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Last Updated: January 30, 2023

Fentanyl - Generic Drug Details


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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, Actavis Labs Ut Inc, Aveva, Kindeva, Lavipharm Labs, Mayne Pharma, Mylan Technologies, Noven, Specgx Llc, Btcp Pharma, Adalvo, 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-two NDAs. There are twenty-nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are thirty-one drug master file entries for fentanyl. Seven 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
McMaster Children's HospitalPhase 4
Icahn School of Medicine at Mount SinaiPhase 3
Bicycle HealthPhase 4

See all fentanyl clinical trials

Generic filers with tentative approvals for FENTANYL
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing400MCGTABLET;BUCCAL
See Plans and PricingSee Plans and Pricing300MCGTABLET;BUCCAL
See Plans and PricingSee Plans and Pricing200MCGTABLET;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 Class Opioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for fentanyl
Paragraph IV (Patent) Challenges for FENTANYL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SUBSYS Sublingual Spray fentanyl 0.1 mg/spray, 0.2 mg/spray, 0.6 mg/spray, 0.8 mg/spray, 1.2 mg/spray, 1.6 mg/spray 202788 1 2017-12-07
SUBSYS Sublingual Spray fentanyl 0.4 mg/spray 202788 1 2017-05-22

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
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-001 Sep 25, 2006 RX 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
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-005 Sep 25, 2006 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-007 Aug 30, 2012 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Specgx Llc FENTANYL-12 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 077154-005 Jun 11, 2015 AB RX No No See Plans and Pricing See Plans and Pricing 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

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

EU/EMA Drug Approvals for fentanyl

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Kyowa Kirin Holdings B.V. PecFent fentanyl EMEA/H/C/001164
PecFent is indicated for the management of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain., , Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equi-analgesic dose of another opioid for a week or longer.,
Authorised no no no 2010-08-31
Takeda Pharma A/S Instanyl fentanyl EMEA/H/C/000959
Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Authorised no no no 2009-07-20
Teva B.V. Effentora fentanyl EMEA/H/C/000833
Effentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain., , BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain., , Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer. ,
Authorised no no no 2008-04-04
Incline Therapeutics Europe Ltd Ionsys fentanyl EMEA/H/C/002715
Ionsys is indicated for the management of acute moderate to severe post-operative pain in adult patients.
Withdrawn no no no 2015-11-18
Eli Lilly and Company Limited  Recuvyra fentanyl EMEA/V/C/002239
For the control of pain associated with orthopaedic and soft tissue surgery in dogs.
Withdrawn no no no 2011-10-06
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for fentanyl

Country Patent Number Title Estimated Expiration
Japan 2013056928 SUBLINGUAL FENTANYL SPRAY See Plans and Pricing
Russian Federation 2008130763 СУБЛИНГВАЛЬНЫЙ АЭРОЗОЛЬ НА ОСНОВЕ ФЕНТАНИЛА See Plans and Pricing
Slovenia 1976521 See Plans and Pricing
Spain 2668366 See Plans and Pricing
Brazil PI0707235 formulação de fentanil sublingual, dose unitária de uma formulação de fentanil sublingual, métodos para tratar dor e para tratar a manifestação súbita da dor, dispositivos de dose unitária ou dose dupla e de dose múltipla para a administração sublingual de um medicamento, método para preparar uma composição farmacêutica para a administração sublingual, formulação farmacêutica sublingual, dose unitária de uma formulação farmacêutica sublingual, e, método para tratar um paciente humano See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for fentanyl

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0901368 C300523 Netherlands See Plans and Pricing PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
0836511 CA 2006 00019 Denmark See Plans and Pricing PRODUCT NAME: FENTANYL HYDROCHLORID
1635783 CA 2014 00016 Denmark See Plans and Pricing 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
0975367 122011000009 Germany See Plans and Pricing PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
1769785 C300522 Netherlands See Plans and Pricing 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

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