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Last Updated: July 5, 2020

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

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

Drug Prices for fentanyl citrate

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Recent Clinical Trials for fentanyl citrate

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SponsorPhase
Tribhuvan University Teaching Hospital, Institute Of Medicine.Phase 4
Keith M. Vogt, MD, PhDPhase 4
McGill UniversityPhase 2/Phase 3

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Pharmacology for fentanyl citrate
Drug ClassOpioid Agonist
Mechanism of ActionFull 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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs FENTANYL CITRATE fentanyl citrate INJECTABLE;INJECTION 073488-001 Jun 30, 1992 DISCN No No   Start Trial   Start Trial   Start Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-006 Jan 7, 2011 DISCN Yes No   Start Trial   Start Trial   Start Trial
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-001 Sep 25, 2006 RX Yes No   Start Trial   Start Trial Y   Start Trial
Btcp Pharma LAZANDA fentanyl citrate SPRAY, METERED;NASAL 022569-001 Jun 30, 2011 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-004 Jan 7, 2011 DISCN Yes No   Start Trial   Start Trial   Start Trial
Btcp Pharma LAZANDA fentanyl citrate SPRAY, METERED;NASAL 022569-001 Jun 30, 2011 RX Yes No   Start Trial   Start Trial Y   Start 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
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-003 Jan 7, 2011   Start Trial   Start Trial
Sentynl Theraps Inc ABSTRAL fentanyl citrate TABLET;SUBLINGUAL 022510-001 Jan 7, 2011   Start Trial   Start Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-003 Nov 4, 1998   Start Trial   Start Trial
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-004 Sep 25, 2006   Start Trial   Start Trial
Cephalon FENTANYL fentanyl citrate TROCHE/LOZENGE;ORAL 020195-007 Oct 30, 1995   Start Trial   Start Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-001 Nov 4, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for fentanyl citrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1635783 122014000024 Germany   Start Trial PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
0901368 C300523 Netherlands   Start Trial PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
0836511 SPC/GB06/022 United Kingdom   Start Trial PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
1769785 C300522 Netherlands   Start Trial PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
0836511 122006000022 Germany   Start Trial PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
0383579 C960030 Netherlands   Start Trial PRODUCT NAME: REMIFENTANYLUM, DESGEWENST IN DE VORM VAN EEN ZUURADDITIE-ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20601 - RVG 20603 19961015; 36335.00.00, 36335.01.00, 36335.02.00 19960517
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Mallinckrodt
Boehringer Ingelheim
Dow
Colorcon

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