Details for New Drug Application (NDA): 210598
✉ Email this page to a colleague
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 Action | Cholinergic 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: | RX | Dosage: | SOLUTION;INHALATION | Strength | 175MCG/3ML | ||||
Approval Date: | Nov 9, 2018 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 10, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 10, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jul 14, 2030 | Product Flag? | Substance Flag? | Y | Delist Request? |
Complete Access Available with Subscription