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Serving leading biopharmaceutical companies globally:

Teva
Merck
Mallinckrodt
Queensland Health
Healthtrust
Daiichi Sankyo
Boehringer Ingelheim
Moodys
Express Scripts
Deloitte

Generated: October 21, 2017

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 twenty-five 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 NDA: 206756

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:25

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 0597-0155-61 1 CARTRIDGE in 1 CARTON (0597-0155-61) > 60 SPRAY, METERED in 1 CARTRIDGE

Summary 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 Orange Book 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;INHALATION206756-001May 21, 2015► Subscribe► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 2015► Subscribe► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 2015► Subscribe► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 2015► Subscribe► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 2015► Subscribe► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 2015► Subscribe► Subscribe
Boehringer Ingelheim
STIOLTO RESPIMAT
olodaterol hydrochloride; tiotropium bromide
SPRAY, METERED;INHALATION206756-001May 21, 2015► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

UBS
Daiichi Sankyo
McKinsey
Dow
Merck
Baxter
QuintilesIMS
Citi
Cantor Fitzgerald
Argus Health

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