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Details for Generic Name: budesonide; formoterol fumarate dihydrate

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Budesonide; formoterol fumarate dihydrate is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has three hundred and forty-eight patent family members in fifty countries.

There are nineteen drug master file entries for budesonide; formoterol fumarate dihydrate. One supplier is listed for this compound.

Summary for Generic Name: budesonide; formoterol fumarate dihydrate

Tradenames:1
Patents:14
Applicants:1
NDAs:1
Drug Master File Entries: see list19
Suppliers: see list1
Formulation / Manufacturing:see details

Pharmacology for Ingredient: budesonide; formoterol fumarate dihydrate

Clinical Trials for: budesonide; formoterol fumarate dihydrate

Efficacy and Safety Study of PT009, PT008, and PT005 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Status: Completed Condition: Chronic Obstructive Pulmonary Disease (COPD)

Effects of Symbicort on the Ventilatory Kinematics
Status: Terminated Condition: Chronic Obstructive Lung Disease

Studying Genes in Blood and Lung Fluid Samples From Patients With Chronic Obstructive Pulmonary Disease With or Without a Previous Diagnosis of Lung Cancer or With Asthma Treated With Budesonide and Formoterol
Status: Completed Condition: Lung Cancer; Precancerous Condition

Bioequivalence Study of Budesonide/Formoterol Easyhaler and Symbicort Turbohaler in Asthmatics
Status: Completed Condition: Asthma

Comparison of Absorption of Budesonide and Formoterol From Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler
Status: Completed Condition: Asthma

Comparison of Budesonide and Formoterol Absorption From Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler
Status: Completed Condition: Asthma

Phase I Study Evaluating the Safety and Pharmacokinetics of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI) in Healthy Volunteers
Status: Completed Condition: Healthy Volunteers

Pharmacokinetics and Safety Study of PT010 in Healthy Subjects
Status: Completed Condition: COPD

Study to Evaluate the Mastery of Inhaler Technique for Budesonide Formoterol (BF) SPIROMAX® as Compared to SYMBICORT® TURBOHALER® as Treatment for Adult Patients With Asthma
Status: Completed Condition: Asthma

A Non-inferiority Study to Evaluate Efficacy, Safety and Tolerability of NEUMOTEROL® 400 and SYMBICORT® Forte in Adults With Asthma
Status: Recruiting Condition: Asthma

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 2006RXYes8,575,137<disabled>Y<disabled>
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 2006RXYes8,875,699<disabled>Y<disabled>
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-001Jul 21, 2006RXYes8,575,137<disabled>Y<disabled>
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 2006RXYes8,616,196<disabled>Y<disabled>
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 2006RXYes8,461,211<disabled><disabled>
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Non-Orange Book Patents for Generic Ingredient: budesonide; formoterol fumarate dihydrate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
2,006,189,587<disabled in preview>
7,743,765Inhalation device<disabled in preview>
5,972,919 Combination of a bronchodilator and a steroidal anti-inflammatory drug for the treatment of respiratory disorders, as well as its use and the preparation thereof<disabled in preview>
7,819,075Inhaler device counter<disabled in preview>
6,641,800 Pressurized aerosol compositions comprising powdered medicament dispersed in hydrofluoroalkane<disabled in preview>
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International Patent Family for Ingredient: budesonide; formoterol fumarate dihydrate

Country Document Number Publication Date
Taiwan216442Nov 21, 1993
Norway20062607Jun 06, 2006
Japan2010132695Jun 17, 2010
Canada2616784Jul 19, 2011
New Zealand246050Dec 21, 1995
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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