Details for New Drug Application (NDA): 022383
✉ Email this page to a colleague
The generic ingredient in ARCAPTA NEOHALER is indacaterol maleate. Additional details are available on the indacaterol maleate profile page.
Summary for 022383
Tradename: | ARCAPTA NEOHALER |
Applicant: | Novartis |
Ingredient: | indacaterol maleate |
Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022383
Generic Entry Date for 022383*:
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.
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INHALATION | Strength | EQ 75MCG BASE | ||||
Approval Date: | Jul 1, 2011 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Feb 25, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | THE LONG TERM, ONCE-DAILY MAINTENANCE BRONCHODILATOR TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 11, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 022383
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | ARCAPTA NEOHALER | indacaterol maleate | POWDER;INHALATION | 022383-001 | Jul 1, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | ARCAPTA NEOHALER | indacaterol maleate | POWDER;INHALATION | 022383-001 | Jul 1, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | ARCAPTA NEOHALER | indacaterol maleate | POWDER;INHALATION | 022383-001 | Jul 1, 2011 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription