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Fluticasone propionate; salmeterol xinafoate - Generic Drug Details
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What are the generic sources for fluticasone propionate; salmeterol xinafoate and what is the scope of freedom to operate?
Fluticasone propionate; salmeterol xinafoate
is the generic ingredient in seven branded drugs marketed by Glaxo Grp Ltd, Teva Pharm, and Mylan, and is included in four NDAs. There are twenty-five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Fluticasone propionate; salmeterol xinafoate has five hundred and fifty-five patent family members in forty-four countries.
There are twenty-nine drug master file entries for fluticasone propionate; salmeterol xinafoate. Eight suppliers are listed for this compound.
Summary for fluticasone propionate; salmeterol xinafoate
| International Patents: | 555 |
| US Patents: | 25 |
| Tradenames: | 7 |
| Applicants: | 3 |
| NDAs: | 4 |
| Drug Master File Entries: | 29 |
| Suppliers / Packagers: | 8 |
| Clinical Trials: | 31 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for fluticasone propionate; salmeterol xinafoate |
| DailyMed Link: | fluticasone propionate; salmeterol xinafoate at DailyMed |
Recent Clinical Trials for fluticasone propionate; salmeterol xinafoate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| BECRO Ltd. | Phase 1 |
| Respirent Pharmaceuticals Co Ltd. | Phase 1 |
| Shanghai Biomabs Pharmaceutical Co., Ltd. | Phase 3 |
See all fluticasone propionate; salmeterol xinafoate clinical trials
Recent Litigation for fluticasone propionate; salmeterol xinafoate
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Glaxo Group Ltd. v. Teva Pharmaceuticals USA, Inc. | 2017-03-31 |
| ART+COM Innovationpool GmbH v. Google Inc. | 2016-10-05 |
| Meda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. | 2015-09-08 |
See all fluticasone propionate; salmeterol xinafoate litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| Mylan Pharmaceuticals Inc. | 2015-09-29 |
See all fluticasone propionate; salmeterol xinafoate litigation
Pharmacology for fluticasone propionate; salmeterol xinafoate
| Drug Class | Corticosteroid beta2-Adrenergic Agonist |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists Adrenergic beta2-Agonists |
US Patents and Regulatory Information for fluticasone propionate; salmeterol xinafoate
| 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 | 208799-001 | Jan 27, 2017 | RX | Yes | No | 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 | 208799-002 | Jan 27, 2017 | RX | Yes | No | 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 fluticasone propionate; salmeterol xinafoate
| 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 | Start Trial | Start Trial |
| Glaxo Grp Ltd | ADVAIR HFA | fluticasone propionate; salmeterol xinafoate | AEROSOL, METERED;INHALATION | 021254-003 | Jun 8, 2006 | Start Trial | Start Trial |
| Glaxo Grp Ltd | ADVAIR DISKUS 500/50 | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 021077-003 | Aug 24, 2000 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for fluticasone propionate; salmeterol xinafoate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 1294421 | Start Trial |
| Portugal | 1516283 | Start Trial |
| Spain | 2529358 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for fluticasone propionate; salmeterol xinafoate
| 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 |
| 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 |
| 1305329 | SPC/GB08/026 | United Kingdom | Start Trial | PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080111; UK EU/1/07/434/002 20080111; UK EU/1/07/434/003 20080111 |
| >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 verifification 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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