Fentora Drug Patent Profile
✉ Email this page to a colleague
When do Fentora patents expire, and what generic alternatives are available?
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 |
---|---|
M.D. Anderson Cancer Center | Phase 3 |
National Cancer Institute (NCI) | 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 |
---|---|---|---|
Spain | 2359979 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2005065319 | ⤷ Try a Trial | |
Croatia | P20110336 | ⤷ Try a Trial | |
Israel | 176452 | צורת מינון תוססת למתן דרך הפה של אופיאט ושימושה להכנת תרופה (Effervescent oral opiate dosage form and use thereof for preparation of a medicament) | ⤷ Try a Trial |
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) | ⤷ Try a Trial |
Norway | 20063430 | ⤷ Try a Trial | |
Germany | 602004031462 | ⤷ 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 | 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 |
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 |
0836511 | 122006000022 | Germany | ⤷ Try a Trial | PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126 |
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 | CA 2006 00019 | Denmark | ⤷ Try a Trial | PRODUCT NAME: FENTANYL HYDROCHLORID |
1769785 | C300521 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006 |
0901368 | C300523 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |