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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Questions you can ask:
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Summary for SYMBICORT
International Patents: | 162 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 3 |
Clinical Trials: | 145 |
Drug Prices: | Drug price information for SYMBICORT |
Drug Sales Revenues: | Drug sales revenues for SYMBICORT |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SYMBICORT |
What excipients (inactive ingredients) are in SYMBICORT? | SYMBICORT excipients list |
DailyMed Link: | SYMBICORT at DailyMed |
Recent Clinical Trials for SYMBICORT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Morten Hostrup, PhD | N/A |
University of Alberta | Phase 1 |
Cipla Ltd. | Phase 3 |
Pharmacology for SYMBICORT
Drug Class | Corticosteroid beta2-Adrenergic Agonist |
Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
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 |
International Patents for SYMBICORT
See the table below for patents covering SYMBICORT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 101127721 | ⤷ Sign Up | |
Malaysia | 135868 | INHALER CAP STRAP | ⤷ Sign Up |
Taiwan | 200526283 | Inhaler cap strap | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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 |