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Fluticasone propionate - Generic Drug Details

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Fluticasone propionate is the generic ingredient in fifteen branded drugs marketed by Fougera Pharms, West-ward Pharms Int, Glaxosmithkline, Glaxo Grp Ltd, Tolmar, Glaxosmithkline Cons, Apotex Inc, Taro Pharm Inds, Perrigo Israel, G And W Labs, Glenmark Generics, Nesher Pharms, Perrigo New York, Hi Tech Pharma, Wockhardt, and Teva Pharm, and is included in thirty NDAs. There are thirty-one patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has four hundred and twenty-one patent family members in fifty-six countries.

There are twenty-two drug master file entries for fluticasone propionate. Sixty-nine suppliers are listed for this compound.

Summary for Generic Name: fluticasone propionate

Tradenames:15
Patents:31
Applicants:16
NDAs:30
Drug Master File Entries: see list22
Suppliers / Packagers: see list69
Bulk Api Vendors: see list44
Clinical Trials: see list194
Patent Applications: see list6,513
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Respiratory Tract Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:fluticasone propionate at DailyMed

Pharmacology for Ingredient: fluticasone propionate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharm
AIRDUO RESPICLICK
fluticasone propionate; salmeterol xinafoate
POWDER;INHALATION208799-003Jan 27, 2017RXYesYes9,463,288► subscribeY ► subscribe
Fougera Pharms
CUTIVATE
fluticasone propionate
CREAM;TOPICAL019958-001Dec 18, 1990DISCNYesNo► subscribe► subscribe
Teva Pharm
ARMONAIR RESPICLICK
fluticasone propionate
POWDER;INHALATION208798-002Jan 27, 2017RXYesNo8,651,103► subscribeY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: fluticasone propionate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd
FLOVENT DISKUS 100
fluticasone propionate
POWDER;INHALATION020833-002Sep 29, 20006,032,666*PED► subscribe
Glaxo Grp Ltd
FLOVENT DISKUS 250
fluticasone propionate
POWDER;INHALATION020833-003Sep 29, 20007,225,808*PED► subscribe
Glaxo Grp Ltd
FLOVENT HFA
fluticasone propionate
AEROSOL, METERED;INHALATION021433-002May 14, 20046,546,928*PED► subscribe
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Non-Orange Book Patents for Generic Ingredient: fluticasone propionate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,174,013Dose counters for inhalers, inhalers and methods of assembly thereof► subscribe
7,389,775Inhalation device► subscribe
7,101,534Suspension aerosol formulations► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: fluticasone propionate

Country Document Number Estimated Expiration
Uruguay26795► subscribe
Mexico2012005238► subscribe
World Intellectual Property Organization (WIPO)0200280► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: FLUTICASONE PROPIONATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
269Luxembourg► subscribePRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
C0067France► subscribePRODUCT 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
C/GB08/026United Kingdom► subscribePRODUCT 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
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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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