ADVAIR HFA Drug Patent Profile
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Which patents cover Advair Hfa, and when can generic versions of Advair Hfa launch?
Advair Hfa is a drug marketed by Glaxo Grp Ltd and is included in one NDA. There is one patent protecting this drug.
This drug has twenty-nine patent family members in seventeen countries.
The generic ingredient in ADVAIR HFA is fluticasone propionate; salmeterol xinafoate. There are twenty-nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Advair Hfa
A generic version of ADVAIR HFA was approved as fluticasone propionate; salmeterol xinafoate by HIKMA on December 17th, 2020.
Summary for ADVAIR HFA
International Patents: | 29 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 7 |
Clinical Trials: | 83 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ADVAIR HFA |
Drug Sales Revenues: | Drug sales revenues for ADVAIR HFA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ADVAIR HFA |
What excipients (inactive ingredients) are in ADVAIR HFA? | ADVAIR HFA excipients list |
DailyMed Link: | ADVAIR HFA at DailyMed |
Recent Clinical Trials for ADVAIR HFA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Becro Ltd. | Phase 3 |
Teva Pharmaceuticals USA | Phase 3 |
Respirent Pharmaceuticals Co Ltd. | Phase 1 |
Pharmacology for ADVAIR HFA
Drug Class | Corticosteroid beta2-Adrenergic Agonist |
Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for ADVAIR HFA
US Patents and Regulatory Information for ADVAIR HFA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxo Grp Ltd | ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254-001 | Jun 8, 2006 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Glaxo Grp Ltd | ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254-002 | Jun 8, 2006 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Glaxo Grp Ltd | ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254-003 | Jun 8, 2006 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 |
Expired US Patents for ADVAIR HFA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxo Grp Ltd | ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254-003 | Jun 8, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxo Grp Ltd | ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254-001 | Jun 8, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxo Grp Ltd | ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254-001 | Jun 8, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxo Grp Ltd | ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254-003 | Jun 8, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ADVAIR HFA
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Teva B.V. | Airexar Spiromax | salmeterol xinafoate, fluticasone propionate | EMEA/H/C/004267 Airexar Spiromax is indicated for use in adults aged 18 years and older only.AsthmaAirexar Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:- patients not adequately controlled on a lower strength corticosteroid combination productor- patients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist.Chronic Obstructive Pulmonary Disease (COPD)Airexar Spiromax is indicated for the symptomatic treatment of patients with COPD, with a FEV1 |
Withdrawn | no | no | no | 2016-08-18 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ADVAIR HFA
See the table below for patents covering ADVAIR HFA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2293487 | DISTRIBUTEUR A COMPTEUR DE DOSES (DISPENSER WITH DOSES COUNTER) | ⤷ Try a Trial |
Spain | 2175515 | ⤷ Try a Trial | |
Estonia | 9700285 | ⤷ Try a Trial | |
China | 1241979 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ADVAIR HFA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1519731 | 13C0067 | France | ⤷ Try a Trial | PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215 |
1305329 | 08C0014 | France | ⤷ Try a Trial | PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111 |
0416951 | 12/1999 | Austria | ⤷ Try a Trial | PRODUCT NAME: SALMETEROL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH DES 1-HYDROXY-2-NAPHTHOATS (XINAFOAT) UND FLUTICASON PROPIONAT; NAT. REGISTRATION NO/DATE: 1-22897,1-22898, 1-22899,1-22900, 1-22901,1-22902 19990204; FIRST REGISTRATION: SE 14591-14596 19980907 |
1519731 | 92269 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |