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Last Updated: December 7, 2022

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 nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fentanyl hydrochloride has one hundred and twenty-two patent family members in thirty countries.

There are two drug master file entries for fentanyl hydrochloride.

Summary for fentanyl hydrochloride
Recent Clinical Trials for fentanyl hydrochloride

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

SponsorPhase
Eskisehir Osmangazi UniversityN/A
Sahlgrenska University Hospital, SwedenPhase 4
Lee's Pharmaceutical LimitedPhase 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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 See Plans and Pricing See Plans and Pricing
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for fentanyl hydrochloride

Country Patent Number Title Estimated Expiration
European Patent Office 2691148 DISPOSITIF DE TRANSPORT D'ÉLECTRONS CONSTITUÉ DE DEUX PARTIES (TWO-PART ELECTROTRANSPORT DEVICE) See Plans and Pricing
Russian Federation 2564084 ДВУХМОДУЛЬНОЕ УСТРОЙСТВО ЭЛЕКТРОПЕРЕНОСА (TWO-MODULE DEVICE OF ELECTROMIGRATION) See Plans and Pricing
Australia 2015271708 Switch validation circuit and method See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for fentanyl hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0383579 C960030 Netherlands See Plans and Pricing 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
0836511 122006000022 Germany See Plans and Pricing PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
1635783 300653 Netherlands See Plans and Pricing 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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Serving leading biopharmaceutical companies globally:

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