Details for New Drug Application (NDA): 217389
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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: | 3 |
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.
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 |
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: | ⤷ Subscribe | Patent Expiration: | Sep 15, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Subscribe | Patent Expiration: | Aug 21, 2031 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Patented Use: | FOR THE MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) IN ADULT PATIENTS |
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