You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Moodys
McKinsey
Dow
AstraZeneca
Merck
Colorcon

Last Updated: October 23, 2020

DrugPatentWatch Database Preview

Fentanyl - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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

Fentanyl is the generic ingredient in twenty-five branded drugs marketed by Janssen Pharms, 3m Drug Delivery, Actavis Labs Ut Inc, Aveva, Lavipharm Labs, Mayne Pharma, Mylan Technologies, Noven, Specgx Llc, Btcp Pharma, Bdsi, Abbott, Fresenius Kabi Usa, Hospira, Watson Labs, Dr Reddys, Hikma, Akorn, Cephalon, Sentynl Theraps Inc, Actavis Labs Fl Inc, Par Pharm, and The Medicines Co, and is included in thirty-one NDAs. There are thirty patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fentanyl has thirty-one patent family members in seventeen countries.

There are thirty-one drug master file entries for fentanyl. Ten suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for fentanyl

See drug prices for fentanyl

Drug Sales Revenue Trends for fentanyl

See drug sales revenues for fentanyl

Recent Clinical Trials for fentanyl

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

SponsorPhase
Helse FonnaPhase 4
Children's Hospital of Fudan UniversityPhase 4
Universiti Sains MalaysiaPhase 2

See all fentanyl clinical trials

Generic filers with tentative approvals for FENTANYL
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial100MCGTABLET;BUCCAL
  Start Trial  Start Trial800MCGTABLET;BUCCAL
  Start Trial  Start Trial600MCGTABLET;BUCCAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for fentanyl
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for fentanyl
Paragraph IV (Patent) Challenges for FENTANYL
Tradename Dosage Ingredient NDA Submissiondate
SUBSYS SPRAY;SUBLINGUAL fentanyl 202788 2017-12-07
SUBSYS SPRAY;SUBLINGUAL fentanyl 202788 2017-05-22
DURAGESIC-100 FILM, EXTENDED RELEASE;TRANSDERMAL fentanyl 019813
DURAGESIC-50 FILM, EXTENDED RELEASE;TRANSDERMAL fentanyl 019813
DURAGESIC-12 FILM, EXTENDED RELEASE;TRANSDERMAL fentanyl 019813
DURAGESIC-75 FILM, EXTENDED RELEASE;TRANSDERMAL fentanyl 019813
DURAGESIC-25 FILM, EXTENDED RELEASE;TRANSDERMAL fentanyl 019813
DURAGESIC-37 FILM, EXTENDED RELEASE;TRANSDERMAL fentanyl 019813

US Patents and Regulatory Information for fentanyl

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
Cephalon FENTANYL fentanyl citrate TROCHE/LOZENGE;ORAL 020195-001 Oct 4, 1993 DISCN No No   Start Trial   Start Trial   Start Trial
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-005 Jan 4, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-001 Jan 4, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-001 Jan 4, 2012 RX 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms DURAGESIC-100 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-001 Aug 7, 1990   Start Trial   Start Trial
Janssen Pharms DURAGESIC-75 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-002 Aug 7, 1990   Start Trial   Start Trial
Janssen Pharms DURAGESIC-50 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-003 Aug 7, 1990   Start Trial   Start Trial
Janssen Pharms DURAGESIC-75 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-002 Aug 7, 1990   Start Trial   Start Trial
Janssen Pharms DURAGESIC-25 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-004 Aug 7, 1990   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for fentanyl

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0975367 122011000009 Germany   Start Trial PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
0836511 122006000022 Germany   Start Trial PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
0836511 CA 2006 00019 Denmark   Start Trial PRODUCT NAME: FENTANYL HYDROCHLORID
1635783 122014000024 Germany   Start Trial PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
1769785 C300522 Netherlands   Start Trial PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
Colorcon
AstraZeneca
Harvard Business School
Moodys
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.