Fentanyl hydrochloride - Generic Drug Details

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What are the generic sources for fentanyl hydrochloride and what is the scope of patent protection?

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

Fentanyl hydrochloride has eighty-nine patent family members in eighteen countries.

There are two drug master file entries for fentanyl hydrochloride.

Summary for fentanyl hydrochloride

International Patents:	89
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Raw Ingredient (Bulk) Api Vendors:	12
Clinical Trials:	1,654
Patent Applications:	136
Formulation / Manufacturing:	see details
DailyMed Link:	fentanyl hydrochloride at DailyMed

Recent Clinical Trials for fentanyl hydrochloride

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

Sponsor	Phase
University of Alabama at Birmingham	Phase 1
Merck Sharp & Dohme LLC	N/A
University Hospital "Sestre Milosrdnice"	N/A

See all fentanyl hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for fentanyl hydrochloride

N01AH	Opioid anesthetics
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

N02AB	Phenylpiperidine derivatives
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

US Patents and Regulatory Information for fentanyl hydrochloride

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Glossary

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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	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
The Medicines Co	IONSYS	fentanyl hydrochloride	SYSTEM;IONTOPHORESIS, TRANSDERMAL	021338-001	May 22, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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

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

International Patents for fentanyl hydrochloride

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Country	Patent Number	Title	Estimated Expiration
Japan	2015517382	鎮痛剤製品用の自己試験	⤷ Sign Up
Singapore	11201407396V	SELF-TEST FOR ANALGESIC PRODUCT	⤷ Sign Up
Mexico	2013010199	CIRCUITO Y METODO DE VALIDACION DE INTERRUPTOR. (SWITCH VALIDATION CIRCUIT AND METHOD.)	⤷ Sign Up
Mexico	347308	AUTOPRUEBA PARA PRODUCTO ANALGESICO. (SELF-TEST FOR ANALGESIC PRODUCT.)	⤷ Sign Up
Israel	228162	מכשיר להעברה חשמלית בעל שני חלקים (Two-part electrotransport device)	⤷ Sign Up
Australia	2013274873	Current control for electrotransport drug delivery	⤷ Sign Up
Denmark	2858715		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for fentanyl hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1635783	300653	Netherlands	⤷ Sign Up	PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
1635783	122014000024	Germany	⤷ Sign Up	PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
0383579	C960030	Netherlands	⤷ Sign Up	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
0975367	122011000009	Germany	⤷ Sign Up	PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
1769785	C300522	Netherlands	⤷ Sign Up	PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
1635783	CA 2014 00016	Denmark	⤷ Sign Up	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
1769785	C300521	Netherlands	⤷ Sign Up	PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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