Details for New Drug Application (NDA): 205382
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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 |
DrugPatentWatch® Estimated 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: | Jun 9, 2022 | ||||||||
Regulatory Exclusivity Use: | ADDITIONAL INFORMATION ADDED TO THE LABELING BASED ON SAFETY AND EFFICACY DATA FROM THE IMPACT TRIAL | ||||||||
Patent: | See Plans and Pricing | Patent Expiration: | Dec 18, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | See Plans and Pricing | 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 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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