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 nine 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: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 | Adrenergic beta2-Agonists Cholinergic Antagonists |
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 |
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 | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | May 12, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF RESPIRATORY COMPLAINTS | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Feb 26, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | Apr 10, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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 | ⤷ Subscribe | ⤷ Subscribe |
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | ⤷ Subscribe | ⤷ Subscribe |
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | ⤷ Subscribe | ⤷ Subscribe |
| Boehringer Ingelheim | STIOLTO RESPIMAT | olodaterol hydrochloride; tiotropium bromide | SPRAY, METERED;INHALATION | 206756-001 | May 21, 2015 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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