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.
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: | 10,106,503 | 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: | 10,343,995 | 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: | 10,550,081 | Patent Expiration: | Jul 14, 2030 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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