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Serving leading biopharmaceutical companies globally:

Farmers Insurance
McKesson
Chinese Patent Office
Federal Trade Commission
Dow
Moodys
US Army
Deloitte
Chubb
McKinsey

Generated: February 17, 2018

DrugPatentWatch Database Preview

Fluticasone propionate - Generic Drug Details

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What are the generic drug sources for fluticasone propionate and what is the scope of fluticasone propionate patent protection?

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

Fluticasone propionate has six hundred and eighty-two patent family members in fifty-six countries.

There are twenty-six drug master file entries for fluticasone propionate. Eighty-two suppliers are listed for this compound.
Summary for fluticasone propionate
Pharmacology for fluticasone propionate

US Patents and Regulatory Information for fluticasone propionate

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 HFA fluticasone propionate; salmeterol xinafoate AEROSOL, METERED;INHALATION 021254-001 Jun 8, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Glaxo Grp Ltd ADVAIR HFA fluticasone propionate; salmeterol xinafoate AEROSOL, METERED;INHALATION 021254-003 Jun 8, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Teva Pharm AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-002 Jan 27, 2017 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Teva Pharm ARMONAIR RESPICLICK fluticasone propionate POWDER;INHALATION 208798-002 Jan 27, 2017 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Glaxo Grp Ltd ADVAIR HFA fluticasone propionate; salmeterol xinafoate AEROSOL, METERED;INHALATION 021254-001 Jun 8, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Glaxo Grp Ltd ADVAIR HFA fluticasone propionate; salmeterol xinafoate AEROSOL, METERED;INHALATION 021254-001 Jun 8, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Optinose Us Inc XHANCE fluticasone propionate SPRAY, METERED;NASAL 209022-001 Sep 18, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Apotex Inc FLUTICASONE PROPIONATE fluticasone propionate SPRAY, METERED;NASAL 208150-001 Feb 29, 2016 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-001 May 14, 2004 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva Pharm AIRDUO RESPICLICK fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-001 Jan 27, 2017 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for fluticasone propionate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd FLOVENT DISKUS 50 fluticasone propionate POWDER;INHALATION 020833-001 Sep 29, 2000 ➤ Sign Up ➤ Sign Up
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-002 May 14, 2004 ➤ Sign Up ➤ Sign Up
Glaxo Grp Ltd FLOVENT DISKUS 50 fluticasone propionate POWDER;INHALATION 020833-001 Sep 29, 2000 ➤ Sign Up ➤ Sign Up
Glaxo Grp Ltd FLOVENT DISKUS 250 fluticasone propionate POWDER;INHALATION 020833-003 Sep 29, 2000 ➤ Sign Up ➤ Sign Up
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-002 May 14, 2004 ➤ Sign Up ➤ Sign Up
Glaxo Grp Ltd FLOVENT DISKUS 250 fluticasone propionate POWDER;INHALATION 020833-003 Sep 29, 2000 ➤ Sign Up ➤ Sign Up
Glaxo Grp Ltd FLOVENT DISKUS 100 fluticasone propionate POWDER;INHALATION 020833-002 Sep 29, 2000 ➤ Sign Up ➤ Sign Up
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-003 May 14, 2004 ➤ Sign Up ➤ Sign Up
Glaxo Grp Ltd FLOVENT DISKUS 250 fluticasone propionate POWDER;INHALATION 020833-003 Sep 29, 2000 ➤ Sign Up ➤ Sign Up
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-002 May 14, 2004 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
9,108,010 Dose counters for inhalers, inhalers and methods of assembly thereof ➤ Sign Up
9,808,587 Dose counter for inhaler having an anti-reverse rotation actuator ➤ Sign Up
9,737,674 Dose counters for inhalers, inhalers and methods of assembly thereof ➤ Sign Up
7,101,534 Suspension aerosol formulations ➤ Sign Up
6,655,381 Pre-metered dose magazine for breath-actuated dry powder inhaler ➤ Sign Up
8,555,877 Nasal delivery device ➤ Sign Up
8,596,278 Nasal devices ➤ Sign Up
7,740,014 Nasal devices ➤ Sign Up
8,511,303 Nasal delivery devices ➤ Sign Up
9,533,111 Dose counters for inhalers, inhalers and methods of assembly thereof ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for fluticasone propionate

Supplementary Protection Certificates for fluticasone propionate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0067 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
269 Luxembourg ➤ Sign Up PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
C/GB08/026 United Kingdom ➤ Sign Up 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
C0014 France ➤ Sign Up PRODUCT NAME: FLUTICASONE FLUORATE; REG. NO/DATE: EU/1/07/434/001 20080111
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Farmers Insurance
Cantor Fitzgerald
McKinsey
Chinese Patent Office
Dow
Colorcon
Citi
Medtronic

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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