FENTANYL Drug Patent Profile

✉ Email this page to a colleague

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

Drug patent expirations by year 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
University of British Columbia	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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or 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
Zydus Pharms	FENTANYL-25	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	209655-002	Jan 24, 2023		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Pharms	FENTANYL-87	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	209655-007	Jan 24, 2023		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Specgx Llc	FENTANYL CITRATE	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	078907-005	Oct 30, 2009		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Par Pharm	FENTANYL CITRATE	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	077312-002	Oct 30, 2009		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aveva	FENTANYL-62	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	077449-007	Dec 6, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hospira	FENTANYL CITRATE PRESERVATIVE FREE	fentanyl citrate	INJECTABLE;INJECTION	072786-001	Sep 24, 1991	AP	RX	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

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-002	Oct 4, 1993	⤷ Try a Trial	⤷ Try a Trial
Cephalon	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-003	Oct 4, 1993	⤷ Try a Trial	⤷ Try a Trial
Cephalon	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-007	Oct 30, 1995	⤷ Try a Trial	⤷ Try a Trial
Cephalon	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-001	Oct 4, 1993	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for FENTANYL

Subscribe to access the full database, or Try a Trial
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
Janssen-Cilag International NV	Ionsys	fentanyl	EMEA/H/C/000612 Management of acute moderate to severe post-operative pain for use in a hospital setting only	Withdrawn	no	no	no	2006-01-24	2008-07-25
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for FENTANYL

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

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9103271		⤷ Try a Trial
Australia	6337190		⤷ Try a Trial
European Patent Office	0200490	COMPOSITIONS FOR NONINVASIVE ADMINISTRATION OF SEDATIVES, ANALGESICS, AND ANESTHETICS	⤷ Try a Trial
Norway	920856		⤷ Try a Trial
Japan	2717024		⤷ Try a Trial
Germany	69023143		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for FENTANYL

Subscribe to access the full database, or Try a Trial
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1635783	122014000024	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
1769785	C300521	Netherlands	⤷ Try a Trial	PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
0383579	C960030	Netherlands	⤷ Try a Trial	PRODUCT NAME: REMIFENTANYLUM, DESGEWENST IN DE VORM VAN EEN ZUURADDITIE-ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20601 - RVG 20603 19961015; 36335.00.00, 36335.01.00, 36335.02.00 19960517
0836511	CA 2006 00019	Denmark	⤷ Try a Trial	PRODUCT NAME: FENTANYL HYDROCHLORID
0901368	C300523	Netherlands	⤷ Try a Trial	PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
0836511	122006000022	Germany	⤷ Try a Trial	PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Summary for FENTANYL

Recent Clinical Trials for FENTANYL

Medical Subject Heading (MeSH) Categories for FENTANYL

Anatomical Therapeutic Chemical (ATC) Classes for FENTANYL

Paragraph IV (Patent) Challenges for FENTANYL

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