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Last Updated: August 14, 2022

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 one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

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

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

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
Cipla Ltd.Phase 3
Assistance Publique - Hôpitaux de ParisPhase 3
Istituto per la Ricerca e l'Innovazione BiomedicaPhase 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 eleven US patents.

Patents protecting SYMBICORT

Composition for inhalation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Composition for inhalation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Inhaler device counter
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Composition for inhalation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Inhalation device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Composition for inhalation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Inhaler cap strap
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Inhaler device that reduces the risk for miscounting a dosage
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Composition for inhalation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Inhalation device and a method for assembling said inhalation device
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Inhaler cap strap
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-002 Jul 21, 2006 See Plans and Pricing See Plans and Pricing
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 See Plans and Pricing See Plans and Pricing
>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 SPC/GB02/033 United Kingdom See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: BUDESONID. MICRONIS. AND FORMOTEROL. FUMARAS DIHYDR., NATL REGISTRATION NO/DATE: 624 IS 234 F 0 20010129; FIRST REGISTRATION: SE 16047 20000825
0613371 CA 2002 00019 Denmark See Plans and Pricing
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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McKesson
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