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 |
---|---|
Bond Avillion 2 Development LP | Phase 3 |
Parexel | 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 | ⤷ Free Trial | ⤷ Free Trial | ⤷ Free Trial | ||||
Astrazeneca | AIRSUPRA | albuterol sulfate; budesonide | AEROSOL, METERED;INHALATION | 214070-001 | Jan 10, 2023 | RX | Yes | Yes | 9,415,009 | ⤷ Free Trial | ⤷ Free Trial | ||||
>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 |
---|---|---|---|
Hungary | E047823 | ⤷ Free Trial | |
Taiwan | 201109051 | Compositions, methods and systems for respiratory delivery of two or more active agents | ⤷ Free Trial |
Poland | 2435024 | ⤷ Free Trial | |
Japan | 6492124 | ⤷ Free Trial | |
Portugal | 3111926 | ⤷ Free Trial | |
Japan | 2015187108 | 活性剤を呼吸器送達するための組成物、ならびに関連する方法および系 (COMPOSITIONS FOR RESPIRATORY DELIVERY OF ACTIVE AGENTS AND ASSOCIATED METHODS AND SYSTEMS) | ⤷ Free Trial |
>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 | 122021000026 | Germany | ⤷ Free Trial | PRODUCT NAME: GLYCOPYRROLAT MIT FORMOTEROL MIT BUDESONID, ODER SALZE, ESTER, SOLVATE, ENANTIOMERE UND MISCHUNGEN VON ENANTIOMEREN DERSELBEN; REGISTRATION NO/DATE: EU/1/20/1498 20201209 |
2435025 | C201930043 | Spain | ⤷ Free Trial | PRODUCT NAME: UNA COMBINACION DE GLICOPIRROLATO (INCLUYENDO CUALQUIERA DE SUS SALES, ESTERES O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES) Y FORMOTEROL (INCLUYENDO CUALQUIERA DE SUS SALES, ESTERES O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES).; NATIONAL AUTHORISATION NUMBER: EU/1/18/1339; DATE OF AUTHORISATION: 20181218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1339; DATE OF FIRST AUTHORISATION IN EEA: 20181218 |
2435024 | 2021019 | Norway | ⤷ Free Trial | PRODUCT NAME: KOMBINASJON AV FORMOTEROL; REG. NO/DATE: EU/1/20/1498 20201216 |
2435025 | 2019C/532 | Belgium | ⤷ Free Trial | PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI) ET DE FORMOTEROL (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220 |
2435024 | 301102 | Netherlands | ⤷ Free Trial | 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 |
2435024 | SPC/GB21/029 | United Kingdom | ⤷ Free Trial | PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Albuterol Sulfate and Budesonide
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