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Last Updated: November 13, 2019

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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, Hospira, Watson Labs, West-ward Pharms Int, and Acelrx Pharms, and is included in five NDAs. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sufentanil citrate has eighty-four 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
Synonyms for sufentanil citrate
2-hydroxypropane-1,2,3-tricarboxylic acid; N-[4-(methoxymethyl)-1-(2-thiophen-2-ylethyl)piperidin-4-yl]-N-phenylpropanamide
4074AH
56030-54-7 (Parent)
60561-17-3
AC1L23CS
AKOS027325565
API0004254
ARX-01
ARX-02
ARX-F01
C22H30N2O2S.C6H8O7
CAS-60561-17-3
CHEBI:9317
CHEMBL1201163
CS-3051
D00845
DSSTox_CID_28854
DSSTox_GSID_48928
DSSTox_RID_83123
DTXSID5048928
EINECS 262-295-4
EN-3270
Fentatienil
FT-0674738
HMS2272F05
HY-13754A
LS-124419
N-(4-(Methoxymethyl)-1-(2-(2-thienyl)ethyl)-4-piperidinyl)-N-phenylpropionamide citrate
N-(4-(Methoxymethyl)-1-(2-(2-thienyl)ethyl)-4-piperidyl)-N-phenylpropionamide citrate
N-(4-(Methoxymethyl)-1-(2-(2-thienyl)ethyl)-4-piperidyl)propionanilide citrate
N-(4-(Methoxymethyl)-1-(2-(2-thienyl)ethyl)-4-piperidyl)propionanilide citrate (1:1)
N-(4-(methoxymethyl)-1-(2-(thiophen-2-yl)ethyl)piperidin-4-yl)-N-phenylpropionamide citrate
N-[4-(Methoxymethyl)-1-[2-(2-thienyl)ethyl]-4-piperidinyl]-N-phenyl, propanamide 2-Hydroxy-1,2,3-propanetricarboxylate
OJCZPLDERGDQRJ-UHFFFAOYSA-N
Propanamide, N-(4-(methoxymethyl)-1-(2-(thienyl)ethyl)-4-piperidinyl)-N-phenyl-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)
Propionanilide, N-(4-(methoxymethyl)-1-(2-(2-thienyl)ethyl)-4-piperidyl)-, citrate
R 30730 citrate salt
R 33800
R-33800
R33800
S9ZFX8403R
SCHEMBL41227
Sufenta
Sufenta Preservative Free
Sufentanil (citrate)
Sufentanil citrate (USP)
Sufentanil citrate [USAN:USP]
Sufentanil citrate [USAN]
Sufentanil Citrate 0.1 mg/ml in Methanol (as free base)
Sufentanil Citrate solution, 100 mug/mL in methanol (as free base), ampule of 1 mL, certified reference material
Sufentanil Forte
Sufentanil TDS
Sufentanyl Citrat
Sufentanyl citrate
Tox21_112879
TRANSDUR-Sufentanil
UNII-S9ZFX8403R

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
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
>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 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 CR 2016 00007 Denmark   Start Trial PRODUCT NAME: SUFENTANIL; REG. NO/DATE: EU/1/15/1042/001-006 20150922
2114383 CA 2016 00007 Denmark   Start Trial PRODUCT NAME: SUFENTANIL, HERUNDER SUFENTANIL SOM CITRAT; REG. NO/DATE: EU/1/15/1042/001-006 20150922
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Express Scripts
Johnson and Johnson
Mallinckrodt
Boehringer Ingelheim
McKinsey

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