic ingredient in DSUVIA is sufentanil citrate. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the sufentanil citrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dsuvia

A generic version of DSUVIA was approved as sufentanil citrate by HIKMA on December 15th, 1995.

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Summary for DSUVIA
Drug patent expirations by year for DSUVIA
Drug Prices for DSUVIA

See drug prices for DSUVIA

Recent Clinical Trials for DSUVIA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
United States Department of DefensePhase 3
Frank GuyettePhase 3
Montefiore Medical CenterPhase 4

See all DSUVIA clinical trials

Pharmacology for DSUVIA
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Anatomical Therapeutic Chemical (ATC) Classes for DSUVIA

US Patents and Regulatory Information for DSUVIA

DSUVIA is protected by twenty US patents.

Patents protecting DSUVIA

Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACUTE PAIN

Small-volume oral transmucosal dosage forms
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
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Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACUTE PAIN

Storage and dispensing devices for administration of oral transmucosal dosage forms
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Patent Expiration: ⤷  Sign Up


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Patent Expiration: ⤷  Sign Up


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Small-volume oral transmucosal dosage forms
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACUTE PAIN

Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACUTE PAIN

Small-volume oral transmucosal dosage
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Patent Expiration: ⤷  Sign Up

Bioadhesive drug formulations for oral transmucosal delivery
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Patent Expiration: ⤷  Sign Up

Bioadhesive drug formulations for oral transmucosal delivery
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Patent Expiration: ⤷  Sign Up

Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACUTE PAIN

Storage and dispensing devices for administration of oral transmucosal dosage forms
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACUTE PAIN

Small-volume oral transmucosal dosage forms
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACUTE PAIN

Bioadhesive drug formulations for oral transmucosal delivery
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACUTE PAIN

Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACUTE PAIN

Sufentanil solid dosage forms comprising oxygen scavengers and methods of using the same
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Patent Expiration: ⤷  Sign Up

Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACUTE PAIN

Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vertical Pharms DSUVIA sufentanil citrate TABLET;SUBLINGUAL 209128-001 Nov 2, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Vertical Pharms DSUVIA sufentanil citrate TABLET;SUBLINGUAL 209128-001 Nov 2, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Vertical Pharms DSUVIA sufentanil citrate TABLET;SUBLINGUAL 209128-001 Nov 2, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Vertical Pharms DSUVIA sufentanil citrate TABLET;SUBLINGUAL 209128-001 Nov 2, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Vertical Pharms DSUVIA sufentanil citrate TABLET;SUBLINGUAL 209128-001 Nov 2, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Vertical Pharms DSUVIA sufentanil citrate TABLET;SUBLINGUAL 209128-001 Nov 2, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for DSUVIA

See the table below for patents covering DSUVIA around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 2808005 Dispositifs de stockage et de distribution destinés à l'administration de formes pharmaceutiques transmucosiques orales (Storage and dispensing devices for administration of oral transmucosal dosage forms) ⤷  Sign Up
European Patent Office 2099406 Dispositifs de stockage et de distribution destinés à l'administration de formes pharmaceutiques transmucosiques orales (Storage and dispensing devices for administration of oral transmucosal dosage forms) ⤷  Sign Up
South Korea 101545754 ⤷  Sign Up
China 103585021 Drug storage and dispensing device and system comprising the same ⤷  Sign Up
Australia 2009316874 Sufentanil solid dosage forms comprising oxygen scavengers and methods of using the same ⤷  Sign Up
China 113143769 用于分配口腔经粘膜剂型的设备和方法 (APPARATUS AND METHODS FOR DISPENSING ORAL TRANSMUCOSAL DOSAGE FORMS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DSUVIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2114383 122016000023 Germany ⤷  Sign Up PRODUCT NAME: SUFENTANIL, WAHLWEISE IN FORM VON SUFENTANILCITRAT; REGISTRATION NO/DATE: EU/1/15/1042 20150918
2114383 CR 2016 00007 Denmark ⤷  Sign Up PRODUCT NAME: SUFENTANIL; REG. NO/DATE: EU/1/15/1042/001-006 20150922
2114383 CA 2016 00007 Denmark ⤷  Sign Up PRODUCT NAME: SUFENTANIL, HERUNDER SUFENTANIL SOM CITRAT; REG. NO/DATE: EU/1/15/1042/001-006 20150922
2114383 300797 Netherlands ⤷  Sign Up PRODUCT NAME: SUFENTANIL, DESGEWENST IN DE VORM VAN SUFENTANILCITRAAT; REGISTRATION NO/DATE: EU/1/15/1042 20150922
2114383 SPC/GB16/004 United Kingdom ⤷  Sign Up PRODUCT NAME: SUFENTANIL; REGISTERED: UK EU/1/15/1042 20150922
2114383 16C0010 France ⤷  Sign Up PRODUCT NAME: SUFENTANIL; REGISTRATION NO/DATE: EU/1/15/1042 20150918
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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