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Details for New Drug Application (NDA): 205382
NDA 205382 describes INCRUSE ELLIPTA, which is a drug marketed by Glaxo Grp England and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the INCRUSE ELLIPTA profile page.
The generic ingredient in INCRUSE ELLIPTA is umeclidinium bromide. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the umeclidinium bromide profile page.
The generic ingredient in INCRUSE ELLIPTA is umeclidinium bromide. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the umeclidinium bromide profile page.
Summary for 205382
| Tradename: | INCRUSE ELLIPTA |
| Applicant: | Glaxo Grp England |
| Ingredient: | umeclidinium bromide |
| Patents: | 10 |
Generic Entry Opportunity Date for 205382
Generic Entry Date for 205382*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;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: 205382
| Mechanism of Action | Cholinergic Antagonists |
Suppliers and Packaging for NDA: 205382
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INCRUSE ELLIPTA | umeclidinium bromide | POWDER;INHALATION | 205382 | NDA | GlaxoSmithKline LLC | 0173-0873 | 0173-0873-06 | 1 TRAY in 1 CARTON (0173-0873-06) > 1 INHALER in 1 TRAY > 7 AEROSOL, POWDER in 1 INHALER |
| INCRUSE ELLIPTA | umeclidinium bromide | POWDER;INHALATION | 205382 | NDA | GlaxoSmithKline LLC | 0173-0873 | 0173-0873-10 | 1 TRAY in 1 CARTON (0173-0873-10) > 1 INHALER in 1 TRAY > 30 AEROSOL, POWDER in 1 INHALER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | EQ 62.5MCG BASE/INH | ||||
| Approval Date: | Apr 30, 2014 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 24, 2019 | ||||||||
| Regulatory Exclusivity Use: | UPDATES TO THE CLINICAL TRIALS SECTION OF THE LABELING TO INCLUDE RESULTS OF STUDIES PERFORMED TO EVALUATE THE BENEFIT OF ADDING INCRUSE ELLIPTA TO PATIENTS WHO ARE ON BACKGROUND THERAPY WITH BREO ELLIPTA AND ADVAIR DISKUS | ||||||||
| Patent: | Start Trial | Patent Expiration: | Dec 18, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | Start Trial | Patent Expiration: | Apr 27, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Expired US Patents for NDA 205382
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxo Grp England | INCRUSE ELLIPTA | umeclidinium bromide | POWDER;INHALATION | 205382-001 | Apr 30, 2014 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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