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DYMISTA Drug Profile

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

This drug has forty-one patent family members in twenty-six 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
Formulation / Manufacturing:see details
Drug Prices: :see details
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, 2012RXYes8,168,620*PED► subscribeY► 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
8,937,057Combination 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
New Zealand574658► subscribe
United Kingdom2389530► subscribe
Canada2489427► 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
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
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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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