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Azelastine hydrochloride; fluticasone propionate - Generic Drug Details

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Azelastine hydrochloride; fluticasone propionate is the generic ingredient in one branded drug marketed by Meda Pharms and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-one patent family members in twenty-six 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:3
Applicants:1
NDAs:1
Drug Master File Entries: see list12
Suppliers / Packaging: see list2
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: azelastine hydrochloride; fluticasone propionate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Meda Pharms
DYMISTA
azelastine hydrochloride; fluticasone propionate
SPRAY, METERED;NASAL202236-001May 1, 2012RXYes8,163,723*PED► subscribeY► subscribe
Meda Pharms
DYMISTA
azelastine hydrochloride; fluticasone propionate
SPRAY, METERED;NASAL202236-001May 1, 2012RXYes► subscribe► subscribe
Meda Pharms
DYMISTA
azelastine hydrochloride; fluticasone propionate
SPRAY, METERED;NASAL202236-001May 1, 2012RXYes9,259,428*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
8,937,057Combination of azelastine and mometasone for nasal administration► subscribe
8,304,405Combination 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
New Zealand537246► subscribe
New Zealand574658► subscribe
MexicoPA04012666► 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
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
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
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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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