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Last Updated: October 22, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210598

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NDA 210598 describes YUPELRI, which is a drug marketed by Mylan Ireland Ltd and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the YUPELRI profile page.

The generic ingredient in YUPELRI is revefenacin. One supplier is listed for this compound. Additional details are available on the revefenacin profile page.
Summary for 210598
Tradename:YUPELRI
Applicant:Mylan Ireland Ltd
Ingredient:revefenacin
Patents:13
Generic Entry Opportunity Date for 210598
Generic Entry Date for 210598*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;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.

Suppliers and Packaging for NDA: 210598
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
YUPELRI revefenacin SOLUTION;INHALATION 210598 NDA Mylan Specialty L.P. 49502-806 49502-806-77 7 POUCH in 1 CARTON (49502-806-77) > 1 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE
YUPELRI revefenacin SOLUTION;INHALATION 210598 NDA Mylan Specialty L.P. 49502-806 49502-806-87 7 POUCH in 1 CARTON (49502-806-87) > 1 VIAL, SINGLE-DOSE in 1 POUCH (49502-806-33) > 3 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrength175MCG/3ML
Approval Date:Nov 9, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 9, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Mar 10, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Patent:  Start TrialPatent Expiration:Mar 10, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

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