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-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 11^th, 1984.

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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:	3,237
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

Drug patent expirations by year for FENTORA

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

See all FENTORA clinical trials

Pharmacology for FENTORA

Drug Class	Opioid Agonist
Mechanism of Action	Full 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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Effervescent oral opiate dosage forms and methods of administering opiates
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Generally linear effervescent oral fentanyl dosage form and methods of administering
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Effervescent oral fentanyl dosage form and methods of administering fentanyl
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Glossary

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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		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-005	Sep 25, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-003	Sep 25, 2006	⤷ Sign Up	⤷ Sign Up
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-002	Sep 25, 2006	⤷ Sign Up	⤷ Sign Up
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-006	Mar 2, 2007	⤷ Sign Up	⤷ Sign Up
Cephalon	FENTORA	fentanyl citrate	TABLET;BUCCAL, SUBLINGUAL	021947-001	Sep 25, 2006	⤷ Sign Up	⤷ Sign Up
>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.

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Country	Patent Number	Title	Estimated Expiration
Norway	20063430		⤷ Sign Up
European Patent Office	1417959	Comprime pour une administration buccale, sublinguale ou gingivale, comprenant un couple effervescent (Tablet for buccal, sublingual or gingival administration, comprising an effervescent couple)	⤷ Sign Up
Mexico	PA06007453	FORMA DE DOSIFICACION DE OPIACEO ORAL EFERVESCENTE. (EFFERVESCENT ORAL OPIATE DOSAGE FORM.)	⤷ Sign Up
Japan	4954170		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for FENTORA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1635783	300653	Netherlands	⤷ Sign Up	PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0836511	122006000022	Germany	⤷ Sign Up	PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
1635783	C300653	Netherlands	⤷ Sign Up	PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0975367	122011000009	Germany	⤷ Sign Up	PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description