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Last Updated: October 25, 2021

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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 Bdsi, Abbott, Fresenius Kabi Usa, Hospira, Watson Labs, Dr Reddys, Hikma Pharms, Akorn, Btcp Pharma, Cephalon, Sentynl Theraps Inc, Actavis Labs Fl Inc, Par Pharm, and Specgx Llc, and is included in twenty 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 patent family members in thirty-five countries.

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

Summary for fentanyl citrate

International Patents:	170
US Patents:	10
Tradenames:	9
Applicants:	14
NDAs:	20
Drug Master File Entries:	31
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	82
Patent Applications:	3,959
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
Baylor College of Medicine	Early Phase 1
University of Arkansas	Phase 2
University of Alexandria	N/A

See all fentanyl citrate clinical trials

Pharmacology for fentanyl citrate

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Paragraph IV (Patent) Challenges for FENTANYL CITRATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
ABSTRAL	TABLET;SUBLINGUAL	fentanyl citrate	022510	2014-06-19
FENTORA	TABLET;BUCCAL, SUBLINGUAL	fentanyl citrate	021947	2007-11-13
ACTIQ	TROCHE/LOZENGE;TRANSMUCOSAL	fentanyl citrate	020747	2004-12-20
ACTIQ	TROCHE/LOZENGE;TRANSMUCOSAL	fentanyl citrate	020747	2004-11-22
ACTIQ	TROCHE/LOZENGE;TRANSMUCOSAL	fentanyl citrate	020747	2004-10-29
ACTIQ	TROCHE/LOZENGE;TRANSMUCOSAL	fentanyl citrate	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	022569-002	Jun 30, 2011		RX	Yes	Yes	⤷ Try it Free	⤷ Try it Free	Y			⤷ Try it Free
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-001	Nov 4, 1998	AB	RX	Yes	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Bdsi	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-004	Jul 16, 2009		DISCN	No	No	⤷ Try it Free	⤷ Try it Free	Y			⤷ Try it Free
Akorn	SUBLIMAZE PRESERVATIVE FREE	fentanyl citrate	INJECTABLE;INJECTION	016619-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006		RX	Yes	No	⤷ Try it Free	⤷ Try it Free	Y			⤷ Try it Free
>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	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-003	Oct 4, 1993	⤷ Try it Free	⤷ Try it Free
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-002	Jan 7, 2011	⤷ Try it Free	⤷ Try it Free
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-001	Nov 4, 1998	⤷ Try it Free	⤷ Try it Free
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-004	Jan 7, 2011	⤷ Try it Free	⤷ Try it Free
Cephalon	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-007	Oct 30, 1995	⤷ Try it Free	⤷ Try it Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for fentanyl citrate

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Country	Patent Number	Estimated Expiration
Cyprus	1111458	⤷ Try it Free
Georgia, Republic of	P20084340	⤷ Try it Free
Japan	2014511307	⤷ Try it Free
Portugal	1635783	⤷ Try it Free
China	100423709	⤷ Try it Free
>Country	>Patent Number	>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	⤷ Try it Free	PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
0901368	C300523	Netherlands	⤷ Try it Free	PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
1769785	C300521	Netherlands	⤷ Try it Free	PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
0836511	SPC/GB06/022	United Kingdom	⤷ Try it Free	PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
1635783	C300653	Netherlands	⤷ Try it Free	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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.