Details for New Drug Application (NDA): 210598
✉ Email this page to a colleague
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 ten patents protecting this drug. Additional details are available on the YUPELRI profile page.
The generic ingredient in YUPELRI is revefenacin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the revefenacin profile page.
The generic ingredient in YUPELRI is revefenacin. There is one drug master file entry for this compound. 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: | 10 |
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 | Viatris Specialty LLC | 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 | Viatris Specialty LLC | 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: | ⤷ Start Trial | Patent Expiration: | Jul 14, 2030 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jul 14, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Oct 23, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) | ||||||||
Expired US Patents for NDA 210598
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mylan Ireland Ltd | YUPELRI | revefenacin | SOLUTION;INHALATION | 210598-001 | Nov 9, 2018 | ⤷ Start Trial | ⤷ Start Trial |
| Mylan Ireland Ltd | YUPELRI | revefenacin | SOLUTION;INHALATION | 210598-001 | Nov 9, 2018 | ⤷ Start Trial | ⤷ Start Trial |
| Mylan Ireland Ltd | YUPELRI | revefenacin | SOLUTION;INHALATION | 210598-001 | Nov 9, 2018 | ⤷ Start Trial | ⤷ Start Trial |
| Mylan Ireland Ltd | YUPELRI | revefenacin | SOLUTION;INHALATION | 210598-001 | Nov 9, 2018 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription
