Details for New Drug Application (NDA): 217933
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NDA 217933 describes AURLUMYN, which is a drug marketed by Eicos Sci and is included in one NDA. It is available from one supplier. Additional details are available on the AURLUMYN profile page.
The generic ingredient in AURLUMYN is iloprost. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the iloprost profile page.
The generic ingredient in AURLUMYN is iloprost. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the iloprost profile page.
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217933
Generic Entry Date for 217933*:
Constraining patent/regulatory exclusivity:
TREATMENT OF SEVERE FROSTBITE IN ADULTS TO REDUCE THE RISK OF DIGIT AMPUTATIONS Dosage:
SOLUTION;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: 217933
Medical Subject Heading (MeSH) Categories for 217933
Suppliers and Packaging for NDA: 217933
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AURLUMYN | iloprost | SOLUTION;INTRAVENOUS | 217933 | NDA | Eicos Sciences Inc. | 83226-2001 | 83226-2001-1 | 1 VIAL, SINGLE-DOSE in 1 CARTON (83226-2001-1) / 1 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MCG/ML (100MCG/ML) | ||||
| Approval Date: | Feb 13, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 13, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Regulatory Exclusivity Expiration: | Feb 13, 2031 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF SEVERE FROSTBITE IN ADULTS TO REDUCE THE RISK OF DIGIT AMPUTATIONS | ||||||||
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