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Fish and Richardson
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Generated: December 11, 2018

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Azelastine hydrochloride; fluticasone propionate - Generic Drug Details

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What are the generic drug 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
Apotex Inc AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 207712-001 Apr 28, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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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Supplementary Protection Certificates for azelastine hydrochloride; fluticasone propionate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0012 Belgium ➤ Try a Free Trial PRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218
C0067 France ➤ Try a Free Trial 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
5 5006-2013 Slovakia ➤ Try a Free Trial PRODUCT NAME: AZELASTIN ALEBO JEHO FARMACEUTICKY PRIJATE LNE SOLI A FARMACEUTICKY PRIJATEL NY ESTER FLUTIKAZONU; REGISTRATION NO/DATE: 24/0055/13-S 20130215
90033-7 Sweden ➤ Try a Free Trial 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Chubb
Farmers Insurance
McKesson
Queensland Health
Baxter
Boehringer Ingelheim
QuintilesIMS
Express Scripts

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