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Last Updated: August 14, 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				⤷ 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			⤷ 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
>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
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
Montenegro	00354	NOVI LEKOVI ZA TRETIRANJE HRONIĆNOG OPSTRUKTIVNOG OBOLJENJA PLUĆA (NOVEL MEDICAMENTS FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASES)	⤷ Sign Up
Denmark	1539368		⤷ Sign Up
Taiwan	200423943	New medicaments for the treatment of chronic obstructive pulmonary disease	⤷ Sign Up
Ecuador	SP056234	BOQUILLA MICROESTRUCTURADA DE ALTA PRESIÓN CON FUNCIÓN DE FILTRO INCORPORADA	⤷ Sign Up
China	1921949	Device for holding a fluidic component	⤷ Sign Up
Lithuania	C1562603		⤷ Sign Up
South Africa	200500083	Blocking device for sprung lock with a spring operation	⤷ 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	122014000018	Germany	⤷ Sign Up	PRODUCT NAME: OLODATEROL, OPTISCHE ISOMERE DAVON, MISCHUNGEN VON ISOMEREN DAVON, SAEUREADDITIONSSALZE DAVON MIT PHARMAKOLOGISCH UNBEDENKLICHEN SAEUREN, SOWIE SOLVATE UND/ODER HYDRATE DAVON, INSBESONDERE OLODATEROL UND OLODATEROLHYDROCHLORID; NAT. REGISTRATION NO/DATE: 87146.00.00 20131126; FIRST REGISTRATION: MALTA MA 211/00401 20130918
1562603	C20140010 00101	Estonia	⤷ Sign Up	PRODUCT NAME: OLODATEROOL;REG NO/DATE: EE 825513 03.10.2013
1562603	PA2014012	Lithuania	⤷ Sign Up	PRODUCT NAME: OLODATEROLUM; REGISTRATION NO/DATE: LT/1/13/3429/001 LT/1/13/3429/003 LT/1/13/3429/003 LT/1/13/3429/004 20131031
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	14C0049	France	⤷ Sign Up	PRODUCT NAME: OLODATEROL, SES ISOMERES OPTIQUES INDIVIDUELS, MELANGES D'ENANTIOMERES INDIVIDUELS OU RACEMATE, SES SELS D'ADDITION D'ACIDE AVEC DES ACIDES PHARMACOLOGIQUEMENT ACCEPTABLES, AINSI QUE DES SOLVATES ET OU HYDRATES, EN PARTICULIER OLODATEROL OU CHLORHYDRATE D'OLODATEROL; NAT. REGISTRATION NO/DATE: NL42395 20140522; FIRST REGISTRATION: MT - MA211/00401 20130918
1562603	92433	Luxembourg	⤷ Sign Up	PRODUCT NAME: OLODATEROL,SES ISOMERES OPTIQUES INDIVIDUELS,MELANGES D ENANTIOMERES INDIVIDUELS OU DE RACEMATES,SES SELS D ADDITION D ACIDE AVEC DES ACIDES PHARMACEUTIQUEMENT ACCEPTABLES,AINSI QUE SES SOLVATES ET/OU SES HYDRATES,EN PARTICULIER L OLODATEROL ET LE CHLORHYDRATE D OLODATEROL
1562603	1490016-1	Sweden	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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