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Serving leading biopharmaceutical companies globally:

Cipla
US Army
Cerilliant
Medtronic
Dow
Express Scripts
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Covington
Chinese Patent Office
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Generated: November 20, 2017

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Azelastine hydrochloride; fluticasone propionate - Generic Drug Details

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

Azelastine hydrochloride; fluticasone propionate
is the generic ingredient in two branded drugs marketed by Apotex Inc and Mylan Speciality Lp, and is included in two NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Azelastine hydrochloride; fluticasone propionate has fifty-four patent family members in twenty-seven countries and ten supplementary protection certificates in ten countries.

There are twelve drug master file entries for azelastine hydrochloride; fluticasone propionate. Two suppliers are listed for this compound.

Summary for azelastine hydrochloride; fluticasone propionate

Pharmacology for azelastine hydrochloride; fluticasone propionate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Speciality Lp
DYMISTA
azelastine hydrochloride; fluticasone propionate
SPRAY, METERED;NASAL202236-001May 1, 2012ABRXYesYes► Subscribe► Subscribe► Subscribe
Mylan Speciality Lp
DYMISTA
azelastine hydrochloride; fluticasone propionate
SPRAY, METERED;NASAL202236-001May 1, 2012ABRXYesYes► Subscribe► SubscribeY► Subscribe
Mylan Speciality Lp
DYMISTA
azelastine hydrochloride; fluticasone propionate
SPRAY, METERED;NASAL202236-001May 1, 2012ABRXYesYes► Subscribe► Subscribe► Subscribe
Mylan Speciality Lp
DYMISTA
azelastine hydrochloride; fluticasone propionate
SPRAY, METERED;NASAL202236-001May 1, 2012ABRXYesYes► Subscribe► SubscribeY► Subscribe
Mylan Speciality Lp
DYMISTA
azelastine hydrochloride; fluticasone propionate
SPRAY, METERED;NASAL202236-001May 1, 2012ABRXYesYes► Subscribe► SubscribeY► Subscribe
Apotex Inc
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
azelastine hydrochloride; fluticasone propionate
SPRAY, METERED;NASAL207712-001Apr 28, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: azelastine hydrochloride; 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
8,304,405Combination of azelastine and ciclesonide for nasal administration► Subscribe
8,937,057Combination of azelastine and mometasone for nasal administration► Subscribe
8,933,060Combination of azelastine and ciclesonide for nasal administration► Subscribe
8,318,709Combination of azelastine and mometasone for nasal administration► 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: azelastine hydrochloride; fluticasone propionate

Country Document Number Estimated Expiration
Denmark2072051► Subscribe
European Patent Office1519731► Subscribe
Slovenia2072051► Subscribe
New Zealand574658► Subscribe
Denmark1519731► Subscribe
Portugal2072051► Subscribe
United Kingdom0213739► Subscribe
HungaryE027184► Subscribe
HungaryS1300032► Subscribe
South Korea20110113782► 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: AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90033-7Sweden► SubscribePRODUCT NAME: AZELASTIN, ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV, OCH EN FARMACEUTISKT GODTAGBAR ESTER AV FLUTIKASON; NAT. REG. NO/DATE: MTNR 47084 20130221; FIRST REG.: SK 24/0055/13-S 20130215
269Luxembourg► SubscribePRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
00740Netherlands► SubscribePRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
0130025 00090Estonia► SubscribePRODUCT NAME: FLUTIKASOON; ASELASTIIN;REG NO/DATE: EE 808513 04.03.2013
2013 00023Denmark► Subscribe
1519731/01Switzerland► SubscribePRODUCT NAME: AZELASTIN + FLUTICASON; REGISTRATION NO/DATE: SWISSMEDIC 62675 06.05.2013
5 5006-2013Slovakia► SubscribePRODUCT NAME: AZELASTIN ALEBO JEHO FARMACEUTICKY PRIJATE LNE SOLI A FARMACEUTICKY PRIJATEL NY ESTER FLUTIKAZONU; REGISTRATION NO/DATE: 24/0055/13-S 20130215
2013023Lithuania► SubscribePRODUCT NAME: AZELASTINUM HYDROCHLORICUM + FLUTICASONUM PROPIONICUM; REGISTRATION NO/DATE: LT/1/13/3227/001 - LT/1 3/3227/004
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
C0012Belgium► SubscribePRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Farmers Insurance
US Department of Justice
Teva
Merck
Chinese Patent Office
Express Scripts
Medtronic
Colorcon
Covington
Fuji

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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