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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Healthtrust
Merck
US Army
Moodys
Argus Health
UBS
Federal Trade Commission
Baxter
McKinsey

Generated: January 22, 2018

DrugPatentWatch Database Preview

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 one supplier. 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. Sixteen 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
Therapeutic Class:Analgesics
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 Cephalon, Inc. 63459-541 63459-541-28 28 BLISTER PACK in 1 CARTON (63459-541-28) > 1 TABLET in 1 BLISTER PACK (63459-541-04)
FENTORA fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 021947 NDA Cephalon, Inc. 63459-542 63459-542-28 28 BLISTER PACK in 1 CARTON (63459-542-28) > 1 TABLET in 1 BLISTER PACK (63459-542-04)

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

UBS
US Army
Cantor Fitzgerald
Express Scripts
Harvard Business School
Teva
Medtronic
Mallinckrodt
AstraZeneca

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 verifification 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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