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Last Updated: January 27, 2023

Sufentanil citrate - Generic Drug Details

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What are the generic drug 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, Hikma, Hospira, Watson Labs, and Acelrx Pharms, and is included in five NDAs. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sufentanil citrate has ninety-two patent family members in nineteen countries.

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

Summary for sufentanil citrate
International Patents:92
US Patents:18
Drug Master File Entries: 5
Finished Product Suppliers / Packagers: 4
Raw Ingredient (Bulk) Api Vendors: 28
Clinical Trials: 6
Patent Applications: 1,177
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

Jiangang SongN/A
West China HospitalPhase 4
Zhejiang Cancer HospitalN/A

See all sufentanil citrate clinical trials

Pharmacology for sufentanil citrate
Drug Class Opioid 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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Acelrx Pharms DSUVIA sufentanil citrate TABLET;SUBLINGUAL 209128-001 Nov 2, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma SUFENTANIL CITRATE sufentanil citrate INJECTABLE;INJECTION 074413-001 Dec 15, 1995 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 SPC/GB16/004 United Kingdom See Plans and Pricing PRODUCT NAME: SUFENTANIL; REGISTERED: UK EU/1/15/1042 20150922
2114383 CA 2016 00007 Denmark See Plans and Pricing PRODUCT NAME: SUFENTANIL, HERUNDER SUFENTANIL SOM CITRAT; REG. NO/DATE: EU/1/15/1042/001-006 20150922
2114383 122016000023 Germany See Plans and Pricing PRODUCT NAME: SUFENTANIL, WAHLWEISE IN FORM VON SUFENTANILCITRAT; REGISTRATION NO/DATE: EU/1/15/1042 20150918
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.