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. Eleven 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: | 64 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 31 |
| Clinical Trials: | 12 |
| Patent Applications: | 4,507 |
| 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 | |||
| >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 | 021947-004 | Sep 25, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-004 | Sep 25, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947-003 | Sep 25, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| Portugal | 1708686 | ⤷ Try a Trial | |
| Germany | 60032691 | ⤷ Try a Trial | |
| Japan | 2007517054 | ⤷ 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 |
|---|---|---|---|---|
| 0836511 | SPC/GB06/022 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124 |
| 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 |
| 0836511 | CA 2006 00019 | Denmark | ⤷ Try a Trial | PRODUCT NAME: FENTANYL HYDROCHLORID |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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