Details for New Drug Application (NDA): 203975
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NDA 203975 describes ANORO ELLIPTA, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from two suppliers. There are nine patents protecting this drug. Additional details are available on the ANORO ELLIPTA profile page.
The generic ingredient in ANORO ELLIPTA is umeclidinium bromide; vilanterol trifenatate. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the umeclidinium bromide; vilanterol trifenatate profile page.
The generic ingredient in ANORO ELLIPTA is umeclidinium bromide; vilanterol trifenatate. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the umeclidinium bromide; vilanterol trifenatate profile page.
Summary for 203975
| Tradename: | ANORO ELLIPTA |
| Applicant: | Glaxosmithkline |
| Ingredient: | umeclidinium bromide; vilanterol trifenatate |
| Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203975
Generic Entry Date for 203975*:
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: 203975
| Mechanism of Action | Adrenergic beta2-Agonists Cholinergic Antagonists |
Suppliers and Packaging for NDA: 203975
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ANORO ELLIPTA | umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 203975 | NDA | GlaxoSmithKline LLC | 0173-0869 | 0173-0869-06 | 1 TRAY in 1 CARTON (0173-0869-06) / 1 INHALER in 1 TRAY / 7 POWDER in 1 INHALER |
| ANORO ELLIPTA | umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 203975 | NDA | GlaxoSmithKline LLC | 0173-0869 | 0173-0869-10 | 1 TRAY in 1 CARTON (0173-0869-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | ||||
| Approval Date: | Dec 18, 2013 | TE: | RLD: | Yes | |||||
| Patent: | 11,090,294 | Patent Expiration: | Nov 29, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) | ||||||||
| Patent: | 12,396,986 | Patent Expiration: | Nov 29, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 7,439,393*PED | Patent Expiration: | Nov 21, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 203975
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline | ANORO ELLIPTA | umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 203975-001 | Dec 18, 2013 | RE44874 | ⤷ Get Started Free |
| Glaxosmithkline | ANORO ELLIPTA | umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 203975-001 | Dec 18, 2013 | 5,873,360 | ⤷ Get Started Free |
| Glaxosmithkline | ANORO ELLIPTA | umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 203975-001 | Dec 18, 2013 | 8,309,572 | ⤷ Get Started Free |
| Glaxosmithkline | ANORO ELLIPTA | umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 203975-001 | Dec 18, 2013 | 7,776,895 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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