Albuterol sulfate; budesonide - Generic Drug Details
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What are the generic sources for albuterol sulfate; budesonide and what is the scope of patent protection?
Albuterol sulfate; budesonide
is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Albuterol sulfate; budesonide has one hundred and eighty-four patent family members in thirty-one countries.
One supplier is listed for this compound.
Summary for albuterol sulfate; budesonide
International Patents: | 184 |
US Patents: | 1 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 3 |
DailyMed Link: | albuterol sulfate; budesonide at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for albuterol sulfate; budesonide
Generic Entry Date for albuterol sulfate; budesonide*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT 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.
Recent Clinical Trials for albuterol sulfate; budesonide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Parexel | Phase 3 |
Bond Avillion 2 Development LP | Phase 3 |
AstraZeneca | Phase 1 |
Pharmacology for albuterol sulfate; budesonide
Drug Class | Corticosteroid beta2-Adrenergic Agonist |
Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for albuterol sulfate; budesonide
US Patents and Regulatory Information for albuterol sulfate; budesonide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca | AIRSUPRA | albuterol sulfate; budesonide | AEROSOL, METERED;INHALATION | 214070-001 | Jan 10, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Astrazeneca | AIRSUPRA | albuterol sulfate; budesonide | AEROSOL, METERED;INHALATION | 214070-001 | Jan 10, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for albuterol sulfate; budesonide
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2017222706 | 2つ以上の活性剤を呼吸器送達するための組成物、方法および系 (COMPOSITIONS, METHODS AND SYSTEMS FOR RESPIRATORY DELIVERY OF TWO OR MORE ACTIVE AGENTS) | ⤷ Sign Up |
Russian Federation | 2580315 | КОМПОЗИЦИИ ДЛЯ РЕСПИРАТОРНОЙ ДОСТАВКИ АКТИВНЫХ ВЕЩЕСТВ И СВЯЗАННЫЕ С НИМИ СПОСОБЫ И СИСТЕМЫ (COMPOSITIONS FOR RESPIRATORY DELIVERY OF ACTIVE SUBSTANCES AND METHODS AND SYSTEMS CONNECTED THEREWITH) | ⤷ Sign Up |
Taiwan | 201642836 | Compositions for pulmonary delivery of long-acting muscarinic antagonists and long-acting [beta]2 adrenergic receptor agonists and associated methods and systems | ⤷ Sign Up |
South Korea | 20170070274 | 지속형 무스카린 안타고니스트 및 지속형 B₂아드레날린 수용체 아고니스트의 폐 전달용 조성물, 및 연관된 방법 및 시스템 (COMPOSITIONS FOR PULMONARY DELIVERY OF LONG-ACTING MUSCARINIC ANTAGONISTS AND LONG-ACTING B2 ADRENERGIC RECEPTOR AGONISTS AND ASSOCIATED METHODS AND SYSTEMS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for albuterol sulfate; budesonide
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2435024 | LUC00208 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210 |
2435024 | CR 2021 00014 | Denmark | ⤷ Sign Up | PRODUCT NAME: KOMBINATION AF FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, OG BUDESONID, HERUNDER...; REG. NO/DATE: EU/1/20/1498 20201210 |
2435025 | PA2019014,C2435025 | Lithuania | ⤷ Sign Up | PRODUCT NAME: GLIKOPIRONIO BROMIDAS/FORMOTEROLIS; REGISTRATION NO/DATE: EU/1/18/1339 20181218 |
2435024 | 301102 | Netherlands | ⤷ Sign Up | PRODUCT NAME: COMBINATIE VAN FORMOTEROL (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN), GLYCOPYRROLAAT (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN) EN BUDESONIDE (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN); REGISTRATION NO/DATE: EU/1/20/1498 20201210 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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