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Last Updated: March 5, 2024

Fentanyl citrate - Generic Drug Details


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What are the generic sources for fentanyl citrate and what is the scope of freedom to operate?

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
University of British ColumbiaPhase 4
Chung-Ang University Gwangmyeong HospitalN/A
Ciusss de L'Est de l'Île de MontréalN/A

See all fentanyl citrate clinical trials

Generic filers with tentative approvals for FENTANYL CITRATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a TrialEQ 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 020747-002 Nov 4, 1998 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-005 Sep 25, 2006 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Specgx Llc FENTANYL CITRATE fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 078907-004 Oct 30, 2009 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc FENTANYL CITRATE fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 078907-002 Oct 30, 2009 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Btcp Pharma LAZANDA fentanyl citrate SPRAY, METERED;NASAL 022569-002 Jun 30, 2011 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-004 Sep 25, 2006 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 021947-002 Sep 25, 2006 ⤷  Try a Trial ⤷  Try a Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-004 Jan 7, 2011 ⤷  Try a Trial ⤷  Try a Trial
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-005 Sep 25, 2006 ⤷  Try a Trial ⤷  Try a Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-004 Nov 4, 1998 ⤷  Try a Trial ⤷  Try a Trial
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-002 Sep 25, 2006 ⤷  Try a Trial ⤷  Try a Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-002 Nov 4, 1998 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for fentanyl citrate

Country Patent Number Title Estimated Expiration
European Patent Office 1635783 COMPOSITIONS PHARMACEUTIQUES CONTENANT DU FENTANYL POUR APPLICATION NASALE (PHARMACEUTICAL COMPOSITIONS COMPRISING FENTANYL FOR INTRANASAL DELIVERY) ⤷  Try a Trial
Japan 2014511307 ⤷  Try a Trial
Canada 2658585 DISPOSITIFS D'ADMINISTRATION TRANSMUQUEUSE AVEC ABSORPTION ACCRUE (TRANSMUCOSAL DELIVERY DEVICES WITH ENHANCED UPTAKE) ⤷  Try a Trial
Norway 20090278 ⤷  Try a Trial
Slovenia 2054031 ⤷  Try a Trial
South Africa 200606172 Generally linear effervescent oral fentanyl dosage form and methods of adminstering ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for fentanyl citrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0836511 CA 2006 00019 Denmark ⤷  Try a Trial PRODUCT NAME: FENTANYL HYDROCHLORID
1769785 C300522 Netherlands ⤷  Try a Trial PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
0836511 122006000022 Germany ⤷  Try a Trial PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
1635783 132014902242643 Italy ⤷  Try a Trial 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
1769785 C300521 Netherlands ⤷  Try a Trial PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
1635783 CA 2014 00016 Denmark ⤷  Try a Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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