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Serving leading biopharmaceutical companies globally:

Medtronic
Mallinckrodt
Colorcon
Queensland Health
Citi
US Army
Chubb
McKinsey
US Department of Justice
Fuji

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205613

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NDA 205613 describes UCERIS, which is a drug marketed by Valeant Pharms Intl and is included in two NDAs. It is available from two suppliers. There are ten patents protecting this drug and one Paragraph IV challenge. Additional details are available on the UCERIS profile page.

The generic ingredient in UCERIS is budesonide. There are twenty-one drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the budesonide profile page.
Summary for 205613
Pharmacology for NDA: 205613
Medical Subject Heading (MeSH) Categories for 205613
Suppliers and Packaging for NDA: 205613
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
UCERIS budesonide AEROSOL, FOAM;RECTAL 205613 NDA Salix Pharmaceuticals, Inc. 65649-651 65649-651-03 2 CANISTER in 1 CARTON (65649-651-03) > 1 AEROSOL, FOAM in 1 CANISTER (65649-651-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, FOAM;RECTALStrength2MG/ACTUATION
Approval Date:Oct 7, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 7, 2017
Regulatory Exclusivity Use:NEW PRODUCT

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Julphar
Merck
Argus Health
Chinese Patent Office
Moodys
Mallinckrodt
Johnson and Johnson
Citi

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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