ADVAIR DISKUS 500/50 Drug Patent Profile
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When do Advair Diskus 500/50 patents expire, and what generic alternatives are available?
Advair Diskus 500/50 is a drug marketed by Glaxo Grp Ltd and is included in one NDA.
The generic ingredient in ADVAIR DISKUS 500/50 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 Diskus 500/50
A generic version of ADVAIR DISKUS 500/50 was approved as fluticasone propionate; salmeterol xinafoate by HIKMA on December 17th, 2020.
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Summary for ADVAIR DISKUS 500/50
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 7 |
| Clinical Trials: | 59 |
| DailyMed Link: | ADVAIR DISKUS 500/50 at DailyMed |
Recent Clinical Trials for ADVAIR DISKUS 500/50
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Becro Ltd. | Phase 3 |
| Teva Pharmaceuticals USA | Phase 3 |
| Becro Ltd. | Phase 1 |
Pharmacology for ADVAIR DISKUS 500/50
| Drug Class | Corticosteroid beta2-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
US Patents and Regulatory Information for ADVAIR DISKUS 500/50
| 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 DISKUS 500/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-003 | Aug 24, 2000 | AB | 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 |
Expired US Patents for ADVAIR DISKUS 500/50
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxo Grp Ltd | ADVAIR DISKUS 500/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-003 | Aug 24, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxo Grp Ltd | ADVAIR DISKUS 500/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-003 | Aug 24, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxo Grp Ltd | ADVAIR DISKUS 500/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-003 | Aug 24, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxo Grp Ltd | ADVAIR DISKUS 500/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-003 | Aug 24, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ADVAIR DISKUS 500/50
| 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 DISKUS 500/50
See the table below for patents covering ADVAIR DISKUS 500/50 around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hong Kong | 36889 | PHENETHANOLAMINE DERIVATIVES | ⤷ Sign Up |
| Norway | 159016 | ⤷ Sign Up | |
| Ireland | 910698 | ⤷ Sign Up | |
| Singapore | 169094 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ADVAIR DISKUS 500/50
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1519731 | 132013902182575 | Italy | ⤷ Sign Up | PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527 |
| 2506844 | 1890025-8 | Sweden | ⤷ Sign Up | PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117 |
| 1519731 | 13C0067 | France | ⤷ Sign Up | 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 |
| 2506844 | 2018C/022 | Belgium | ⤷ Sign Up | PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT DAT EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BV. UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BV. VILANTEROLTRIFENATAAT) EN FLUTICASONEFUROAAT OMVAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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