Albuterol sulfate; budesonide - Generic Drug Details
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What are the generic drug sources for albuterol sulfate; budesonide and what is the scope of freedom to operate?
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Astrazeneca | AIRSUPRA | albuterol sulfate; budesonide | AEROSOL, METERED;INHALATION | 214070-001 | Jan 10, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
International Patents for albuterol sulfate; budesonide
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Africa | 201208102 | RESPIRATORY DELIVERY OF ACTIVE AGENTS | ⤷ Try a Trial |
Hong Kong | 1218867 | 活性劑的呼吸遞送 (RESPIRATORY DELIVERY OF ACTIVE AGENTS) | ⤷ Try a Trial |
Japan | 6189356 | ⤷ Try a Trial | |
Argentina | 122477 | COMPOSICIONES PARA EL SUMINISTRO DE AGENTES ACTIVOS MEDIANTE LAS VÍAS RESPIRATORIAS, Y MÉTODOS Y SISTEMAS ASOCIADOS | ⤷ Try a Trial |
Mexico | 2011012684 | COMPOSICIONES PARA SUMINISTRO RESPIRATORIO DE AGENTES ACTIVOS Y METODOS Y SISTEMAS ASOCIADOS. (COMPOSITIONS FOR RESPIRATORY DELIVERY OF ACTIVE AGENTS AND ASSOCIATED METHODS AND SYSTEMS.) | ⤷ Try a Trial |
Denmark | 2435025 | ⤷ Try a Trial | |
Poland | 3106149 | ⤷ Try a 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 |
---|---|---|---|---|
2435025 | C201930043 | Spain | ⤷ Try a 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 |
2435025 | LUC00124 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220 |
2435025 | CR 2019 00032 | Denmark | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION AF GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER SOLVATER DERAF, OG FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERE ELLER SOLVATER DERAF; REG. NO/DATE: EU/1/18/1339 20181220 |
2435024 | SPC/GB21/029 | United Kingdom | ⤷ Try a 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 |
2435024 | 301102 | Netherlands | ⤷ Try a 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 | 2190014-7 | Sweden | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210 |
2435025 | 132019000000087 | Italy | ⤷ Try a Trial | PRODUCT NAME: UNA COMBINAZIONE DI GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, ENANTIOMERI O ALTRI DERIVATI FARMACEUTICAMENTE ACCETTABILI) E FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, ENANTIOMERI O ALTRI DERIVATI FARMACEUTICAMENTE ACCETTABILI)(BEVESPI AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1339, 20181220 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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