Details for New Drug Application (NDA): 217202
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NDA 217202 describes RAPIBLYK, which is a drug marketed by Aop Hlth Us and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the RAPIBLYK profile page.
The generic ingredient in RAPIBLYK is landiolol hydrochloride. Two suppliers are listed for this compound. Additional details are available on the landiolol hydrochloride profile page.
The generic ingredient in RAPIBLYK is landiolol hydrochloride. Two suppliers are listed for this compound. Additional details are available on the landiolol hydrochloride profile page.
Summary for 217202
| Tradename: | RAPIBLYK |
| Applicant: | Aop Hlth Us |
| Ingredient: | landiolol hydrochloride |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217202
Generic Entry Date for 217202*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
POWDER;INTRAVENOUS |
*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: 217202
| Mechanism of Action | Adrenergic beta1-Antagonists |
Suppliers and Packaging for NDA: 217202
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RAPIBLYK | landiolol hydrochloride | POWDER;INTRAVENOUS | 217202 | NDA | AOP Orphan Pharmaceuticals GmbH | 84381-110 | 84381-110-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (84381-110-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| RAPIBLYK | landiolol hydrochloride | POWDER;INTRAVENOUS | 217202 | NDA | AOP Health US, LLC | 87073-110 | 87073-110-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (87073-110-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 280MG BASE/VIAL | ||||
| Approval Date: | Nov 22, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 22, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Apr 25, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD OF REDUCING THE HEART RATE OF A SUBJECT SUFFERING FROM SUPRAVENTRICULAR TACHYCARDIA, WHEREIN LANDIOLOL IS ADMINISTERED PARENTERALLY AT A CONSTANT DOSE OF MORE THAN 20 MCG/KG/MIN FOR 2-20 HOURS, WHEREIN THE DOSE IS NOT HIGHER THAN 40 MCG/KG/MIN | ||||||||
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