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Last Updated: June 6, 2020

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Azelastine hydrochloride - Generic Drug Details

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What are the generic drug sources for azelastine hydrochloride and what is the scope of freedom to operate?

Azelastine hydrochloride is the generic ingredient in six branded drugs marketed by Akorn, Alembic Pharms Ltd, Apotex Inc, Gland Pharma Ltd, Sandoz Inc, Somerset Theraps Llc, Sun Pharm, Mylan Speciality Lp, Alkem Labs Ltd, Amneal Pharms Llc, Aurobindo Pharma Ltd, Breckenridge, Hi Tech, Hikma, Perrigo Israel, Upsher Smith Labs, Zydus Pharms, and Apotex, and is included in twenty-seven NDAs. There are seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Azelastine hydrochloride has forty-nine patent family members in twenty-three countries.

There are twelve drug master file entries for azelastine hydrochloride. Twenty-one suppliers are listed for this compound.

Pharmacology for azelastine hydrochloride
Paragraph IV (Patent) Challenges for AZELASTINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
ASTEPRO SPRAY, METERED;NASAL azelastine hydrochloride 022203 2011-12-15
OPTIVAR SOLUTION/DROPS;OPHTHALMIC azelastine hydrochloride 021127 2006-12-13
ASTELIN SPRAY, METERED;NASAL azelastine hydrochloride 020114 2005-11-14

US Patents and Regulatory Information for azelastine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz Inc AZELASTINE HYDROCHLORIDE azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 202305-001 May 31, 2012 AT RX No Yes   Start Trial   Start Trial   Start Trial
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Hikma AZELASTINE HYDROCHLORIDE azelastine hydrochloride SPRAY, METERED;NASAL 091444-001 Oct 24, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Zydus Pharms AZELASTINE HYDROCHLORIDE azelastine hydrochloride SPRAY, METERED;NASAL 091409-001 Aug 14, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Gland Pharma Ltd AZELASTINE HYDROCHLORIDE azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 210092-001 Feb 25, 2020 AT RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for azelastine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp OPTIVAR azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021127-001 May 22, 2000   Start Trial   Start Trial
Mylan Speciality Lp ASTELIN azelastine hydrochloride SPRAY, METERED;NASAL 020114-001 Nov 1, 1996   Start Trial   Start Trial
Mylan Speciality Lp OPTIVAR azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021127-001 May 22, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for azelastine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1519731 13C0067 France   Start 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
0316633 99C0012 Belgium   Start Trial PRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218
1519731 C300740 Netherlands   Start Trial PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
1519731 92269 Luxembourg   Start Trial PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Medtronic
Boehringer Ingelheim
Express Scripts
Merck
McKesson

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 verification 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.