FENTANYL Drug Patent Profile

Which patents cover Fentanyl, and when can generic versions of Fentanyl launch?

Fentanyl is a drug marketed by Cephalon, Abbott, Fresenius Kabi Usa, Hikma, Hospira, Watson Labs, Exela Pharma, Dr Reddys Labs Sa, Actavis Labs Fl Inc, Par Pharm, Specgx Llc, Astrazeneca, Dr Reddys, Actavis Labs Ut Inc, Aveva, Kindeva, Lavipharm Labs, Mayne Pharma, Mylan Technologies, Noven, and Zydus Pharms. and is included in twenty-nine NDAs.

The generic ingredient in FENTANYL is fentanyl. There are thirty-one drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the fentanyl profile page.

Summary for FENTANYL

US Patents:	0
Applicants:	21
NDAs:	29
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	1,624
Patent Applications:	4,515
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for FENTANYL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FENTANYL
What excipients (inactive ingredients) are in FENTANYL?	FENTANYL excipients list
DailyMed Link:	FENTANYL at DailyMed

See drug prices for FENTANYL

See drug sales revenues for FENTANYL

Recent Clinical Trials for FENTANYL

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

Sponsor	Phase
University Hospital "Sestre Milosrdnice"	N/A
National Trauma Center	N/A
British Columbia Cancer Agency	Phase 2

See all FENTANYL clinical trials

Medical Subject Heading (MeSH) Categories for FENTANYL

Adjuvants, Anesthesia

Analgesics, Opioid

Anesthetics, Intravenous

Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for FENTANYL

N01AH	Opioid anesthetics
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

N02AB	Phenylpiperidine derivatives
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

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
Zydus Pharms	FENTANYL-25	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	209655-002	Jan 24, 2023		DISCN	No	No
Zydus Pharms	FENTANYL-87	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	209655-007	Jan 24, 2023		DISCN	No	No
Specgx Llc	FENTANYL CITRATE	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	078907-005	Oct 30, 2009		DISCN	No	No

Expired US Patents for FENTANYL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-002	Oct 4, 1993
Cephalon	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-003	Oct 4, 1993
Cephalon	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-007	Oct 30, 1995

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

International Patents for FENTANYL

See the table below for patents covering FENTANYL around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	1339190	COMPOSITIONS ET METHODES DE FABRICATION DE MEDICAMENTS DANS DES POUDRES COMPRIMEES (COMPOSITIONS AND METHODS OF MANUFACTURE OF COMPRESSED POWDER MEDICAMENTS)
Australia	668004
Japan	2580076

Supplementary Protection Certificates for FENTANYL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1769785	C300521	Netherlands		PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
1769785	C300522	Netherlands		PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
1635783	300653	Netherlands		PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906