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STIOLTO RESPIMAT Drug Profile

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When do Stiolto Respimat patents expire, and what generic alternatives are available?

Stiolto Respimat is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are eighteen patents protecting this drug.

This drug has three hundred and forty-nine patent family members in forty-eight countries.

The generic ingredient in STIOLTO RESPIMAT is olodaterol hydrochloride; tiotropium bromide. One supplier is listed for this compound. Additional details are available on the olodaterol hydrochloride; tiotropium bromide profile page.

Summary for STIOLTO RESPIMAT

International Patents:	349
US Patents:	18
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Clinical Trials:	3
Drug Prices:	Drug price information for STIOLTO RESPIMAT
Prior Art and Litigation Support	Order Prior Art and Litigation support for STIOLTO RESPIMAT
DailyMed Link:	STIOLTO RESPIMAT at DailyMed

Generic Entry Opportunity Date for STIOLTO RESPIMAT

NDA:

206756

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 STIOLTO RESPIMAT

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

Synonyms for STIOLTO RESPIMAT

1589477-29-1

Olodaterol / tiotropium

Olodaterol / tiotropium bromide

Olodaterol mixture with tiotropium bromide

Tiotropium / Olodaterol

US Patents and Regulatory Information for STIOLTO RESPIMAT

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			Y	Y
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes					Y
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes			Y	Y
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes				Y
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes

Expired US Patents for STIOLTO RESPIMAT

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
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015

International Patents for STIOLTO RESPIMAT

Country	Patent Number	Estimated Expiration
Japan	2006509153
South Africa	200500083
Spain	2357570
European Patent Office	1772175
Germany	102004001451
Brazil	0313816

Supplementary Protection Certificates for STIOLTO RESPIMAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1562603	122014000018	Germany		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	2014/016	Ireland		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		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	PA2014012	Lithuania		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	CR 2014 00014	Denmark		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	14C0049	France		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