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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Queensland Health
US Army
Dow
Cerilliant
Boehringer Ingelheim
US Department of Justice
QuintilesIMS
Daiichi Sankyo

Generated: July 21, 2018

DrugPatentWatch Database Preview

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 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 fifty-four 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.
Pharmacology for azelastine hydrochloride; fluticasone propionate

US Patents and Regulatory Information 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;NASAL 202236-001 May 1, 2012 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Inc AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 207712-001 Apr 28, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
8,304,405 Combination of azelastine and ciclesonide for nasal administration ➤ Sign Up
8,318,709 Combination of azelastine and mometasone for nasal administration ➤ Sign Up
8,933,060 Combination of azelastine and ciclesonide for nasal administration ➤ Sign Up
8,937,057 Combination of azelastine and mometasone for nasal administration ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for azelastine hydrochloride; fluticasone propionate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013 00023 Denmark ➤ Sign Up
00740 Netherlands ➤ Sign Up PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
0130025 00090 Estonia ➤ Sign Up PRODUCT NAME: FLUTIKASOON; ASELASTIIN;REG NO/DATE: EE 808513 04.03.2013
C0012 Belgium ➤ Sign Up PRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Argus Health
Accenture
Harvard Business School
Queensland Health
Citi
Baxter
Mallinckrodt
Johnson and Johnson

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.