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Last Updated: March 19, 2024

SUFENTANIL CITRATE - Generic Drug Details


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What are the generic sources for sufentanil citrate and what is the scope of freedom to operate?

Sufentanil citrate is the generic ingredient in three branded drugs marketed by Rising, Hikma, Hospira, Watson Labs, and Vertical Pharms, and is included in five NDAs. There are twenty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sufentanil citrate has one hundred and five patent family members in twenty countries.

There are five drug master file entries for sufentanil citrate. Three suppliers are listed for this compound.

Summary for SUFENTANIL CITRATE
International Patents:105
US Patents:20
Tradenames:3
Applicants:5
NDAs:5
Drug Master File Entries: 5
Finished Product Suppliers / Packagers: 3
Raw Ingredient (Bulk) Api Vendors: 31
Clinical Trials: 7
Patent Applications: 1,119
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in SUFENTANIL CITRATE?SUFENTANIL CITRATE excipients list
DailyMed Link:SUFENTANIL CITRATE at DailyMed
Recent Clinical Trials for SUFENTANIL CITRATE

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

SponsorPhase
Brugmann University HospitalPhase 3
Jiangang SongN/A
West China HospitalPhase 4

See all SUFENTANIL CITRATE clinical trials

Pharmacology for SUFENTANIL CITRATE
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for SUFENTANIL CITRATE

US Patents and Regulatory Information for SUFENTANIL CITRATE

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vertical Pharms DSUVIA sufentanil citrate TABLET;SUBLINGUAL 209128-001 Nov 2, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vertical Pharms DSUVIA sufentanil citrate TABLET;SUBLINGUAL 209128-001 Nov 2, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Vertical Pharms DSUVIA sufentanil citrate TABLET;SUBLINGUAL 209128-001 Nov 2, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Vertical Pharms DSUVIA sufentanil citrate TABLET;SUBLINGUAL 209128-001 Nov 2, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Hikma SUFENTANIL CITRATE sufentanil citrate INJECTABLE;INJECTION 074413-001 Dec 15, 1995 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vertical Pharms DSUVIA sufentanil citrate TABLET;SUBLINGUAL 209128-001 Nov 2, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 SUFENTANIL CITRATE

Country Patent Number Title Estimated Expiration
Japan 2009536147 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2008085764 ⤷  Try a Trial
China 102231980 Sufentanil solid dosage forms comprising oxygen scavengers and methods of using the same ⤷  Try a Trial
South Korea 20100014380 STORAGE AND DISPENSING DEVICES FOR ADMINSISTRATION OF ORAL TRANSMUCOSAL DOSAGE FORMS ⤷  Try a Trial
Spain 2396150 ⤷  Try a Trial
South Korea 20140044949 STORAGE AND DISPENSING DEVICES FOR ADMINSISTRATION OF ORAL TRANSMUCOSAL DOSAGE FORMS ⤷  Try a Trial
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) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SUFENTANIL CITRATE

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

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