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Generated: April 24, 2019

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ARCAPTA NEOHALER Drug Profile

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When do Arcapta Neohaler patents expire, and when can generic versions of Arcapta Neohaler launch?

Arcapta Neohaler is a drug marketed by Sunovion Pharms Inc and is included in one NDA. There are five patents protecting this drug.

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

The generic ingredient in ARCAPTA NEOHALER is indacaterol maleate. One supplier is listed for this compound. Additional details are available on the indacaterol maleate profile page.

Drug patent expirations by year for ARCAPTA NEOHALER
Generic Entry Opportunity Date for ARCAPTA NEOHALER
Generic Entry Date for ARCAPTA NEOHALER*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INHALATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for ARCAPTA NEOHALER
Synonyms for ARCAPTA NEOHALER
(6-((5-fluoro-2-((3,4,5-trimethoxyphenyl)amino)pyrimidin-4-yl)amino)-2,2-dimethyl-3-oxo-2,3-dihydro-4H- pyrido(3,2-b)-1,4-oxazin-4-yl)methyl dihydrogen phosphate
2474AH
2JEC1ITX7R
435273-74-8
5-[(R)-2-(5,6-diethyl-indan-2-ylamino)-1-hydroxy-ethyl]-8-hydroxy-1H-quinolin-2-one maleate
5-{(1R)-2-[(5,6-diethyl-2,3-dihydro-1H-inden-2-yl)amino]-1-hydroxyethyl}-8-hydroxyquinolin-2(1H)-one (2Z)-but-2-enedioate
5,6-diethyl-N-[(2R)-2-hydroxy-2-(8-hydroxy-2-oxo-1,2-dihydroquinolin-5-yl)ethyl]indan-2-aminium (2Z)-3-carboxyacrylate
753498-25-8
AB0073003
AC-30121
AK163936
AKOS024464878
Arcapta neohaler (TN)
AS-10152
C24H28N2O3.C4H4O4
CHEBI:68573
CHEMBL1789842
CS-2703
D09319
Hirobriz Breezhaler
HY-14299A
I0927
Indacaterol (maleate)
Indacaterol maleate
Indacaterol maleate (JAN/USAN)
Indacaterol maleate [USAN]
Indacaterol Maleic Acid Salt
IREJFXIHXRZFER-PCBAQXHCSA-N
MolPort-035-395-723
Onbrez Breezhaler
Onbrez Inhalation Capsules
Oslif Breezhaler
Q-4501
QAB 149AFA
QAB-149 maleate
QAB-149-AFA
QAB149-AFA
S3083
SCHEMBL523627
UNII-2JEC1ITX7R

US Patents and Regulatory Information for ARCAPTA NEOHALER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sunovion Pharms Inc ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383-001 Jul 1, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sunovion Pharms Inc ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383-001 Jul 1, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Sunovion Pharms Inc ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383-001 Jul 1, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Sunovion Pharms Inc ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383-001 Jul 1, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Sunovion Pharms Inc ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383-001 Jul 1, 2011 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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Supplementary Protection Certificates for ARCAPTA NEOHALER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1267866 CA 2014 00020 Denmark ➤ Sign Up PRODUCT NAME: GLYCOPYRRONIUM ELLER ET SALT DERAF, ISAER BROMIDSALTET, I KOMBINATION MED INDACATEROL ELLER ET SALT DERAF, ISAER MALEATSALTET; REG. NO/DATE: EU/1/13/862 20130919
1183240 383 Finland ➤ Sign Up
1183240 7/2010 Austria ➤ Sign Up PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130
1183240 SZ 7/2010 Austria ➤ Sign Up PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON
1267866 92393 Luxembourg ➤ Sign Up PRODUCT NAME: GLYCOPYRRONIUM OU UN SEL DE CELUI-CI, PLUS PARTICULIEREMENT LE SEL BROMURE, COMBINE A INDACATEROL OU UN SEL DE CELUI-CI, PLUS PARTICULIEREMENT LE SEL MALEATE. FIRST REGISTRATION: 20130923
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
AstraZeneca
Colorcon
UBS
Harvard Business School
Covington

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