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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Farmers Insurance
Medtronic
Colorcon
AstraZeneca
US Army
Federal Trade Commission
Fish and Richardson
Moodys

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
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 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:RXDosage:SPRAY, METERED;INHALATIONStrengthEQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH
Approval Date:May 21, 2015TE: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

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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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
AstraZeneca
Chubb
Boehringer Ingelheim
Colorcon
Covington
Cerilliant
Daiichi Sankyo
Julphar

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