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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.
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: | 15 |
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
| 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 | 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: | 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: | 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 Trial | Patent Expiration: | Aug 23, 2020 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | Start Trial | Patent Expiration: | Dec 7, 2023 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Expired US Patents for NDA 206756
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