FENTORA Drug Patent Profile
✉ Email this page to a colleague
When do Fentora patents expire, 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-six 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. Ten 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 HIKMA on July 11th, 1984.
Summary for FENTORA
International Patents: | 66 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 38 |
Clinical Trials: | 12 |
Patent Applications: | 3,127 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for FENTORA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FENTORA |
What excipients (inactive ingredients) are in FENTORA? | FENTORA excipients list |
DailyMed Link: | FENTORA at DailyMed |
Recent Clinical Trials for FENTORA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Cancer Institute (NCI) | Phase 3 |
M.D. Anderson Cancer Center | Phase 3 |
Augusta University | Phase 4 |
Pharmacology for FENTORA
Drug Class | Opioid Agonist |
Mechanism of Action | Full Opioid Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for FENTORA
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Effervescent oral opiate dosage forms and methods of administering opiates
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Generally linear effervescent oral fentanyl dosage form and methods of administering
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Effervescent oral fentanyl dosage form and methods of administering fentanyl
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-001 | Sep 25, 2006 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 | |||
Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-002 | Sep 25, 2006 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-002 | Sep 25, 2006 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-003 | Sep 25, 2006 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 | |||
Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-006 | Mar 2, 2007 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 FENTORA
International Patents for FENTORA
See the table below for patents covering FENTORA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Cyprus | 1109172 | ⤷ Try a Trial | |
South Africa | 200606172 | Generally linear effervescent oral fentanyl dosage form and methods of adminstering | ⤷ Try a Trial |
Germany | 60042463 | ⤷ Try a Trial | |
South Korea | 20060127944 | GENERALLY LINEAR EFFERVESCENT ORAL FENTANYL DOSAGE FORM AND METHODS OF ADMINISTERING | ⤷ Try a Trial |
Hong Kong | 1130691 | ⤷ Try a Trial | |
European Patent Office | 1708685 | FORMES GALENIQUES D'OPIATES ORALES EFFERVESCENTES ET PROCEDES D'ADMINISTRATION DE L'OXYCODONE (EFFERVESCENT ORAL OPIATE DOSAGE FORMS AND METHODS OF ADMINISTERING OXYCODONE) | ⤷ Try a Trial |
Austria | E500821 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FENTORA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1635783 | 122014000024 | Germany | ⤷ Try a Trial | PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831 |
0836511 | 122006000022 | Germany | ⤷ Try a Trial | PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126 |
0836511 | CA 2006 00019 | Denmark | ⤷ Try a Trial | PRODUCT NAME: FENTANYL HYDROCHLORID |
0975367 | 122011000009 | Germany | ⤷ Try a Trial | PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831 |
1635783 | C300653 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906 |
1635783 | 300653 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906 |
1769785 | C300522 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |