Olezarsen sodium - Generic Drug Details

What are the generic drug sources for olezarsen sodium and what is the scope of freedom to operate?

Olezarsen sodium is the generic ingredient in one branded drug marketed by Ionis Pharms Inc and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Olezarsen sodium has three hundred and two patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for olezarsen sodium

International Patents:	302
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in olezarsen sodium?	olezarsen sodium excipients list
DailyMed Link:	olezarsen sodium at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for olezarsen sodium

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.

US Patents and Regulatory Information for olezarsen sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ionis Pharms Inc	TRYNGOLZA (AUTOINJECTOR)	olezarsen sodium	SOLUTION;SUBCUTANEOUS	218614-001	Dec 19, 2024		RX	Yes	Yes				Y
Ionis Pharms Inc	TRYNGOLZA (AUTOINJECTOR)	olezarsen sodium	SOLUTION;SUBCUTANEOUS	218614-001	Dec 19, 2024		RX	Yes	Yes
Ionis Pharms Inc	TRYNGOLZA (AUTOINJECTOR)	olezarsen sodium	SOLUTION;SUBCUTANEOUS	218614-001	Dec 19, 2024		RX	Yes	Yes				Y
Ionis Pharms Inc	TRYNGOLZA (AUTOINJECTOR)	olezarsen sodium	SOLUTION;SUBCUTANEOUS	218614-001	Dec 19, 2024		RX	Yes	Yes
Ionis Pharms Inc	TRYNGOLZA (AUTOINJECTOR)	olezarsen sodium	SOLUTION;SUBCUTANEOUS	218614-001	Dec 19, 2024		RX	Yes	Yes				Y

International Patents for olezarsen sodium

Country	Patent Number	Title	Estimated Expiration
Croatia	P20190987
Hong Kong	1221486	組合物和方法 (COMPOSITIONS AND METHODS)
Hungary	E050394
Russian Federation	2015151204	КОМПОЗИЦИИ И СПОСОБЫ
Russian Federation	2670614	КОМПОЗИЦИИ И СПОСОБЫ МОДУЛИРОВАНИЯ ЭКСПРЕССИИ HBV И TTR (COMPOSITIONS AND METHODS FOR MODULATING HBV AND TTR EXPRESSION)
Russian Federation	2018136140	КОМПОЗИЦИИ И СПОСОБЫ МОДУЛИРОВАНИЯ ЭКСПРЕССИИ HBV И TTR

Olezarsen sodium Market Analysis and Financial Projection

Here are the key market dynamics and financial trajectory details for olezarsen sodium (brand name Tryngolza):

Regulatory Milestones:

• In December 2024, the FDA approved olezarsen (Tryngolza) as the first treatment for familial chylomicronemia syndrome (FCS) in the U.S.[9][11]

• The FDA granted olezarsen Fast Track designation for FCS in January 2023, as well as Orphan Drug designation and Breakthrough Therapy designation in February 2024.[9]

• Regulatory filings for FCS are planned in the European Union in 2024.[9]

Market Potential:

• Olezarsen is being developed for two indications:

  1. Familial chylomicronemia syndrome (FCS) - a rare genetic disorder
  2. Severe hypertriglyceridemia (sHTG) - a much broader indication[6]

• The revenue for olezarsen is expected to reach an annual total of $112 million by 2034 in the U.S. based on GlobalData's forecasts.[1]

Clinical Development:

• Positive Phase 3 results were reported in September 2023 for FCS, showing statistically significant triglyceride lowering and reduction in acute pancreatitis events.[6]

• Three Phase 3 trials (CORE, CORE2, ESSENCE) evaluating olezarsen for sHTG completed enrollment in H1 2024, with over 2,400 patients total. Data is expected in H2 2025.[9]

Financial Trajectory:

• Ionis Pharmaceuticals, the developer of olezarsen, reported revenues of $788 million in 2023, up 34.1% from 2022.[6]

• The company ended 2023 with $2.3 billion in cash and short-term investments.[6]

• Ionis is investing in commercial readiness for olezarsen and other late-stage programs.[6]

Market Positioning:

• Olezarsen would be the first approved treatment for FCS in the U.S.[9]

• For sHTG, it would enter a larger market with more competition but significant unmet need.

In summary, olezarsen has near-term revenue potential in the rare disease FCS market, with longer-term upside if approved for the broader sHTG indication. Its regulatory and clinical progress indicate a positive trajectory, though full commercial potential remains to be seen as it enters the market.