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DSUVIA Drug Profile
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» See Plans and PricingWhich patents cover Dsuvia, and what generic alternatives are available?
Dsuvia is a drug marketed by Acelrx Pharms and is included in one NDA. There are seventeen patents protecting this drug.
This drug has eighty-seven patent family members in nineteen countries.
The generic ingredient in DSUVIA is sufentanil citrate. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the sufentanil citrate profile page.
US ANDA Litigation and Generic Entry Outlook for Dsuvia
A generic version of DSUVIA was approved as sufentanil citrate by WEST-WARD PHARMS INT on December 15th, 1995.
Summary for DSUVIA
| International Patents: | 87 |
| US Patents: | 17 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 18 |
| Clinical Trials: | 1 |
| Patent Applications: | 5,455 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DSUVIA |
| DailyMed Link: | DSUVIA at DailyMed |
Recent Clinical Trials for DSUVIA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Minnesota | Phase 4 |
Pharmacology for DSUVIA
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
US Patents and Regulatory Information for DSUVIA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acelrx Pharms | DSUVIA | sufentanil citrate | TABLET;SUBLINGUAL | 209128-001 | Nov 2, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Acelrx Pharms | DSUVIA | sufentanil citrate | TABLET;SUBLINGUAL | 209128-001 | Nov 2, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Acelrx Pharms | DSUVIA | sufentanil citrate | TABLET;SUBLINGUAL | 209128-001 | Nov 2, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Acelrx Pharms | DSUVIA | sufentanil citrate | TABLET;SUBLINGUAL | 209128-001 | Nov 2, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 101730516 | Start Trial |
| Canada | 2636088 | Start Trial |
| Japan | 2012509325 | Start Trial |
| South Korea | 101451451 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for DSUVIA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2114383 | CA 2016 00007 | Denmark | Start Trial | PRODUCT NAME: SUFENTANIL, HERUNDER SUFENTANIL SOM CITRAT; REG. NO/DATE: EU/1/15/1042/001-006 20150922 |
| 2114383 | 300797 | Netherlands | Start Trial | PRODUCT NAME: SUFENTANIL, DESGEWENST IN DE VORM VAN SUFENTANILCITRAAT; REGISTRATION NO/DATE: EU/1/15/1042 20150922 |
| 2114383 | 122016000023 | Germany | Start Trial | PRODUCT NAME: SUFENTANIL, WAHLWEISE IN FORM VON SUFENTANILCITRAT; REGISTRATION NO/DATE: EU/1/15/1042 20150918 |
| 2114383 | 16C0010 | France | Start Trial | PRODUCT NAME: SUFENTANIL; REGISTRATION NO/DATE: EU/1/15/1042 20150918 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
