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Last Updated: November 18, 2019

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Details for New Drug Application (NDA): 021947

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NDA 021947 describes FENTORA, which is a drug marketed by Cephalon and is included in one NDA. It is available from two suppliers. There are nine patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FENTORA profile page.

The generic ingredient in FENTORA is fentanyl citrate. There are thirty-one drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.
Summary for 021947
Tradename:FENTORA
Applicant:Cephalon
Ingredient:fentanyl citrate
Patents:9
Formulation / Manufacturing:see details
Pharmacology for NDA: 021947
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 021947
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947 NDA AUTHORIZED GENERIC Mayne Pharma 51862-634 51862-634-28 28 BLISTER PACK in 1 CARTON (51862-634-28) > 1 TABLET in 1 BLISTER PACK (51862-634-01)
FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947 NDA AUTHORIZED GENERIC Mayne Pharma 51862-635 51862-635-28 28 BLISTER PACK in 1 CARTON (51862-635-28) > 1 TABLET in 1 BLISTER PACK (51862-635-01)
Paragraph IV (Patent) Challenges for 021947
Tradename Dosage Ingredient NDA Submissiondate
FENTORA TABLET;BUCCAL, SUBLINGUAL fentanyl citrate 021947 2007-11-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;BUCCAL, SUBLINGUALStrengthEQ 0.1MG BASE
Approval Date:Sep 25, 2006TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 26, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
Patent:  Start TrialPatent Expiration:Mar 26, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
Patent:  Start TrialPatent Expiration:Jun 15, 2028Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021947

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-003 Sep 25, 2006   Start Trial   Start Trial
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-002 Sep 25, 2006   Start Trial   Start Trial
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-001 Sep 25, 2006   Start Trial   Start Trial
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-004 Sep 25, 2006   Start Trial   Start Trial
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-003 Sep 25, 2006   Start Trial   Start Trial
Cephalon FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947-004 Sep 25, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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