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Last Updated: January 30, 2023

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, Hospira, Watson Labs, Dr Reddys, Hikma, Akorn, Btcp Pharma, Mayne Pharma, Cephalon, Sentynl Theraps Inc, Actavis Labs Fl Inc, Par Pharm, and Specgx Llc, and is included in twenty-one 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 fifteen drug master file entries for fentanyl citrate. Ten suppliers are listed for this compound.

Drug Prices for fentanyl citrate

See drug prices for fentanyl citrate

Recent Clinical Trials for fentanyl citrate

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

SponsorPhase
United States Department of DefensePhase 3
Jason SperryPhase 3
Jean-Pierre RoutyN/A

See all fentanyl citrate clinical trials

Pharmacology for fentanyl citrate
Drug Class Opioid Agonist
Mechanism of ActionFull Opioid Agonists
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

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-005 Nov 4, 1998 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Par Pharm FENTANYL CITRATE fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 077312-003 Oct 30, 2009 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Btcp Pharma LAZANDA fentanyl citrate SPRAY, METERED;NASAL 022569-002 Jun 30, 2011 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Hikma FENTANYL CITRATE PRESERVATIVE FREE fentanyl citrate INJECTABLE;INJECTION 019101-001 Jul 11, 1984 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-001 Sep 25, 2006 See Plans and Pricing See Plans and Pricing
Adalvo ONSOLIS fentanyl citrate FILM;BUCCAL 022266-003 Jul 16, 2009 See Plans and Pricing See Plans and Pricing
Cephalon FENTANYL fentanyl citrate TROCHE/LOZENGE;ORAL 020195-007 Oct 30, 1995 See Plans and Pricing See Plans and Pricing
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-001 Sep 25, 2006 See Plans and Pricing See Plans and Pricing
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-005 Sep 25, 2006 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for fentanyl citrate

Country Patent Number Title Estimated Expiration
Spain 2577390 See Plans and Pricing
Slovenia 1635783 See Plans and Pricing
Norway 335127 See Plans and Pricing
South Africa 200606172 Generally linear effervescent oral fentanyl dosage form and methods of adminstering See Plans and Pricing
Ukraine 85050 ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ ИНТРАНАЗАЛЬНОГО ВВЕДЕНИЯ ФЕНТАНИЛА;ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ ДЛЯ ІНТРАНАЗАЛЬНОГО ВВЕДЕННЯ ФЕНТАНІЛУ (PHARMACEUTICAL COMPOSITIONS COMPRISING FENTANYL FOR INTRANASAL DELIVERY) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for fentanyl citrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1635783 132014902242643 Italy See Plans and Pricing 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
0901368 C300523 Netherlands See Plans and Pricing PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
0836511 CA 2006 00019 Denmark See Plans and Pricing PRODUCT NAME: FENTANYL HYDROCHLORID
1635783 CA 2014 00016 Denmark See Plans and Pricing 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
0975367 122011000009 Germany See Plans and Pricing PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
>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.