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Last Updated: April 10, 2020

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 fifteen 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
Generic Entry Opportunity Date for 206756
Generic Entry Date for 206756*:
Constraining patent/regulatory exclusivity:
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: 206756
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 0597-0155-28 1 CARTRIDGE in 1 CARTON (0597-0155-28) > 28 SPRAY, METERED in 1 CARTRIDGE
STIOLTO RESPIMAT olodaterol hydrochloride; tiotropium bromide SPRAY, METERED;INHALATION 206756 NDA Boehringer Ingelheim Pharmaceuticals Inc. 0597-0155 0597-0155-31 1 CARTRIDGE in 1 CARTON (0597-0155-31) > 28 SPRAY, METERED in 1 CARTRIDGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;INHALATIONStrengthEQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH
Approval Date:May 21, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 5, 2021
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING TO DESCRIBE FIXED-DOSE COMBINATION OF TIOTROPIUM BROMIDE AND OLODATEROL TO INCLUDE REDUCTION OF COPD EXACERBATIONS
Patent:  Start TrialPatent Expiration:Aug 23, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Dec 7, 2023Product Flag?YSubstance Flag?YDelist Request?

Expired US Patents for NDA 206756

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