OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE - Generic Drug Details

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What are the generic drug sources for olodaterol hydrochloride; tiotropium bromide and what is the scope of patent protection?

Olodaterol hydrochloride; tiotropium bromide is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Olodaterol hydrochloride; tiotropium bromide has one hundred and ninety-four patent family members in forty countries.

One supplier is listed for this compound.

Summary for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

International Patents:	194
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
DailyMed Link:	OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

Generic Entry Date for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: SPRAY, METERED;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 OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

Drug Class	Anticholinergic beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Cholinergic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

Paragraph IV (Patent) Challenges for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
STIOLTO RESPIMAT	Inhalation Spray	olodaterol hydrochloride; tiotropium bromide	2.5 mcg/2.5 mcg per spray	206756	1	2024-05-24

US Patents and Regulatory Information for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		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

Expired US Patents for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

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Country	Patent Number	Title	Estimated Expiration
Colombia	5700803	BOQUILLA MICROESTRUCTURADA DE ALTA PRESION CON FUNCION DE FILTRO INCORPORADA	⤷ Sign Up
European Patent Office	1641569	AJUTAGE HAUTE PRESSION MICROSTRUCTURE COMPORTANT UNE FONCTION DE FILTRAGE INTEGREE (MICROSTRUCTURED HIGH PRESSURE NOZZLE WITH AN IN-BUILT FILTER FUNCTION)	⤷ Sign Up
Peru	20050026	BOQUILLA MICROESTRUCTURADA DE ALTA PRESION CON FUNCION DE FILTRO INCORPORADA	⤷ Sign Up
Brazil	PI0412043	bocal de alta pressão microestruturado com função de filtro embutida	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1562603	PA2014012,C1562603	Lithuania	⤷ Sign Up	PRODUCT NAME: OLODATEROLIS, JO OPTINIAI IZOMERAI, JO ATSKIRU ENANTIOMERU ARBA RACEMATU MISINIAI, JO RUGSTIES ADITYVINES DRUSKOS SU FRAMAKOLOGINIU POZIURIU PRIIMTINOMIS RUGSTIMIS, O TAIP PAT JO SOLVATAI IR/ARBA HIDRATAI, KONKRECIAI OLODATEROLIS IR OLODATEROLIO CHLORIDAS; NAT. REGISTRATION NO/DATE: LT/1/13/3429/001, LT/1/13/3429/002, LT/1/13/3429/003, LT/1/13/3429/004 20131031; FIRST REGISTRATION: MA211/00401 20130918
1562603	C 2014 025	Romania	⤷ Sign Up	PRODUCT NAME: OLODATEROL, IZOMERI OPTICI INDIVIDUALI AI ACESTUIA,AMESTECURI DE ENANTIOMERI INDIVIDUALI SAU RACEMATI, SARURILE DE ADITIE ACIDA ALE ACESTORA CU ACIZI ACCEPTABILIFARMACOLOGIC, CA SI SOLVATI SI/SAU HIDRATI AI ACESTORA, IN SPECIAL OLODATEROL SI CLORHI DRAT DE OLODATEROL -6-HIDROXI-2-{[1-(4-METOXIFENIL)-1,1-DIMETILETIL]AMINO}ETIL]-2H-1,4-BENZOXAZIN-3(4H)-ONA(CACLORHIDRAT); NATIONAL AUTHORISATION NUMBER: 6414/2014/01, 6414/2014/02, 6414/2014/03, 6414/2014/04; DATE OF NATIONAL AUTHORISATION: 20140507; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): MA211/00401; DATE OF FIRST AUTHORISATION IN EEA: 20130918
1562603	C01562603/01	Switzerland	⤷ Sign Up	PRODUCT NAME: OLODATEROL; REGISTRATION NO/DATE: SWISSMEDIC 62880 12.05.2014
1562603	2014/016	Ireland	⤷ Sign Up	PRODUCT NAME: OLODATEROL, OPTICAL ISOMERS THEREOF, MIXTURES OF ISOMERS THEREOF, ACID ADDITION SALTS THEREOF WITH PHARMACOLOGICALLY ACCEPTABLE ACIDS, AS WELL AS SOLVATES AND/OR HYDRATES THEREOF, IN PARTICULAR OLODATEROL AND OLODATEROL HYDROCHLORIDE.; NAT REGISTRATION NO/DATE: PA0775/006/001 20131018; FIRST REGISTRATION NO/DATE: MA211/00401 20130918
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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