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Last Updated: March 5, 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
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for fentanyl hydrochloride
Generic Entry Date for fentanyl hydrochloride*:
Constraining patent/regulatory exclusivity:
Dosage:
SYSTEM;IONTOPHORESIS, TRANSDERMAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for fentanyl hydrochloride

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

SponsorPhase
University Hospital "Sestre Milosrdnice"N/A
National Trauma CenterN/A
British Columbia Cancer AgencyPhase 2

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

International Patents for fentanyl hydrochloride

Country Patent Number Title Estimated Expiration
Russian Federation 2564084 ДВУХМОДУЛЬНОЕ УСТРОЙСТВО ЭЛЕКТРОПЕРЕНОСА (TWO-MODULE DEVICE OF ELECTROMIGRATION) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2013176728 ⤷  Try a Trial
Mexico 337312 DISPOSITIVO DE ELECTROTRANSPORTE DE DOS PARTES. (TWO-PART ELECTROTRANSPORT DEVICE.) ⤷  Try a Trial
Japan 2015517382 鎮痛剤製品用の自己試験 ⤷  Try a Trial
Russian Federation 2016152271 СХЕМА И СПОСОБ ДЛЯ ПРОВЕРКИ ПЕРЕКЛЮЧАТЕЛЯ ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for fentanyl hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0836511 CA 2006 00019 Denmark ⤷  Try a Trial PRODUCT NAME: FENTANYL HYDROCHLORID
1769785 C300522 Netherlands ⤷  Try a Trial PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
0836511 122006000022 Germany ⤷  Try a Trial PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
1769785 C300521 Netherlands ⤷  Try a Trial PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
1635783 CA 2014 00016 Denmark ⤷  Try a 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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