DrugPatentWatch Database Preview

Fentanyl - Generic Drug Details

« Back to Dashboard

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, 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 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-one patent family members in seventeen countries.

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

Summary for fentanyl

International Patents:	31
US Patents:	29
Tradenames:	25
Applicants:	23
NDAs:	31
Drug Master File Entries:	31
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	1,329
Patent Applications:	7,490
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for fentanyl
Drug Sales Revenues:	Drug sales revenues 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 of Calgary	Phase 2/Phase 3
Southeast University, China	Phase 3
YingHsuanTai	N/A

See all fentanyl clinical trials

Generic filers with tentative approvals for FENTANYL

Applicant	Application No.	Strength	Dosage Form
		800MCG	TABLET;BUCCAL
		600MCG	TABLET;BUCCAL
		400MCG	TABLET;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 Action	Full Opioid Agonists

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	NDA	Submissiondate
SUBSYS	SPRAY;SUBLINGUAL	fentanyl	202788	2017-12-07
SUBSYS	SPRAY;SUBLINGUAL	fentanyl	202788	2017-05-22
DURAGESIC-75	FILM, EXTENDED RELEASE;TRANSDERMAL	fentanyl	019813
DURAGESIC-25	FILM, EXTENDED RELEASE;TRANSDERMAL	fentanyl	019813
DURAGESIC-37	FILM, EXTENDED RELEASE;TRANSDERMAL	fentanyl	019813
DURAGESIC-100	FILM, EXTENDED RELEASE;TRANSDERMAL	fentanyl	019813
DURAGESIC-50	FILM, EXTENDED RELEASE;TRANSDERMAL	fentanyl	019813
DURAGESIC-12	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
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-003	Sep 25, 2006		RX	Yes	Yes			Y
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-002	Nov 4, 1998	AB	RX	Yes	Yes
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-005	Jan 4, 2012		RX	Yes	No			Y
Hospira	FENTANYL CITRATE PRESERVATIVE FREE	fentanyl citrate	INJECTABLE;INJECTION	072786-001	Sep 24, 1991	AP	RX	No	No
Mylan Technologies	FENTANYL-37	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	076258-006	Dec 29, 2014	AB	RX	No	No

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
Janssen Pharms	DURAGESIC-50	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-003	Aug 7, 1990
Janssen Pharms	DURAGESIC-50	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-003	Aug 7, 1990
Janssen Pharms	DURAGESIC-50	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-003	Aug 7, 1990
Janssen Pharms	DURAGESIC-25	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	019813-004	Aug 7, 1990

International Patents for fentanyl

Country	Patent Number	Estimated Expiration
Slovenia	1976521
Canada	2698749
Japan	2013056928
Cyprus	1117263
Australia	2008282743

Supplementary Protection Certificates for fentanyl

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1635783	CA 2014 00016	Denmark		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
1635783	300653	Netherlands		PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0836511	SPC/GB06/022	United Kingdom		PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
1769785	C300522	Netherlands		PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
0975367	122011000009	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831