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:	106
Patent Applications:	6,430
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
Stichting ZiektekostenVerzekering Krijgsmacht	Phase 3
Ambulance Amsterdam	Phase 3
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Phase 3

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
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-001	Jun 30, 2011		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-003	Sep 25, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Actavis Labs Fl Inc	FENTANYL CITRATE	fentanyl citrate	TABLET;SUBLINGUAL	207338-002	Nov 17, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-001	Sep 25, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006		DISCN	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
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-002	Jan 7, 2011	⤷ Sign Up	⤷ Sign Up
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-001	Sep 25, 2006	⤷ Sign Up	⤷ Sign Up
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-001	Jan 7, 2011	⤷ Sign Up	⤷ Sign Up
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-004	Jul 16, 2009	⤷ Sign Up	⤷ Sign Up
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-004	Jan 7, 2011	⤷ 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
China	102078310	Generally linear effervescent oral fentanyl dosage form and methods of administering	⤷ Sign Up
Canada	2824385	RECIPIENT AMELIORE (IMPROVED CONTAINER)	⤷ Sign Up
Mexico	PA05007333	COMPOSICIONES FARMACEUTICAS. (PHARMACEUTICAL COMPOSITIONS COMPRISING FENTANYL FOR INTRANASAL DELIVERY.)	⤷ Sign Up
Japan	6051169		⤷ Sign Up
South Korea	20060127944	GENERALLY LINEAR EFFERVESCENT ORAL FENTANYL DOSAGE FORM AND METHODS OF ADMINISTERING	⤷ 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
1635783	CA 2014 00016	Denmark	⤷ Sign Up	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
1769785	C300521	Netherlands	⤷ Sign Up	PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
0383579	C960030	Netherlands	⤷ Sign Up	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
1635783	132014902242643	Italy	⤷ Sign Up	PRODUCT NAME: FENTANIL IN QUALSIASI FORMA PROTETTA DAL BREVETTO DI BASE(PECFENT); AUTHORISATION NUMBER(S) AND DATE(S): 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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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