Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Medtronic
Mallinckrodt
Baxter
Express Scripts
Moodys
Colorcon

Last Updated: October 16, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021929

See Plans and Pricing

« Back to Dashboard

NDA 021929 describes SYMBICORT, which is a drug marketed by Astrazeneca and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SYMBICORT profile page.

The generic ingredient in SYMBICORT is budesonide; formoterol fumarate dihydrate. There are twenty-two 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 021929
Tradename:SYMBICORT
Applicant:Astrazeneca
Ingredient:budesonide; formoterol fumarate dihydrate
Patents:13
Generic Entry Opportunity Date for 021929
Generic Entry Date for 021929*:
Constraining patent/regulatory exclusivity:
Dosage:
AEROSOL, METERED;INHALATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 021929
Suppliers and Packaging for NDA: 021929
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929 NDA AstraZeneca Pharmaceuticals LP 0186-0370 0186-0370-20 1 POUCH in 1 CARTON (0186-0370-20) > 1 CANISTER in 1 POUCH > 120 AEROSOL in 1 CANISTER
SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929 NDA AstraZeneca Pharmaceuticals LP 0186-0370 0186-0370-28 1 POUCH in 1 CARTON (0186-0370-28) > 1 CANISTER in 1 POUCH > 60 AEROSOL in 1 CANISTER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.08MG/INH;0.0045MG/INH
Approval Date:Jul 21, 2006TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 11, 2020
Regulatory Exclusivity Use:INFORMATION ADDED TO LABELING TO SUPPORT THE USE OF SYMBICORT TO REDUCE EXACERBATIONS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Regulatory Exclusivity Expiration:Dec 20, 2020
Regulatory Exclusivity Use:INFORMATION ADDED TO THE CLINICAL TRIALS SECTION OF THE LABELING REGARDING A POSTMARKETING SAFETY AND EFFICACY STUDY EVALUATING THE RISK OF SERIOUS ASTHMA-RELATED EVENTS
Regulatory Exclusivity Expiration:Jan 27, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Expired US Patents for NDA 021929

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006   Request a Trial   Request a Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006   Request a Trial   Request a Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006   Request a Trial   Request a Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006   Request a Trial   Request a Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006   Request a Trial   Request a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Baxter
Express Scripts
Moodys
Dow
McKinsey

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.