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Azelastine hydrochloride; fluticasone propionate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for azelastine hydrochloride; fluticasone propionate?

Azelastine hydrochloride; fluticasone propionate is the generic ingredient in one branded drug marketed by Meda Pharms and is included in one NDA. There are four 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 forty-two patent family members in twenty-seven countries.

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

Summary for Generic Name: azelastine hydrochloride; fluticasone propionate

Tradenames:1
Patents:4
Applicants:1
NDAs:1
Drug Master File Entries: see list12
Suppliers / Packagers: see list2
Clinical Trials: see list1,172
Drug Prices:see low prices
DailyMed Link:azelastine hydrochloride; fluticasone propionate at DailyMed

Pharmacology for Ingredient: azelastine hydrochloride; fluticasone propionate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Meda Pharms
DYMISTA
azelastine hydrochloride; fluticasone propionate
SPRAY, METERED;NASAL202236-001May 1, 2012RXYesYes8,163,723*PED► SubscribeY► Subscribe
Meda Pharms
DYMISTA
azelastine hydrochloride; fluticasone propionate
SPRAY, METERED;NASAL202236-001May 1, 2012RXYesYes► Subscribe► Subscribe
Meda Pharms
DYMISTA
azelastine hydrochloride; fluticasone propionate
SPRAY, METERED;NASAL202236-001May 1, 2012RXYesYes8,168,620*PED► SubscribeY► Subscribe
Meda Pharms
DYMISTA
azelastine hydrochloride; fluticasone propionate
SPRAY, METERED;NASAL202236-001May 1, 2012RXYesYes► Subscribe► Subscribe
Meda Pharms
DYMISTA
azelastine hydrochloride; fluticasone propionate
SPRAY, METERED;NASAL202236-001May 1, 2012RXYesYes9,259,428*PED► SubscribeY► 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
8,318,709Combination of azelastine and mometasone 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
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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
United Kingdom0213739► Subscribe
Cyprus1109196► Subscribe
Canada2489427► Subscribe
Luxembourg92269► Subscribe
Israel216931► 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
1519731/01Switzerland► SubscribePRODUCT NAME: AZELASTIN + FLUTICASON; REGISTRATION NO/DATE: SWISSMEDIC 62675 06.05.2013
C0012Belgium► SubscribePRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218
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
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
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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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