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Last Updated: June 22, 2021

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FENTORA Drug 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. Nine suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

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
Augusta UniversityPhase 4
CephalonPhase 4
Massachusetts General HospitalPhase 1/Phase 2

See all FENTORA clinical trials

Pharmacology for FENTORA
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Paragraph IV (Patent) Challenges for FENTORA
Tradename Dosage Ingredient NDA Submissiondate
FENTORA TABLET;BUCCAL, SUBLINGUAL fentanyl citrate 021947 2007-11-13

US Patents and Regulatory Information for FENTORA

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   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-005 Sep 25, 2006 RX Yes No   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-002 Sep 25, 2006 RX Yes No   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
>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 021947-001 Sep 25, 2006   Try Before You Buy   Try Before You Buy
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-004 Sep 25, 2006   Try Before You Buy   Try Before You Buy
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-005 Sep 25, 2006   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for FENTORA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1635783 300653 Netherlands   Try Before You Buy PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0975367 122011000009 Germany   Try Before You Buy PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
0901368 C300523 Netherlands   Try Before You Buy PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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