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Last Updated: November 3, 2024

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SYMBICORT Drug Patent Profile


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When do Symbicort patents expire, and what generic alternatives are available?

Symbicort is a drug marketed by Astrazeneca and is included in two NDAs. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty-two patent family members in thirty-nine countries.

The generic ingredient in SYMBICORT is budesonide; formoterol fumarate. There are twenty-two drug master file entries for this compound. Additional details are available on the budesonide; formoterol fumarate profile page.

DrugPatentWatch® Generic Entry Outlook for Symbicort

Annual sales in 2021 were $4.6bn, indicating a strong incentive for generic entry (peak sales were $5.7bn in 2019).

There have been eleven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for SYMBICORT
Drug Prices for SYMBICORT

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Drug Sales Revenue Trends for SYMBICORT

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Recent Clinical Trials for SYMBICORT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Morten Hostrup, PhDN/A
University of AlbertaPhase 1
Cipla Ltd.Phase 3

See all SYMBICORT clinical trials

Paragraph IV (Patent) Challenges for SYMBICORT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SYMBICORT Metered Inhalation budesonide; formoterol fumarate dihydrate 80 mcg/4.5 mcg per inhalation and 160 mcg/4.5 mcg per inhalation 021929 1 2018-06-26

US Patents and Regulatory Information for SYMBICORT

SYMBICORT is protected by five US patents.

Patents protecting SYMBICORT

Inhaler device counter
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Inhaler cap strap
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Inhaler device that reduces the risk for miscounting a dosage
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Inhalation device and a method for assembling said inhalation device
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Inhaler cap strap
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for SYMBICORT

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

EU/EMA Drug Approvals for SYMBICORT

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Teva Pharma B.V.  Budesonide/Formoterol Teva Pharma B.V. budesonide, formoterol fumarate dihydrate EMEA/H/C/004882
Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only.AsthmaBudesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:-in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.or-in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.COPDSymptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV1) 
Authorised no no no 2020-04-03
Teva Pharma B.V. Budesonide/Formoterol Teva Pharma B.V. budesonide, formoterol fumarate dihydrate EMEA/H/C/003953
Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only.AsthmaBudesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: orin patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists. 
Withdrawn no no no 2014-11-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for SYMBICORT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0613371 SPC016/2002 Ireland ⤷  Sign Up SPC016/2002: 20041105, EXPIRES: 20150824
0613371 SPC/GB02/033 United Kingdom ⤷  Sign Up PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
0613371 2002C/022 Belgium ⤷  Sign Up PRODUCT NAME: BUDESONID. MICRONIS. AND FORMOTEROL. FUMARAS DIHYDR., NATL REGISTRATION NO/DATE: 624 IS 234 F 0 20010129; FIRST REGISTRATION: SE 16047 20000825
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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