Details for New Drug Application (NDA): 217389
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NDA 217389 describes OHTUVAYRE, which is a drug marketed by Verona Pharma and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the OHTUVAYRE profile page.
The generic ingredient in OHTUVAYRE is ensifentrine. One supplier is listed for this compound. Additional details are available on the ensifentrine profile page.
The generic ingredient in OHTUVAYRE is ensifentrine. One supplier is listed for this compound. Additional details are available on the ensifentrine profile page.
Summary for 217389
| Tradename: | OHTUVAYRE |
| Applicant: | Verona Pharma |
| Ingredient: | ensifentrine |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217389
Generic Entry Date for 217389*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
SUSPENSION;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: 217389
| Mechanism of Action | Phosphodiesterase 3 Inhibitors Phosphodiesterase 4 Inhibitors |
Suppliers and Packaging for NDA: 217389
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OHTUVAYRE | ensifentrine | SUSPENSION;INHALATION | 217389 | NDA | Verona Pharma, Inc. | 83034-003 | 83034-003-60 | 60 POUCH in 1 CARTON (83034-003-60) / 1 AMPULE in 1 POUCH (83034-003-01) / 2.5 mL in 1 AMPULE |
| OHTUVAYRE | ensifentrine | SUSPENSION;INHALATION | 217389 | NDA | Verona Pharma, Inc. | 83034-003 | 83034-003-65 | 60 POUCH in 1 CARTON (83034-003-65) / 5 AMPULE in 1 POUCH (83034-003-05) / 2.5 mL in 1 AMPULE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;INHALATION | Strength | 3MG/2.5ML | ||||
| Approval Date: | Jun 26, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 26, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,945,950 | Patent Expiration: | Sep 15, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 12,251,384 | Patent Expiration: | Jun 25, 2044 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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