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Last Updated: October 20, 2019

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Fentanyl hydrochloride - Generic Drug Details

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What are the generic sources for fentanyl hydrochloride and what is the scope of freedom to operate?

Fentanyl hydrochloride is the generic ingredient in one branded drug marketed by The Medicines Co and is included in one NDA. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fentanyl hydrochloride has one hundred and sixty-eight patent family members in thirty-three countries.

There are thirty-one drug master file entries for fentanyl hydrochloride. One supplier is listed for this compound.

Summary for fentanyl hydrochloride
Recent Clinical Trials for fentanyl hydrochloride

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

SponsorPhase
Helse FonnaPhase 4
University Hospital, AkershusN/A
Keith M. Vogt, MD, PhDPhase 4

See all fentanyl hydrochloride clinical trials

Pharmacology for fentanyl hydrochloride
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Synonyms for fentanyl hydrochloride
137102-75-1
1443-54-5
59H156XY46
AC1L36GM
AC1Q3E0D
Acetamide, N-phenyl-N-(1-(2-phenylethyl)-4-piperidinyl)-, monohydrochloride
CHEMBL1201159
D10811
DTXSID90162666
Fentanyl HCl
Fentanyl hydrochloride (JAN)
Fentanyl monohydrochloride
FT-0701144
Ionsys (TN)
LS-124440
MCV 4848
MLS002320669
n-(1-phenethyl-4-piperidyl)-n-phenyl-propanamide hydrochloride
N-(1-Phenethyl-4-piperidyl)propionanilide hydrochloride
N-(1-phenethylpiperidin-4-yl)-N-phenylpropanamide hydrochloride
NIH 10485
Propionanilide, N-(1-phenethyl-4-piperidyl)-, hydrochloride
SCHEMBL242876
SMR001338815
UNII-59H156XY46

US Patents and Regulatory Information for fentanyl hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 DISCN Yes No   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

Expired US Patents for fentanyl hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006   Start Trial   Start Trial
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006   Start Trial   Start Trial
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for fentanyl hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0383579 C960030 Netherlands   Start Trial PRODUCT NAME: REMIFENTANYLUM, DESGEWENST IN DE VORM VAN EEN ZUURADDITIE-ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20601 - RVG 20603 19961015; 36335.00.00, 36335.01.00, 36335.02.00 19960517
1635783 CA 2014 00016 Denmark   Start Trial PRODUCT NAME: FENTANYL I EN HVILKEN SOM HELST AF DE FORMER, DER ER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/10/644/001-006 20100831
1635783 300653 Netherlands   Start Trial PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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