Fentanyl citrate - Generic Drug Details

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

Fentanyl citrate is the generic ingredient in nine branded drugs marketed by Adalvo, Abbott, Fresenius Kabi Usa, Hikma, Hospira, Watson Labs, Dr Reddys, Rising, Exela Pharma, Btcp Pharma, Dr Reddys Labs Sa, Cephalon, Sentynl Theraps Inc, Actavis Labs Fl Inc, Par Pharm, and Specgx Llc, and is included in twenty-two NDAs. There are ten patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fentanyl citrate has one hundred and seventy-two patent family members in thirty-five countries.

There are fifteen drug master file entries for fentanyl citrate. Ten suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for fentanyl citrate

International Patents:	172
US Patents:	10
Tradenames:	9
Applicants:	16
NDAs:	22
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	105
Patent Applications:	6,178
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for fentanyl citrate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fentanyl citrate
What excipients (inactive ingredients) are in fentanyl citrate?	fentanyl citrate excipients list
DailyMed Link:	fentanyl citrate at DailyMed

See drug prices for fentanyl citrate

Recent Clinical Trials for fentanyl citrate

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

Sponsor	Phase
University of British Columbia	Phase 4
Chung-Ang University Gwangmyeong Hospital	N/A
Ciusss de L'Est de l'Île de Montréal	N/A

See all fentanyl citrate clinical trials

Generic filers with tentative approvals for FENTANYL CITRATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	EQ 0.05MG BASE/ML	INJECTABLE;INJECTION

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 citrate

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for fentanyl citrate

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 CITRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ABSTRAL	Sublingual Tablets	fentanyl citrate	0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg	022510	1	2014-06-19
FENTORA	Buccal Tablets	fentanyl citrate	0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg	021947	1	2007-11-13
ACTIQ	Lozenges	fentanyl citrate	0.6 mg	020747		2004-12-20
ACTIQ	Lozenges	fentanyl citrate	0.8 mg, 1.2 mg and 1.6 mg	020747		2004-11-22
ACTIQ	Lozenges	fentanyl citrate	0.2 mg	020747		2004-10-29
ACTIQ	Lozenges	fentanyl citrate	0.4 mg	020747		2004-10-06

US Patents and Regulatory Information for fentanyl citrate

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	FENTANYL CITRATE PRESERVATIVE FREE	fentanyl citrate	INJECTABLE;INJECTION	210762-001	May 3, 2019	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Specgx Llc	FENTANYL CITRATE	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	078907-003	Oct 30, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Par Pharm	FENTANYL CITRATE	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	077312-006	Oct 30, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-005	Sep 25, 2006		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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 citrate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-003	Sep 25, 2006	⤷ Sign Up	⤷ Sign Up
Cephalon	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-001	Oct 4, 1993	⤷ Sign Up	⤷ Sign Up
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-005	Sep 25, 2006	⤷ Sign Up	⤷ Sign Up
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-003	Nov 4, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for fentanyl citrate

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Country	Patent Number	Title	Estimated Expiration
Serbia	55199	POBOLJŠANA POSUDA (IMPROVED CONTAINER)	⤷ Sign Up
China	1723012	Pharmaceutical compositions comprising fentanyl for intranasal delivery	⤷ Sign Up
Japan	2009544619		⤷ Sign Up
Hungary	E027395		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for fentanyl citrate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1769785	C300522	Netherlands	⤷ Sign Up	PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
1635783	122014000024	Germany	⤷ Sign Up	PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
1635783	C300653	Netherlands	⤷ Sign Up	PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0836511	CA 2006 00019	Denmark	⤷ Sign Up	PRODUCT NAME: FENTANYL HYDROCHLORID
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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