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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Cantor Fitzgerald
McKesson
Chubb
Federal Trade Commission
Teva
Harvard Business School
Moodys
Baxter

Generated: April 26, 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.
Summary for azelastine hydrochloride; fluticasone propionate
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 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
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
8,933,060 Combination of azelastine and ciclesonide for nasal administration ➤ Sign Up
8,937,057 Combination of azelastine and mometasone for nasal administration ➤ Sign Up
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
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
90033-7 Sweden ➤ Sign Up PRODUCT 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
2013023 Lithuania ➤ Sign Up PRODUCT NAME: AZELASTINUM HYDROCHLORICUM + FLUTICASONUM PROPIONICUM; REGISTRATION NO/DATE: LT/1/13/3227/001 - LT/1 3/3227/004
C0067 France ➤ Sign Up PRODUCT 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
0130025 00090 Estonia ➤ Sign Up PRODUCT NAME: FLUTIKASOON; ASELASTIIN;REG NO/DATE: EE 808513 04.03.2013
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Deloitte
Mallinckrodt
McKesson
Teva
QuintilesIMS
Boehringer Ingelheim
McKinsey

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.