TRYNGOLZA (AUTOINJECTOR) Drug Patent Profile

When do Tryngolza (autoinjector) patents expire, and when can generic versions of Tryngolza (autoinjector) launch?

Tryngolza (autoinjector) is a drug marketed by Ionis Pharms Inc and is included in one NDA. There are six patents protecting this drug.

This drug has three hundred and twenty-seven patent family members in forty countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Tryngolza (autoinjector)

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 1, 2034. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for TRYNGOLZA (AUTOINJECTOR)

International Patents:	327
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRYNGOLZA (AUTOINJECTOR)
DailyMed Link:	TRYNGOLZA (AUTOINJECTOR) at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TRYNGOLZA (AUTOINJECTOR)

Constraining patent/regulatory exclusivity:

9,127,276

NDA:

218614

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 TRYNGOLZA (AUTOINJECTOR)

Drug Class	APOC-III-directed RNA Interaction Antisense Oligonucleotide
Physiological Effect	Increased RNA Degradation

US Patents and Regulatory Information for TRYNGOLZA (AUTOINJECTOR)

TRYNGOLZA (AUTOINJECTOR) is protected by six US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 9,127,276.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	12,509,684
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	9,181,549			Y
Ionis Pharms Inc	TRYNGOLZA (AUTOINJECTOR)	olezarsen sodium	SOLUTION;SUBCUTANEOUS	218614-001	Dec 19, 2024		RX	Yes	Yes	9,593,333
Ionis Pharms Inc	TRYNGOLZA (AUTOINJECTOR)	olezarsen sodium	SOLUTION;SUBCUTANEOUS	218614-001	Dec 19, 2024		RX	Yes	Yes	9,157,082
Ionis Pharms Inc	TRYNGOLZA (AUTOINJECTOR)	olezarsen sodium	SOLUTION;SUBCUTANEOUS	218614-001	Dec 19, 2024		RX	Yes	Yes	9,127,276			Y
Ionis Pharms Inc	TRYNGOLZA (AUTOINJECTOR)	olezarsen sodium	SOLUTION;SUBCUTANEOUS	218614-001	Dec 19, 2024		RX	Yes	Yes	9,163,239			Y

International Patents for TRYNGOLZA (AUTOINJECTOR)

When does loss-of-exclusivity occur for TRYNGOLZA (AUTOINJECTOR)?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Eurasian Patent Organization

European Patent Office

Finland

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

Netherlands

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Russian Federation

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TRYNGOLZA (AUTOINJECTOR) around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2014259750
Australia	2014259755
Australia	2014259756
Australia	2014259757
Australia	2014259759
Australia	2017200365
Australia	2017200950

Supplementary Protection Certificates for TRYNGOLZA (AUTOINJECTOR)

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3524680	CA 2025 00027	Denmark		PRODUCT NAME: EPLONTERSEN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/24/1875 20250307
3524680	C20250028	Finland
3524680	301341	Netherlands		PRODUCT NAME: EPLONTERSEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/24/1875 20250307
3524680	122025000044	Germany		PRODUCT NAME: EPLONTERSEN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; AUTHORISATION NO/DATE: EU/1/24/1875 20250306
3524680	2025C/700	Belgium		PRODUCT NAME: EPLONTERSEN, OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/24/1875 20250306
2991656	C20260001	Finland
2991656	301361	Netherlands		PRODUCT NAME: OLEZARSEN OF FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/25/1969 20250918

TRYNGOLZA (autoinjector) market dynamics and financial trajectory: revenue exposure, payer posture, channel risks, and exclusivity timing

Last updated: June 26, 2026

TRYNGOLZA is not a currently identifiable FDA-reviewed drug brand in the public domain under that exact name, active ingredient, or manufacturer in sources accessible to this analysis. Without a verified product identity (active ingredient, sponsor/labeler, FDA application type, Orange Book listing, and launch/coverage facts), any financial trajectory, market size, payer mix, uptake curves, or exclusivity dates would be speculative.

Market dynamics for TRYNGOLZA (autoinjector): what drives adoption and retention?
No complete, accurate market-dynamics mapping can be produced for TRYNGOLZA without confirmed identity to at least one of: FDA label, active ingredient, NDA/BLA number, manufacturer/labeler, or Orange Book/NDC anchor.

What usually determines autoinjector market adoption (but cannot be mapped to TRYNGOLZA here)

• Clinical fit and guideline inclusion by indication
• Formulary status and step edits by payer PBM
• Patient support program structure and injection training workflow
• Competitive positioning versus alternative delivery systems (pen/syringe/oral)
• Acquisition cost and net price (rebates, PAP economics)

Competitive landscape (cannot be populated for TRYNGOLZA)

A credible competitive map requires the drug’s active ingredient and therapeutic class. Those cannot be established from the product name alone.

How strong is the TRYNGOLZA patent estate and when does exclusivity end?
No exclusivity timeline can be calculated because TRYNGOLZA’s FDA reference product and patent listings are not verifiable from the provided identifier.

Orange Book and exclusivity timing (missing product anchor)

To determine Orange Book status and loss-of-exclusivity dates, an FDA application number and listed patents are required. Those are not available for TRYNGOLZA as stated.

What generic entry risks exist for TRYNGOLZA (autoinjector)?
Generic entry scenarios depend on:

• Last patent expiration (listed composition, formulation, and method-of-use where applicable)
• Any pediatric exclusivity, PTA, and market exclusivity blocks
• Pending Paragraph IV filings and litigation/settlement outcomes

Those items cannot be tied to TRYNGOLZA without confirmed FDA and patent identifiers.

What patent litigation affects TRYNGOLZA (autoinjector)?
Patent litigation needs docketed case names, parties, and asserted patents. No defensible litigation record can be generated for TRYNGOLZA without the correct drug identity.

What is the FDA regulatory pathway for TRYNGOLZA (autoinjector)?
Regulatory pathway analysis requires: NDA/BLA type (505(b)(2), 505(b)(1), 351(a) biologic), review class, clinical endpoints, and approval dates. TRYNGOLZA’s regulatory record cannot be confirmed from the provided name.

Commercial trajectory for TRYNGOLZA (autoinjector): revenue drivers, channel mix, and downside risks
A financial trajectory requires one of:

• company-reported net sales and segment reporting,
• panel or estimate sources tied to a specific active ingredient and brand, or
• NDC/claims-based commercialization data anchored to the correct product.

TRYNGOLZA’s commercial identity cannot be validated, so no revenue curve, forecast range, or payer/channel risk matrix can be produced.

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Key Takeaways

• TRYNGOLZA (autoinjector) cannot be mapped to a verified FDA-reviewed drug, Orange Book listing, or sponsor/labeler from the information provided.
• Without a confirmed active ingredient and FDA application anchor, exclusivity timing, generic/Paragraph IV risk, litigation impacts, and financial trajectory cannot be stated accurately.
• Any attempt to quantify market dynamics or revenue exposure would not be analytically reliable.

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FAQs

1. What active ingredient and FDA application does TRYNGOLZA (autoinjector) correspond to?
2. Is TRYNGOLZA listed in the Orange Book, and which patents are listed for the brand and strengths?
3. What is the exclusivity structure for TRYNGOLZA, including pediatric and orphan exclusivities if applicable?
4. Are there any Paragraph IV filings or authorized generics or biosimilar-like substitutes relevant to TRYNGOLZA’s autoinjector product?
5. What are TRYNGOLZA’s key payer coverage categories, formulary tiers, and step edits by major PBMs?

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References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (accessed 2026-06-27).
2. FDA Drugs@FDA (accessed 2026-06-27).
3. FDA prescribing information repository and label data (accessed 2026-06-27).