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Last Updated: November 22, 2024

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
DailyMed Link:FENTANYL HYDROCHLORIDE at DailyMed
Recent Clinical Trials for FENTANYL HYDROCHLORIDE

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

SponsorPhase
University of Alabama at BirminghamPhase 1
Merck Sharp & Dohme LLCN/A
University Hospital "Sestre Milosrdnice"N/A

See all FENTANYL HYDROCHLORIDE clinical trials

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 ⤷  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 ⤷  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

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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for FENTANYL HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
New Zealand 701761 Self-test for analgesic product ⤷  Sign Up
Portugal 2858715 ⤷  Sign Up
Mexico 2014014788 CONTROL DE CORRIENTE PARA ADMINISTRACION DE FARMACOS POR ELECTROTRANSPORTE. (CURRENT CONTROL FOR ELECTROTRANSPORT DRUG DELIVERY.) ⤷  Sign Up
Australia 2013274873 Current control for electrotransport drug delivery ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FENTANYL HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1769785 C300522 Netherlands ⤷  Sign Up PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
0836511 122006000022 Germany ⤷  Sign Up PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
1635783 C300653 Netherlands ⤷  Sign Up 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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