Details for New Drug Application (NDA): 219132
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NDA 219132 describes AQNEURSA, which is a drug marketed by Intrabio and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the AQNEURSA profile page.
The generic ingredient in AQNEURSA is levacetylleucine. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the levacetylleucine profile page.
The generic ingredient in AQNEURSA is levacetylleucine. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the levacetylleucine profile page.
Summary for 219132
| Tradename: | AQNEURSA |
| Applicant: | Intrabio |
| Ingredient: | levacetylleucine |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219132
Generic Entry Date for 219132*:
Constraining patent/regulatory exclusivity:
TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) IN ADULTS AND PEDIATRIC PATIENTS WEIGHING GREATER THAN OR EQUAL TO 15 KG Dosage:
FOR SUSPENSION;ORAL |
*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: 219132
Suppliers and Packaging for NDA: 219132
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AQNEURSA | levacetylleucine | FOR SUSPENSION;ORAL | 219132 | NDA | IntraBio Inc | 83853-101 | 83853-101-01 | 28 PACKET in 1 CARTON (83853-101-01) / 1 GRANULE, FOR SUSPENSION in 1 PACKET |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 1GM/PACKET | ||||
| Approval Date: | Sep 24, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 24, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Sep 24, 2031 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) IN ADULTS AND PEDIATRIC PATIENTS WEIGHING GREATER THAN OR EQUAL TO 15 KG | ||||||||
| Patent: | 11,400,067 | Patent Expiration: | Apr 19, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE OF LEVACETYLLEUCINE FOR TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE-C (NPC) | ||||||||
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