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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
US Army
Queensland Health
Mallinckrodt
Boehringer Ingelheim
Dow
Chinese Patent Office
Citi
Harvard Business School

Generated: June 25, 2018

DrugPatentWatch Database Preview

ASTEPRO Drug Profile

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Which patents cover Astepro, 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 ➤ 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 ASTEPRO azelastine hydrochloride SPRAY, METERED;NASAL 022203-001 Oct 15, 2008 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Mylan Speciality Lp ASTEPRO azelastine hydrochloride SPRAY, METERED;NASAL 022203-001 Oct 15, 2008 DISCN No No ➤ 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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Paragraph IV (Patent) Challenges for ASTEPRO
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Nasal Spray 205.5 mcg/spray ➤ Subscribe 2011-12-15

Non-Orange Book US Patents for ASTEPRO

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 ASTEPRO

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
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
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
McKinsey
Argus Health
Dow
Deloitte
Citi
Johnson and Johnson
Chinese Patent Office
Chubb

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.