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Last Updated: May 7, 2024

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^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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

US Patents and Regulatory Information for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

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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	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>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	⤷ Try a Trial	⤷ Try a Trial
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	⤷ Try a Trial	⤷ Try a Trial
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	⤷ Try a Trial	⤷ Try a Trial
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	⤷ Try a Trial	⤷ Try a Trial
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	⤷ Try a Trial	⤷ Try a Trial
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	⤷ Try a Trial	⤷ Try a Trial
>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
Canada	2506082	NOUVEAUX MEDICAMENTS DESTINES AU TRAITEMENT DE LA BRONCHOPNEUMOPATHIE CHRONIQUE OBSTRUCTIVE (NOVEL MEDICAMENTS FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASES)	⤷ Try a Trial
South Africa	200607152	Novel enantiomerically pure beta-agonists, method for the production and the use thereof in the form of a drug	⤷ Try a Trial
Malaysia	136034	NEW MEDICAMENTS FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE	⤷ Try a Trial
Israel	167102	BLOCKING DEVICE FOR A SPRUNG LOCK WITH A SPRING OPERATION	⤷ Try a Trial
Serbia	51607	NOVI LEKOVI ZA TRETIRANJE HRONIČNOG OPSTRUKTIVNOG OBOLJENJA PLUĆA (NOVEL MEDICAMENT FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASES)	⤷ Try a Trial
Norway	20060412		⤷ Try a Trial
>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	159 5009-2014	Slovakia	⤷ Try a Trial	PRODUCT NAME: OLODATEROL HYDROCHLORID; NAT. REGISTRATION NO/DATE: 14/0394/13-S 20131029; FIRST REGISTRATION: MT MA211/00401 20130918
1562603	C 2014 025	Romania	⤷ Try a Trial	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	⤷ Try a Trial	PRODUCT NAME: OLODATEROL; REGISTRATION NO/DATE: SWISSMEDIC 62880 12.05.2014
1562603	1490016-1	Sweden	⤷ Try a Trial	PRODUCT NAME: OLODATEROL, INDIVIDUELLA OPTISKA ISOMERER DAERAV, BLANDNINGAR AV DE SEPARATA ENANTIOMERERNA ELLER RACEMATEN DAERAV, SYRA ADDITIONSSALTER DAERAV MED FARMAKOLOGISKT GODTAGBARA SYROR SAVAEL SOM SOLVATER OCH/ELLER HYDRATER DAERAV, SAERSKILT OLODATEROL OCH OLODATEROLHYDROKLORID; NAT. REG. NO/DATE: MT-NR 48116 20131114; FIRST REG.: MT MA 211/00401 20130918
1562603	CR 2014 00014	Denmark	⤷ Try a Trial	PRODUCT NAME: OLODATEROL, OPTISKE ISOMERER DERAF, BLANDINGER AF ISOMERER DERAF, SYREADDITIONSSALTE DERAF MED FARMAKOLGISK HARMLOESE SYRER, SAVEL SOM SOLVATER OG/ELLER HYDRATER DERAF, SAERLIGT OLODATEROL OG OLODATEROL HYDROCHLORID; NAT. REG. NO/DATE: 50975 20131014; FIRST REG. NO/DATE: MA 211/00401 20130918
1562603	21/2014	Austria	⤷ Try a Trial	PRODUCT NAME: OLODATEROL, DESSEN SAEUREHAELTIGEN SALZE MIT PHARMAKOLOGISCH VERTRAEGLICHEN SAEUREN, IM BESONDEREN OLODATEROL HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 135232 20131125; FIRST REGISTRATION: MT MA211/00401 20130918
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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 verification 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.