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Profile for Tradename: SYMBICORT

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Symbicort is a drug marketed by Astrazeneca and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug.

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

The generic ingredient in SYMBICORT is budesonide; formoterol fumarate dihydrate. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the budesonide; formoterol fumarate dihydrate profile page.

Summary for Tradename: SYMBICORT

Patents:14
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
Formulation / Manufacturing:see details
2013 Sales:$1,563,242,000

Clinical Trials for: SYMBICORT

A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma
Status: Completed Condition: Asthma

Study to Investigate Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy in Asthma Patients Across Asia
Status: Completed Condition: Asthma

Comparing Bronchodilation of Symbicort With and With Out Valved Holding Chamber (Aerochamber Plus)
Status: Recruiting Condition: Asthma

Symbicort Rapihaler Therapeutic Equivalence Study
Status: Completed Condition: Bronchial Asthma

Long-Term Safety of Symbicort in Asthmatic Children - SAPLING
Status: Completed Condition: Asthma

Atlantis Symbicort
Status: Completed Condition: Asthma

Onset of Action of Advair Hydrofluoroalkane (HFA) 115/21 in Comparison to Symbicort Pressurised Metered-Dose Inhalers (pMDI) 160/4.5 Measured by Impulse Oscillometry (IOS)
Status: Recruiting Condition: Asthma

Gemini Symbicort pMDI
Status: Completed Condition: Mild or Moderate Asthma

Study to Compare the Effects of Z7200 And Symbicort® Turbohaler on Respiratory Imaging Parameters in Asthmatic Patients
Status: Completed Condition: Asthma; Asthma Chronic; Asthma Bronchial; Asthmatic

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

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;INHALATION021929-001Jul 21, 2006RXYes5,674,860<disabled>Y<disabled>
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, 2006RXYes7,367,333<disabled>Y<disabled>
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-001Jul 21, 2006RXYes8,616,196<disabled>Y<disabled>
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-001Jul 21, 2006RXYes8,575,137<disabled>Y<disabled>
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Non-Orange Book Patents for Tradename: SYMBICORT

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
8,584,668Inhalation 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>
7,743,765Inhalation device<disabled in preview>
6,641,800 Pressurized aerosol compositions comprising powdered medicament dispersed in hydrofluoroalkane<disabled in preview>
7,819,075Inhaler device counter<disabled in preview>
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International Patent Family for Tradename: SYMBICORT

Country Document Number Publication Date
Australia2647192Apr 27, 1993
Netherlands300094Feb 03, 2003
China102058921May 18, 2011
New Zealand552104Dec 24, 2009
Hungary210818Aug 28, 1995
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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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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