FENTANYL CITRATE - Generic Drug Details

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What are the generic 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:	6,178
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
Ambulance Amsterdam	Phase 3
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Phase 3
Stichting ZiektekostenVerzekering Krijgsmacht	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
Hikma	FENTANYL CITRATE	fentanyl citrate	INJECTABLE;INJECTION	019101-001	Jul 11, 1984	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cephalon	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-002	Oct 4, 1993		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
>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
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-002	Jun 30, 2011	⤷ Sign Up	⤷ Sign Up
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-005	Jan 7, 2011	⤷ Sign Up	⤷ Sign Up
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-002	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
South Korea	101329496		⤷ Sign Up
Poland	377823	Kompozycje farmaceutyczne (Pharmaceutical compositions)	⤷ Sign Up
Israel	220722	שימוש בפנטניל להכנת תכשיר רוקחי להקלה מהירה לכאב מתפרץ והתקן מתכלה ביולוגית למתן דרך הרירית המתאים למתן ישיר דרך הרירית של פנטיל (Use of fentanyl in the preparation of a pharmaceutical composition for providing rapid onset of relief from breakthrough pain and a mucoadhesive bioerodable drug delivery device suitable for direct transmucosal administration of fentanyl)	⤷ 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	300653	Netherlands	⤷ Sign Up	PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0836511	122006000022	Germany	⤷ Sign Up	PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
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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