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Last Updated: November 2, 2024

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.

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
Stichting ZiektekostenVerzekering KrijgsmachtPhase 3
Ambulance AmsterdamPhase 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 UpEQ 0.05MG BASE/MLINJECTABLE;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 ClassOpioid 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
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-001 Nov 4, 1998 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
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
Rising SUBLIMAZE PRESERVATIVE FREE fentanyl citrate INJECTABLE;INJECTION 016619-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys Labs Sa FENTANYL CITRATE fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 206329-003 Aug 22, 2022 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Watson Labs FENTANYL CITRATE fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 079075-001 Jan 7, 2011 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Btcp Pharma LAZANDA fentanyl citrate SPRAY, METERED;NASAL 022569-001 Jun 30, 2011 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-005 Sep 25, 2006 ⤷  Sign Up ⤷  Sign Up
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-002 Jan 7, 2011 ⤷  Sign Up ⤷  Sign Up
Adalvo ONSOLIS fentanyl citrate FILM;BUCCAL 022266-002 Jul 16, 2009 ⤷  Sign Up ⤷  Sign Up
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-004 Jan 7, 2011 ⤷  Sign Up ⤷  Sign Up
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-001 Jan 7, 2011 ⤷  Sign Up ⤷  Sign Up
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-003 Jan 7, 2011 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for FENTANYL CITRATE

Country Patent Number Title Estimated Expiration
Brazil 122020000250 dispositivos para administração de fármaco ⤷  Sign Up
China 1723012 Pharmaceutical compositions comprising fentanyl for intranasal delivery ⤷  Sign Up
Poland 212950 ⤷  Sign Up
Japan 2013151549 TRANSMUCOSAL DELIVERY DEVICE WITH ENHANCED UPTAKE ⤷  Sign Up
Japan 2009544619 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2008011194 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FENTANYL CITRATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0836511 122006000022 Germany ⤷  Sign Up PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
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 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
0975367 122011000009 Germany ⤷  Sign Up PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
0836511 SPC/GB06/022 United Kingdom ⤷  Sign Up PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
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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