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Last Updated: October 27, 2021

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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, 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.

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
Baylor College of MedicineEarly Phase 1
University of ArkansasPhase 2
University of AlexandriaN/A

See all fentanyl citrate clinical trials

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
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-004 Sep 25, 2006 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-001 Sep 25, 2006 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  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
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-001 Sep 25, 2006 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Bdsi ONSOLIS fentanyl citrate FILM;BUCCAL 022266-003 Jul 16, 2009 DISCN No 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

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

Supplementary Protection Certificates for fentanyl citrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0901368 C300523 Netherlands ⤷  Try it Free PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
1635783 132014902242643 Italy ⤷  Try it Free 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
1635783 CA 2014 00016 Denmark ⤷  Try it Free 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 ⤷  Try it Free PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
1635783 122014000024 Germany ⤷  Try it Free 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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Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Mallinckrodt
Boehringer Ingelheim
Dow
Colorcon

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