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 six patents protecting this drug. Additional details are available on the TRYNGOLZA (AUTOINJECTOR) profile page.
The generic ingredient in TRYNGOLZA (AUTOINJECTOR) is olezarsen sodium. There is one drug master file entry for this compound. 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. There is one drug master file entry for this compound. 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: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218614
Generic Entry Date for 218614*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 218614
| Physiological Effect | Increased RNA Degradation |
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 |
| TRYNGOLZA (AUTOINJECTOR) | olezarsen sodium | SOLUTION;SUBCUTANEOUS | 218614 | NDA | Ionis Pharmaceuticals, Inc. | 71860-102 | 71860-102-01 | 1 SYRINGE, GLASS in 1 CARTON (71860-102-01) / .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) | ||||||||
| Regulatory Exclusivity Expiration: | Jun 24, 2029 | ||||||||
| Regulatory Exclusivity Use: | AS AN ADJUNCT TO DIET TO REDUCE TRIGLYCERIDES (TG) AND THE RISK OF ACUTE PANCREATITIS IN ADULTS WITH SEVERE HYPERTRIGLYCERIDEMIA (SHTG: TG GREATER THAN OR EQUAL TO 500 MG/DL) | ||||||||
| Patent: | 12,509,684 | Patent Expiration: | May 1, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE IN REDUCING TRIGLYCERIDES AND THE RISK OF ACUTE PANCREATITIS IN ADULTS WITH SEVERE HYPERTRIGLYCERIDEMIA (SHTG: TG GREATER THAN OR EQUAL TO 500 MG/DL) | ||||||||
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