FLUTICASONE FUROATE; VILANTEROL TRIFENATATE - Generic Drug Details
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What are the generic drug sources for fluticasone furoate; vilanterol trifenatate and what is the scope of patent protection?
Fluticasone furoate; vilanterol trifenatate
is the generic ingredient in one branded drug marketed by Glaxo Grp Ltd and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Fluticasone furoate; vilanterol trifenatate has two hundred and twelve patent family members in thirty-two countries.
Two suppliers are listed for this compound.
Summary for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
| International Patents: | 212 |
| US Patents: | 7 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Clinical Trials: | 4 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE |
| DailyMed Link: | FLUTICASONE FUROATE; VILANTEROL TRIFENATATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
Generic Entry Date for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;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 FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| SRL Mediserch.Inc | Phase 3 |
| Parexel International Japan | Phase 3 |
| Q2 Solutions, LLC | Phase 3 |
See all FLUTICASONE FUROATE; VILANTEROL TRIFENATATE clinical trials
Pharmacology for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
| Drug Class | Corticosteroid beta2-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
US Patents and Regulatory Information for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
| 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 | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-002 | Apr 30, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-001 | May 10, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-002 | Apr 30, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-003 | May 12, 2023 | RX | Yes | No | ⤷ 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 FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-001 | May 10, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-001 | May 10, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-002 | Apr 30, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-001 | May 10, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Mexico | PA05001026 | DISTRIBUIDOR DE MEDICAMENTOS. (MEDICAMENT DISPENSER.) | ⤷ Try a Trial |
| Malaysia | 129422 | MEDICINAL COMPOUNDS | ⤷ Try a Trial |
| United Kingdom | 0126997 | ⤷ Try a Trial | |
| Mexico | PA04002405 | DERIVADOS DE FENETANOLAMINA PARA TRATAMIENTO DE ENFERMEDADES RESPIRATORIAS. (PHENETHANOLAMINE DERIVATIVES FOR TREATMENT OF RESPIRATORY DISEASES.) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1425001 | 122014000051 | Germany | ⤷ Try a Trial | PRODUCT NAME: VILANTEROL ODER EIN SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113 |
| 1425001 | 174 50004-2014 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: VILANTEROLTRIFENATAT; REGISTRATION NO/DATE: EU/1/13/886/001 - EU/1/13/886/006 20131113 |
| 1519731 | 132013902182575 | Italy | ⤷ Try a Trial | 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 | 18C1022 | France | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (EN PARTICULIER LE BROMURE D'UMECLIDINIUM), DU VILANTEROL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (EN PARTICULIER LE TRIFENATATE DE VILANTEROL), ET DU FUROATE DE FLUTICASONE; REGISTRATION NO/DATE: EU/1/17/1236 20171117 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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