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Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206756

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NDA 206756 describes STIOLTO RESPIMAT, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are nineteen patents protecting this drug. Additional details are available on the STIOLTO RESPIMAT profile page.

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 206756

Tradename:	STIOLTO RESPIMAT
Applicant:	Boehringer Ingelheim
Ingredient:	olodaterol hydrochloride; tiotropium bromide
Patents:	19

Pharmacology for NDA: 206756

Mechanism of Action	Cholinergic Antagonists Adrenergic beta2-Agonists

Suppliers and Packaging for NDA: 206756

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756	NDA	Boehringer Ingelheim Pharmaceuticals Inc.	0597-0155	N	0597-0155-61
STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756	NDA	Boehringer Ingelheim Pharmaceuticals Inc.	0597-0155	N	0597-0155-28

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY, METERED;INHALATION			Strength	EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH
Approval Date:	May 21, 2015	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Mar 18, 2019
Regulatory Exclusivity Use:	INFORMATION ADDED TO THE CLINICAL STUDIES SECTION OF THE LABELING DESCRIBING THE EFFECTS OF STIOLTO RESPIMAT ON COPD PATIENTS
Regulatory Exclusivity Expiration:	Jul 31, 2019
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:	May 21, 2018
Regulatory Exclusivity Use:	NEW COMBINATION

Expired US Patents for NDA 206756

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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

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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 verifification 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.