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DYMISTA Drug Profile

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Which patents cover Dymista, and what substitute generic drugs are available?

Dymista is a drug marketed by Meda Pharms and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has forty-two patent family members in twenty-seven countries.

The generic ingredient in DYMISTA is azelastine hydrochloride; fluticasone propionate. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.

Summary for Tradename: DYMISTA

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Clinical Trials: see list6
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:DYMISTA at DailyMed
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, 2012RXYesYes9,259,428*PED► SubscribeY► Subscribe
Meda Pharms
DYMISTA
azelastine hydrochloride; fluticasone propionate
SPRAY, METERED;NASAL202236-001May 1, 2012RXYesYes► Subscribe► Subscribe
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Paragraph IV activity for: DYMISTA

Drugname Dosage Strength RLD Submissiondate
azelastine hydrochloride and fluticasone propionateNasal Spray137 mcg/50 mcg per sprayDymista6/13/2014

Non-Orange Book Patents for Tradename: DYMISTA

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 Tradename: DYMISTA

Country Document Number Estimated Expiration
European Patent Office1519731► Subscribe
World Intellectual Property Organization (WIPO)03105856► Subscribe
Canada2779630► Subscribe
South Korea101301558► Subscribe
Israel165771► 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: DYMISTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013 00023Denmark► Subscribe
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
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
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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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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