Details for New Drug Application (NDA): 207930
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The generic ingredient in UTIBRON is glycopyrrolate; indacaterol maleate. There are seventeen drug master file entries for this compound. Additional details are available on the glycopyrrolate; indacaterol maleate profile page.
Summary for 207930
Tradename: | UTIBRON |
Applicant: | Novartis |
Ingredient: | glycopyrrolate; indacaterol maleate |
Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 207930
Generic Entry Date for 207930*:
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 | 15.6MCG/INH;27.5MCG/INH | ||||
Approval Date: | Oct 29, 2015 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Feb 25, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | LONG-TERM MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 20, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 11, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 207930
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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