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Last Updated: February 22, 2024

Fentanyl - Generic Drug Details


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What are the generic drug sources for fentanyl and what is the scope of patent protection?

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, Zydus Pharms, Btcp Pharma, Adalvo, Abbott, Fresenius Kabi Usa, Hikma, Hospira, Watson Labs, Dr Reddys, Rising, Exela Pharma, Dr Reddys Labs Sa, Cephalon, Sentynl Theraps Inc, Actavis Labs Fl Inc, Par Pharm, and The Medicines Co, and is included in thirty-four NDAs. There are twenty-eight 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 are two tentative approvals for this compound.

Drug Prices for fentanyl

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Drug Sales Revenue Trends for fentanyl

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Recent Clinical Trials for fentanyl

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 clinical trials

Generic filers with tentative approvals for FENTANYL
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a TrialEQ 0.05MG BASE/MLINJECTABLE;INJECTION
⤷  Try a Trial⤷  Try a Trial800MCGTABLET;BUCCAL
⤷  Try a Trial⤷  Try a 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 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
Specgx Llc FENTANYL-37 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 077154-006 Jan 14, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Btcp Pharma LAZANDA fentanyl citrate SPRAY, METERED;NASAL 022569-001 Jun 30, 2011 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms FENTANYL-50 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 209655-004 Jan 24, 2023 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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

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 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms DURAGESIC-25 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-004 Aug 7, 1990 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms DURAGESIC-50 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-003 Aug 7, 1990 ⤷  Try a Trial ⤷  Try a Trial
>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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for fentanyl

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

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