DrugPatentWatch Database Preview

Fentanyl citrate - Generic Drug Details

« Back to Dashboard

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

Fentanyl citrate is the generic ingredient in nine branded drugs marketed by Bdsi, Abbott, Hospira, Watson Labs, Watson Labs Inc, West-ward Pharms Int, Akorn, Elefsee Pharms Intl, Cephalon, Sentynl Theraps Inc, Actavis Labs Fl Inc, Par Pharm, and Specgx Llc, and is included in eighteen NDAs. There are twenty patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are thirty-one drug master file entries for fentanyl citrate. Fifteen suppliers are listed for this compound.

Summary for fentanyl citrate

US Patents:	20
Tradenames:	9
Applicants:	13
NDAs:	18
Drug Master File Entries:	31
Suppliers / Packagers:	15
Bulk Api Vendors:	27
Clinical Trials:	63
Patent Applications:	3,092
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for fentanyl citrate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fentanyl citrate
DailyMed Link:	fentanyl citrate at DailyMed

Pharmacology for fentanyl citrate

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Synonyms for fentanyl citrate

2-hydroxypropane-1,2,3-tricarboxylic acid; N-(1-phenethylpiperidin-4-yl)-N-phenylpropanamide

437-38-7 (Parent)

990-73-8

990F738

Abstral (TN)

AC1L22J8

AC1Q5SOC

AKOS024457504

AN-48204

API0002694

B5403

CHEBI:31602

CHEMBL688

CITRIC ACID; FENTANYL

citric acid; N-phenyl-N-[1-(2-phenylethyl)-4-piperidyl]propanamide

D01399

DTXSID80243933

EINECS 213-588-0

Fentanyl citrate (JP17/USP)

Fentanyl citrate [USAN:JAN]

Fentanyl citrate [USAN:USP:BAN:JAN]

FENTANYL CITRATE PRESERVATIVE FREE

Fentanyl citrate salt

Fentanyl citrate salt solution, drug standard, 100 mug/mL in methanol: tert-butanol (3:2)

Fentanyl citrate, United States Pharmacopeia (USP) Reference Standard

Fentanyl dihydrogen citrate

fentanyl monocitrate

Fentanylcitrate

Fentaz

Fentora (TN)

FT-0668509

HE071150

IVLVTNPOHDFFCJ-UHFFFAOYSA-N

Lazanda (TN)

Leptanol

LS-124441

McN-JR 4263

McN-JR-4263-49

MFCD00058359

MUN5LYG46H

N-(1-Phenethyl-4-piperidinyl)propionanilide dihydrogen citrate

N-(1-Phenethyl-4-piperidyl)propionanilide citrate

N-(1-Phenethyl-4-piperidyl)propionanilide citrate (1:1)

N-(1-Phenethyl-4-piperidyl)propionanilide dihydrogen citrate

N-(1-phenethylpiperidin-4-yl)-N-phenylpropionamide citrate

N-(Phenyl)-N-(1-[2-phenylethyl]-4-piperidinyl)propanamide Citrate

N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]propanamide citrate

N-Phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]propanamide citrate salt

N-phenyl-N-[1-(2-phenylethyl)-4-piperidyl]propanamide citrate

N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]propanamide 2-hydroxypropane-1,2,3-tricarboxylate

Oralet

Oralet (TN)

Oravescent

Phentanyl citrate

Propanamide, N-phenyl-N-(1-(2-phenylethyl)-4-piperidinyl)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)

Propionanilide, N-(1-phenethyl-4-piperidyl)-, citrate (1:1)

R 5240

SCHEMBL40733

SUBLIMAZE PRESERVATIVE FREE

UNII-MUN5LYG46H

US Patents and Regulatory Information for fentanyl citrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Par Pharm	FENTANYL CITRATE	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	077312-004	Oct 30, 2009		DISCN	No	No
Hospira	FENTANYL CITRATE PRESERVATIVE FREE	fentanyl citrate	INJECTABLE;INJECTION	072786-001	Sep 24, 1991	AP	RX	No	No
Actavis Labs Fl Inc	FENTANYL CITRATE	fentanyl citrate	TABLET;SUBLINGUAL	207338-004	Nov 17, 2017	AB	RX	No	No
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-003	Nov 4, 1998	AB	RX	Yes	No
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006		RX	Yes	No			Y
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-005	Jan 7, 2011	AB	RX	Yes	No			Y
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-005	Jan 7, 2011	AB	RX	Yes	No			Y

Expired US Patents for fentanyl citrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-001	Nov 4, 1998
Bdsi	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-003	Jul 16, 2009
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-002	Nov 4, 1998
Elefsee Pharms Intl	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-002	Jun 30, 2011
Bdsi	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-001	Jul 16, 2009
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-004	Nov 4, 1998
Cephalon	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-007	Oct 30, 1995

International Patents for fentanyl citrate

Country	Document Number	Estimated Expiration
Norway	20053119
Bulgaria	105379
Spain	2592259
Cyprus	1109176
Norway	20011502
Australia	746339
Canada	2335566

Supplementary Protection Certificates for fentanyl citrate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2015000006	Germany		PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
2006000022	Germany		PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
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
2015 00004	Denmark		PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
2006 00019	Denmark		PRODUCT NAME: FENTANYL HYDROCHLORID
00522	Netherlands		PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
00714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718