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Last Updated: July 2, 2020

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Sufentanil citrate - Generic Drug Details

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What are the generic sources for sufentanil citrate and what is the scope of patent protection?

Sufentanil citrate is the generic ingredient in three branded drugs marketed by Akorn, Hospira, Watson Labs, West-ward Pharms Int, and Acelrx Pharms, and is included in five NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sufentanil citrate has eighty-seven patent family members in nineteen countries.

There are nine drug master file entries for sufentanil citrate. Four suppliers are listed for this compound.

Summary for sufentanil citrate
Recent Clinical Trials for sufentanil citrate

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

SponsorPhase
West China HospitalPhase 4
Fudan UniversityN/A

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
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
West-ward Pharms Int SUFENTANIL CITRATE sufentanil citrate INJECTABLE;INJECTION 074413-001 Dec 15, 1995 AP RX No No   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

Supplementary Protection Certificates for sufentanil citrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2114383 16C0010 France   Start Trial PRODUCT NAME: SUFENTANIL; REGISTRATION NO/DATE: EU/1/15/1042 20150918
2114383 122016000023 Germany   Start Trial PRODUCT NAME: SUFENTANIL, WAHLWEISE IN FORM VON SUFENTANILCITRAT; REGISTRATION NO/DATE: EU/1/15/1042 20150918
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 CR 2016 00007 Denmark   Start Trial PRODUCT NAME: SUFENTANIL; 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Merck
Express Scripts
McKinsey
Baxter
McKesson

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