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Last Updated: June 2, 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 freedom to operate?

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

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	⤷ 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			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	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
>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
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
South Africa	200607152	Novel enantiomerically pure beta-agonists, method for the production and the use thereof in the form of a drug	⤷ Sign Up
European Patent Office	1426662	Pompe à piston (Piston pump)	⤷ Sign Up
Argentina	041060	DISPOSITIVO BLOQUEADOR PARA UN MECANISMO TENSOR DE BLOQUEO CON UNA TOMA DE FUERZA ACCIONADA POR RESORTE	⤷ Sign Up
Norway	334314		⤷ Sign Up
South Africa	200604658	Device for holding a fluidic component	⤷ 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	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
1562603	21/2014	Austria	⤷ Sign Up	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
1562603	132014902316088	Italy	⤷ Sign Up	PRODUCT NAME: OLODATEROLO, SUOI SINGOLI ISOMERI OTTICI, MISCELE DEI SINGOLI ENANTIOMERI O DI RACEMATI, SUOI SALI DI ADDIZIONE CON ACIDI FARMACOLOGICAMENTE ACCETTABILI NONCHE' SUOI SOLVATI E/O IDRATI, IN PARTICOLARE OLODATEROLO E OLODATEROLO CLORIDRATO(STRIVERDI RESPIMAT); AUTHORISATION NUMBER(S) AND DATE(S): MA211/00401, 20130918;042432017-029-031-043, 20140618
1562603	CR 2014 00014	Denmark	⤷ Sign Up	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	300650	Netherlands	⤷ Sign Up	PRODUCT NAME: OLODATEROL, HET R-ENANTIOMEER DAARVAN, MENGSELS VAN ISOMEREN DAARVAN, ZUURADDITIEZOUTEN MET FARMACOLOGISCH AANVAARDBARE ZUREN DAARVAN, EVENALS SOLVATEN EN/OF HYDRATEN DAARVAN, IN HET BIJZONDER OLODATEROL EN OLODATEROLHYDROCHLORIDE; REGISTRATION NO/DATE: RVG 112058 20131023
>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.