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Serving leading biopharmaceutical companies globally:

Harvard Business School
Chinese Patent Office
Queensland Health
US Department of Justice
Cantor Fitzgerald
Johnson and Johnson

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207071

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NDA 207071 describes FINACEA , which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from four suppliers. There are seven patents protecting this drug. Additional details are available on the FINACEA profile page.

The generic ingredient in FINACEA is azelaic acid. There are eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the azelaic acid profile page.
Summary for 207071
Applicant:Bayer Hlthcare
Ingredient:azelaic acid
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 207071
Suppliers and Packaging for NDA: 207071
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-829 50419-829-72 1 CAN in 1 CARTON (50419-829-72) > 15 g in 1 CAN
FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-829 50419-829-71 1 CAN in 1 CARTON (50419-829-71) > 30 g in 1 CAN

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, FOAM;TOPICALStrength15%
Approval Date:Jul 29, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 29, 2018
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ SubscribePatent Expiration:Sep 8, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:➤ SubscribePatent Expiration:Sep 18, 2027Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Boehringer Ingelheim
Johnson and Johnson
Chinese Patent Office

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.