Details for New Drug Application (NDA): 207930
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NDA 207930 describes UTIBRON, which is a drug marketed by Novartis and is included in one NDA. There are three patents protecting this drug. Additional details are available on the UTIBRON profile page.
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.
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: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | Patent Expiration: | Oct 20, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | UTIBRON | glycopyrrolate; indacaterol maleate | POWDER;INHALATION | 207930-001 | Oct 29, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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