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Fentanyl citrate - Generic Drug Details

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What are the generic 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.

Fentanyl citrate has three hundred and fifty-seven patent family members in forty-one countries.

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

Summary for fentanyl citrate

International Patents:	357
US Patents:	20
Tradenames:	9
Applicants:	13
NDAs:	18
Drug Master File Entries:	31
Suppliers / Packagers:	15
Bulk Api Vendors:	26
Clinical Trials:	60
Patent Applications:	3,028
Formulation / Manufacturing:	see details
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
Bdsi	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-003	Jul 16, 2009		DISCN	No	No
Elefsee Pharms Intl	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-001	Jun 30, 2011		RX	Yes	No			Y
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-003	Sep 25, 2006		RX	Yes	Yes			Y
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-003	Sep 25, 2006		RX	Yes	Yes			Y

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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	020747-004	Nov 4, 1998
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-006	Nov 4, 1998
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-002	Nov 4, 1998
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-004	Nov 4, 1998

Non-Orange Book US Patents for fentanyl citrate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
5,800,832	Bioerodable film for delivery of pharmaceutical compounds to mucosal surfaces
6,159,498	Bioerodable film for delivery of pharmaceutical compounds of mucosal surfaces
8,147,866	Transmucosal delivery devices with enhanced uptake
9,655,843	Transmucosal delivery devices with enhanced uptake

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International Patents for fentanyl citrate

Country	Document Number	Estimated Expiration
Canada	2335566
Spain	2507579
Australia	4019400
South Korea	101329496

Supplementary Protection Certificates for fentanyl citrate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00521	Netherlands		PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
636	Luxembourg		PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2011000009	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 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