Details for New Drug Application (NDA): 218614
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NDA 218614 describes TRYNGOLZA (AUTOINJECTOR), which is a drug marketed by Ionis Pharms Inc 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 TRYNGOLZA (AUTOINJECTOR) profile page.
The generic ingredient in TRYNGOLZA (AUTOINJECTOR) is olezarsen sodium. One supplier is listed for this compound. Additional details are available on the olezarsen sodium profile page.
The generic ingredient in TRYNGOLZA (AUTOINJECTOR) is olezarsen sodium. One supplier is listed for this compound. Additional details are available on the olezarsen sodium profile page.
Summary for 218614
| Tradename: | TRYNGOLZA (AUTOINJECTOR) |
| Applicant: | Ionis Pharms Inc |
| Ingredient: | olezarsen sodium |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218614
Generic Entry Date for 218614*:
Constraining patent/regulatory exclusivity:
ADJUNCT TO DIET TO REDUCE TRIGLYCERIDES IN ADULTS WITH FAMILIAL CHYLOMICRONEMIA SYNDROME (FCS) Dosage:
SOLUTION;SUBCUTANEOUS |
*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: 218614
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRYNGOLZA (AUTOINJECTOR) | olezarsen sodium | SOLUTION;SUBCUTANEOUS | 218614 | NDA | Ionis Pharmaceuticals, Inc. | 71860-101 | 71860-101-01 | 1 SYRINGE, GLASS in 1 CARTON (71860-101-01) / .8 mL in 1 SYRINGE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) | ||||
| Approval Date: | Dec 19, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 19, 2031 | ||||||||
| Regulatory Exclusivity Use: | ADJUNCT TO DIET TO REDUCE TRIGLYCERIDES IN ADULTS WITH FAMILIAL CHYLOMICRONEMIA SYNDROME (FCS) | ||||||||
| Patent: | 9,127,276 | Patent Expiration: | May 1, 2034 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | 9,157,082 | Patent Expiration: | Apr 27, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE IN REDUCING TRIGLYCERIDES IN ADULTS WITH FAMILIAL CHYLOMICRONEMIA SYNDROME (FCS) | ||||||||
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