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Generated: July 21, 2018

DrugPatentWatch Database Preview

AZELASTINE HYDROCHLORIDE - Generic Drug Details

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

Azelastine hydrochloride
is the generic ingredient in six branded drugs marketed by Akorn, Apotex Inc, Sandoz Inc, Sun Pharma Global, Mylan Speciality Lp, Alkem Labs Ltd, Amneal Pharms Llc, Breckenridge Pharm, Perrigo Israel, Upsher-smith Labs, West-ward Pharms Int, and Zydus Pharms Usa Inc, and is included in twenty-one 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 thirty-eight patent family members in twenty countries.

There are twelve drug master file entries for azelastine hydrochloride. Seventeen suppliers are listed for this compound. There is one tentative approval for this compound.
Pharmacology for AZELASTINE HYDROCHLORIDE
Synonyms for AZELASTINE HYDROCHLORIDE
1(2H)-Phthalazinone, 4-((4-chlorophenyl)methyl)-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride
1(2H)-Phthalazinone, 4-((4-chlorophenyl)methyl)-2-(hexahydro-1-methyl-1H-azepin-4-yl)-,monohydrochloride
1(2H)-Phthalazinone,4-[(4-chlorophenyl)methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-,hydrochloride (1:?)
307A930
37932-96-0
4-((4-Chlorophenyl)methyl)-2-(hexahydro-1-methyl-1H-azepin-4-yl)phthalazin-1(2H)-one hydrochloride
4-(4-Chlorobenzyl)-2-(1-methylazepan-4-yl)-1-phthalazinone Hydrochloride
4-(4-chlorobenzyl)-2-(1-methylazepan-4-yl)phthalazin-1(2H)-one hydrochloride
4-(p-Chlorobenzyl)-2-(hexahydro-1-methyl-1H-azepin-4-yl)-1(2H)-phthalazinone monohydrochloride
4-[ methyl]-2- phthalazin-1 -onehydrochloride
4-[(4-Chlorophenyl)methyl]-2-(1-methyl-4-azepanyl)phthalazin-1-one Hydrochloride
4-[(4-chlorophenyl)methyl]-2-(1-methylazepan-4-yl)phthalazin-1-one hydrochloride
4-[(4-chlorophenyl)methyl]-2-(1-methylazepan-4-yl)phthalazin-1-one;hydrochloride
4-[(4-CHLOROPHENYL)METHYL]-2-(HEXAHYDRO-1-METHYL-1H-AZEPIN-4-YL)PHTHALAZIN-1(2H)-ONE HYDROCHLORIDE
58581-89-8 (Parent)
79307-93-0
A 5610
A-5610
AB2000649
AC-5498
AC1L1GV0
ACM37932960
AKOS015895420
Allergodil
Allergodil;Rhinolast;Astelin;Optilas;Optivar
AN-10917
API0001572
AS-14079
Astelin
Astelin (TN)
Astepro
Azelastine (hydrochloride)
AZELASTINE HCl
Azelastine hydrochloride (Astelin)
Azelastine hydrochloride (JP17/USAN)
Azelastine hydrochloride [USAN:JAN]
Azelastine Hydrochloride 1.0 mg/ml in Methanol (as free base)
Azelastine hydrochloride, >=98% (HPLC)
Azelastine hydrochloride, European Pharmacopoeia (EP) Reference Standard
Azelastine Hydrochloride, pharmaceutical secondary standard; traceable to USP, PhEur
Azelastine hydrochloride, United States Pharmacopeia (USP) Reference Standard
Azelastine monohydrochloride
Azep
Azeptin
BCP0726000233
BCP9000369
BCPP000358
C22H24ClN3O.HCl
CAS-79307-93-0
CCG-100841
CCG-40046
CHEBI:2951
CHEMBL1200809
Corifina
CPD000469183
CS-2573
CTK4H9031
D00659
DSSTox_CID_25945
DSSTox_GSID_45945
DSSTox_RID_81243
DTXSID2045945
E-0659
EINECS 253-720-4
HE199844
HE199845
HMS1922F04
HY-B0462
I06-0528
J90045
LS-109215
MFCD00242783
MLS001401427
MLS006010756
MolPort-003-666-641
NC00091
NCGC00095173-01
NCGC00095173-02
NCGC00177979-05
NSC-758971
NSC758971
Optilas
Optilast
Optivar
Pharmakon1600-01505340
PubChem20750
Radethazin
Rhinolast
S2552
SAM001246645
SCHEMBL36770
SMR000469183
SPECTRUM1505340
ST51052784
Tox21_111469
Tox21_111469_1
W- 979M
W-2979M
YEJAJYAHJQIWNU-UHFFFAOYSA-N
Zalastine
Tentative approvals for AZELASTINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign UpEQ 0.1876MG BASE/SPRAYSPRAY, METERED;NASAL

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
Apotex Inc AZELASTINE HYDROCHLORIDE azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 078621-001 Aug 3, 2009 AT RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Inc AZELASTINE HYDROCHLORIDE azelastine hydrochloride SPRAY, METERED;NASAL 201846-001 Aug 31, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Speciality Lp ASTEPRO azelastine hydrochloride SPRAY, METERED;NASAL 022203-002 Aug 31, 2009 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
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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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 ➤ Sign Up ➤ Sign Up
Mylan Speciality Lp ASTELIN azelastine hydrochloride SPRAY, METERED;NASAL 020114-001 Nov 1, 1996 ➤ Sign Up ➤ Sign Up
Mylan Speciality Lp OPTIVAR azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021127-001 May 22, 2000 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for AZELASTINE HYDROCHLORIDE

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
8,758,816 Compositions comprising azelastine and methods of use thereof ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for AZELASTINE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
269 Luxembourg ➤ Sign Up PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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
00740 Netherlands ➤ Sign Up PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Fish and Richardson
Federal Trade Commission
Medtronic
Deloitte
AstraZeneca
Chubb
Accenture
McKinsey

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