Details for New Drug Application (NDA): 203108

NDA 203108 describes STRIVERDI RESPIMAT, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the STRIVERDI RESPIMAT profile page.

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

Summary for 203108

Tradename:	STRIVERDI RESPIMAT
Applicant:	Boehringer Ingelheim
Ingredient:	olodaterol hydrochloride
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 203108

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 NDA: 203108

Mechanism of Action

Adrenergic beta2-Agonists

Suppliers and Packaging for NDA: 203108

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0192	0597-0192-61	1 CARTRIDGE in 1 CARTON (0597-0192-61) / 60 SPRAY, METERED in 1 CARTRIDGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY, METERED;INHALATION			Strength	EQ 0.0025MG BASE/INH
Approval Date:	Jul 31, 2014	TE:		RLD:	Yes
Patent:		Patent Expiration:	Jan 19, 2027	Product Flag?		Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 203108

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014

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