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Generated: December 19, 2018

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ASTEPRO Drug Profile

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When do Astepro patents expire, and what generic alternatives are available?

Astepro is a drug marketed by Mylan Speciality Lp and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-eight patent family members in twenty countries.

The generic ingredient in ASTEPRO is azelastine hydrochloride. There are twelve drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.

Drug patent expirations by year for ASTEPRO
Pharmacology for ASTEPRO
Synonyms for ASTEPRO
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)
Azelastine (hydrochloride)
AZELASTINE HCl
AZELASTINE HYDROCHLORIDE
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

US Patents and Regulatory Information for ASTEPRO

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 ASTEPRO azelastine hydrochloride SPRAY, METERED;NASAL 022203-001 Oct 15, 2008 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Speciality Lp ASTEPRO azelastine hydrochloride SPRAY, METERED;NASAL 022203-002 Aug 31, 2009 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Mylan Speciality Lp ASTEPRO azelastine hydrochloride SPRAY, METERED;NASAL 022203-001 Oct 15, 2008 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Mylan Speciality Lp ASTEPRO azelastine hydrochloride SPRAY, METERED;NASAL 022203-001 Oct 15, 2008 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ 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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Paragraph IV (Patent) Challenges for ASTEPRO
Drugname Dosage Strength RLD Date
➤ Subscribe Nasal Spray 205.5 mcg/spray ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for ASTEPRO

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

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Moodys
Federal Trade Commission
Chinese Patent Office
Medtronic
Chubb
Teva
Healthtrust
Cerilliant

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