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Last Updated: November 22, 2024

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 twenty 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:20
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.

Pharmacology for NDA: 210598
Mechanism of ActionCholinergic Antagonists
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 49502-806-87 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
YUPELRI revefenacin SOLUTION;INHALATION 210598 NDA Mylan Specialty L.P. 49502-806 49502-806-93 30 POUCH in 1 CARTON (49502-806-93) / 1 VIAL, SINGLE-DOSE in 1 POUCH (49502-806-32) / 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
Patent:⤷  Sign UpPatent Expiration:Mar 10, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Patent:⤷  Sign UpPatent Expiration:Mar 10, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Patent:⤷  Sign UpPatent Expiration:Jul 14, 2030Product Flag?Substance Flag?YDelist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.