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AIRDUO RESPICLICK Drug Profile
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When do Airduo Respiclick patents expire, and what generic alternatives are available?
Airduo Respiclick is a drug marketed by Teva Pharm and is included in one NDA. There are nineteen patents protecting this drug.
This drug has three hundred and ninety-seven patent family members in thirty-six countries.
The generic ingredient in AIRDUO RESPICLICK is fluticasone propionate; salmeterol xinafoate. There are twenty-nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.
US ANDA Litigation and Generic Entry Outlook for Airduo Respiclick
Airduo Respiclick was eligible for patent challenges on December 31st, 1968.
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Historic data indicate that 48% of cases that proceed to trial are decided in favor of the generic patent challenger.
Summary for AIRDUO RESPICLICK
| International Patents: | 397 |
| US Patents: | 19 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 1 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AIRDUO RESPICLICK |
| DailyMed Link: | AIRDUO RESPICLICK at DailyMed |
Recent Litigation for AIRDUO RESPICLICK
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Teva Branded Pharmaceutical Products R&D Inc. v. Perrigo Pharmaceuticals Co. | 2013-08-16 |
Pharmacology for AIRDUO RESPICLICK
| Drug Class | Corticosteroid beta2-Adrenergic Agonist |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists Adrenergic beta2-Agonists |
Synonyms for AIRDUO RESPICLICK
| Adoair |
| Advair |
| Advair HFA Inhalation Aerosol |
| Fluticasone / Salmeterol |
| Fluticasone propionate and salmeterol xinafoate |
| Fluticasone propionate mixt. with Salmeterol |
| Fluticasone-Salmeterol Drug Combination |
| fluticasone, salmeterol drug combination |
| Seretide |
| Seretide Accuhaler |
| Seretide Diskus |
| Seroflo |
US Patents and Regulatory Information for AIRDUO RESPICLICK
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Pharm | AIRDUO RESPICLICK | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-003 | Jan 27, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Teva Pharm | AIRDUO RESPICLICK | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-002 | Jan 27, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Teva Pharm | AIRDUO RESPICLICK | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-003 | Jan 27, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 AIRDUO RESPICLICK
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Teva Pharm | AIRDUO RESPICLICK | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-002 | Jan 27, 2017 | Start Trial | Start Trial |
| Teva Pharm | AIRDUO RESPICLICK | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-001 | Jan 27, 2017 | Start Trial | Start Trial |
| Teva Pharm | AIRDUO RESPICLICK | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-003 | Jan 27, 2017 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AIRDUO RESPICLICK
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Taiwan | 201628607 | Start Trial |
| Poland | 2514462 | Start Trial |
| New Zealand | 618744 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for AIRDUO RESPICLICK
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1519731 | 92269 | Luxembourg | Start Trial | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE |
| 1519731 | 13C0067 | France | Start 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 |
| 2506844 | 1890025-8 | Sweden | Start Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
