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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Boehringer Ingelheim
US Army
Harvard Business School
US Department of Justice

Generated: August 18, 2017

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 drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the budesonide profile page.

Summary for NDA: 205613

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 205613

Suppliers and Packaging for NDA: 205613

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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)

Summary 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

Expired Orange Book Patents for NDA: 205613

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms Intl
AEROSOL, FOAM;RECTAL205613-001Oct 7, 2014► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Harvard Business School
Express Scripts
Johnson and Johnson
Cantor Fitzgerald

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