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Last Updated: September 25, 2022

FENTORA Drug Patent Profile


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Which patents cover Fentora, and when can generic versions of Fentora launch?

Fentora is a drug marketed by Cephalon and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-four patent family members in twenty-nine countries.

The generic ingredient in FENTORA is fentanyl citrate. There are thirty-one drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Fentora

A generic version of FENTORA was approved as fentanyl citrate by HOSPIRA on January 12th, 1985.

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Drug patent expirations by year for FENTORA
Drug Prices for FENTORA

See drug prices for FENTORA

Recent Clinical Trials for FENTORA

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

SponsorPhase
M.D. Anderson Cancer CenterPhase 3
National Cancer Institute (NCI)Phase 3
Augusta UniversityPhase 4

See all FENTORA clinical trials

Pharmacology for FENTORA
Drug Class Opioid Agonist
Mechanism of ActionFull Opioid Agonists
Paragraph IV (Patent) Challenges for FENTORA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
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

US Patents and Regulatory Information for FENTORA

FENTORA is protected by four US patents.

Patents protecting FENTORA

Generally linear effervescent oral fentanyl dosage form and methods of administering
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Effervescent oral opiate dosage forms and methods of administering opiates
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Generally linear effervescent oral fentanyl dosage form and methods of administering
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Effervescent oral fentanyl dosage form and methods of administering fentanyl
Patent Number: See Plans and Pricing
Patent Expiration: 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
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-001 Sep 25, 2006 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-005 Sep 25, 2006 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-002 Sep 25, 2006 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-002 Sep 25, 2006 RX Yes No See Plans and Pricing See Plans and Pricing Y 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 FENTORA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-002 Sep 25, 2006 See Plans and Pricing See Plans and Pricing
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-003 Sep 25, 2006 See Plans and Pricing See Plans and Pricing
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-006 Mar 2, 2007 See Plans and Pricing See Plans and Pricing
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-002 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 FENTORA

See the table below for patents covering FENTORA around the world.

Country Patent Number Title Estimated Expiration
Cyprus 1111458 See Plans and Pricing
Cyprus 1109172 See Plans and Pricing
European Patent Office 1419765 Procédé pour préparer des comprimés analgétiques comprenant un couple effervescent pour une administration à travers la muqueuse orale (Process for manufacturing analgesic tablets comprising an effervescent couple for administration across the oral mucosa) See Plans and Pricing
Mexico PA06007453 FORMA DE DOSIFICACION DE OPIACEO ORAL EFERVESCENTE. (EFFERVESCENT ORAL OPIATE DOSAGE FORM.) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FENTORA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0836511 122006000022 Germany See Plans and Pricing PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
1769785 C300522 Netherlands See Plans and Pricing PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
0383579 C960030 Netherlands See Plans and Pricing 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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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