➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Merck
Baxter
AstraZeneca
Dow

Last Updated: September 21, 2021

DrugPatentWatch Database Preview

FLUTICASONE PROPIONATE - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing

« Back to Dashboard

What are the generic sources for fluticasone propionate and what is the scope of freedom to operate?

Fluticasone propionate is the generic ingredient in twenty branded drugs marketed by Glaxosmithkline, Glaxo Grp Ltd, Fougera Pharms, Anda Repository, Cosette, Nesher Pharms, Perrigo Israel, Glenmark Generics, Taro Pharm Inds, Teva Pharm, Glaxosmithkline Cons, Akorn, Apotex, Apotex Inc, Hikma, Wockhardt Bio Ag, Optinose Us Inc, and Mylan, and is included in thirty-four NDAs. There are fifty-six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fluticasone propionate has seven hundred and fifty-nine patent family members in forty countries.

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

Drug Prices for FLUTICASONE PROPIONATE

See drug prices for FLUTICASONE PROPIONATE

Drug Sales Revenue Trends for FLUTICASONE PROPIONATE

See drug sales revenues for FLUTICASONE PROPIONATE

Recent Clinical Trials for FLUTICASONE PROPIONATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Assistance Publique - Hôpitaux de ParisPhase 3
PARZIBUT GillesPhase 4
St. Paul's Sinus CentrePhase 4

See all FLUTICASONE PROPIONATE clinical trials

Pharmacology for FLUTICASONE PROPIONATE
Paragraph IV (Patent) Challenges for FLUTICASONE PROPIONATE
Tradename Dosage Ingredient NDA Submissiondate
FLOVENT HFA AEROSOL, METERED;INHALATION fluticasone propionate 021433 2016-12-23
CUTIVATE LOTION;TOPICAL fluticasone propionate 021152 2008-07-28

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
Teva Pharm ARMONAIR RESPICLICK fluticasone propionate POWDER;INHALATION 208798-007 Jul 9, 2021 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Teva Pharm AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-006 Jul 12, 2019 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Teva Pharm ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-006 Feb 20, 2020 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Teva Pharm ARMONAIR RESPICLICK fluticasone propionate POWDER;INHALATION 208798-002 Jan 27, 2017 DISCN Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Teva Pharm ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-006 Feb 20, 2020 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Teva Pharm AIRDUO DIGIHALER fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 208799-005 Jul 12, 2019 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Pharm ARMONAIR RESPICLICK fluticasone propionate POWDER;INHALATION 208798-003 Jan 27, 2017 ⤷  Try it Free ⤷  Try it Free
Glaxosmithkline FLOVENT fluticasone propionate POWDER;INHALATION 020549-003 Nov 7, 1997 ⤷  Try it Free ⤷  Try it Free
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-001 May 14, 2004 ⤷  Try it Free ⤷  Try it Free
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-003 May 14, 2004 ⤷  Try it Free ⤷  Try it Free
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-002 May 14, 2004 ⤷  Try it Free ⤷  Try it Free
Teva Pharm ARMONAIR RESPICLICK fluticasone propionate POWDER;INHALATION 208798-003 Jan 27, 2017 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for FLUTICASONE PROPIONATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1519731 13C0067 France ⤷  Try it Free 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 132018000000341 Italy ⤷  Try it Free PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117
2506844 18C1022 France ⤷  Try it Free 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
1305329 SPC/GB08/026 United Kingdom ⤷  Try it Free 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
2506844 LUC00077 Luxembourg ⤷  Try it Free PRODUCT NAME: PRODUIT DE COMBINAISON PHARMACEUTIQUE COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (PAR EXEMPLE LE BROMURE D'UMECLIDINIUM), LE VILANTEROL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE (PAR EXEMPLE LE TRIFENATATE DE VILANTEROL) ET LE FUROATE DE FLUTICASONE; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
1519731 132013902182575 Italy ⤷  Try it Free 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Merck
Baxter
AstraZeneca
Dow

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.