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Last Updated: March 19, 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

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

See drug prices for SYMBICORT

Drug Sales Revenue Trends for SYMBICORT

See drug sales revenues for SYMBICORT

Recent Clinical Trials for SYMBICORT

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

SponsorPhase
Cipla Ltd.Phase 3
Assistance Publique - Hôpitaux de ParisPhase 3
Istituto di Biomedicina e Immunologia Molecolare Alberto MonroyPhase 4

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Inhaler cap strap
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Inhaler device that reduces the risk for miscounting a dosage
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Inhalation device and a method for assembling said inhalation device
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Inhaler cap strap
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca SYMBICORT AEROSPHERE budesonide; formoterol fumarate AEROSOL, METERED;INHALATION 216579-001 Apr 28, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 ⤷  Try a Trial ⤷  Try a Trial
>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

International Patents for SYMBICORT

See the table below for patents covering SYMBICORT around the world.

Country Patent Number Title Estimated Expiration
Malaysia 143551 INHALER DEVICE COUNTER ⤷  Try a Trial
China 100563743 ⤷  Try a Trial
Portugal 1768728 ⤷  Try a Trial
Austria 132739 ⤷  Try a Trial
China 1191871 ⤷  Try a Trial
Russian Federation 2006120952 ПОЛОСКА ДЛЯ КОЛПАЧКА ИНГАЛЯТОРА ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SYMBICORT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0613371 SPC/GB02/033 United Kingdom ⤷  Try a Trial 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 CA 2002 00019 Denmark ⤷  Try a Trial
0613371 2002C/022 Belgium ⤷  Try a Trial PRODUCT NAME: BUDESONID. MICRONIS. AND FORMOTEROL. FUMARAS DIHYDR., NATL REGISTRATION NO/DATE: 624 IS 234 F 0 20010129; FIRST REGISTRATION: SE 16047 20000825
0613371 SPC016/2002 Ireland ⤷  Try a Trial SPC016/2002: 20041105, EXPIRES: 20150824
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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