Details for New Drug Application (NDA): 217389
NDA 217389 describes OHTUVAYRE, which is a drug marketed by MSD 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. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ensifentrine profile page.
The generic ingredient in OHTUVAYRE is ensifentrine. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ensifentrine profile page.
Summary for 217389
| Tradename: | OHTUVAYRE |
| Applicant: | Msd |
| Ingredient: | ensifentrine |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217389
Generic Entry Date for 217389*:
Constraining patent/regulatory exclusivity:
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 | MERCK SHARP & DOHME LLC | 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 | MERCK SHARP & DOHME LLC | 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: | ⤷ Start Trial | Patent Expiration: | Sep 15, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 25, 2044 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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