Olezarsen sodium - Generic Drug Details
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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 six patents protecting this compound. Additional information is available in the individual branded drug profile pages.One supplier is listed for this compound.
Summary for olezarsen sodium
| International Patents: | 327 |
| US Patents: | 6 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for olezarsen sodium |
| 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
Generic Entry Date for olezarsen sodium*:
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 olezarsen sodium
| Drug Class | APOC-III-directed RNA Interaction Antisense Oligonucleotide |
| Physiological Effect | Increased RNA Degradation |
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 | 9,593,333 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Ionis Pharms Inc | TRYNGOLZA (AUTOINJECTOR) | olezarsen sodium | SOLUTION;SUBCUTANEOUS | 218614-001 | Dec 19, 2024 | RX | Yes | Yes | 9,127,276 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Ionis Pharms Inc | TRYNGOLZA (AUTOINJECTOR) | olezarsen sodium | SOLUTION;SUBCUTANEOUS | 218614-002 | Jun 24, 2026 | RX | Yes | Yes | 12,509,684 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Ionis Pharms Inc | TRYNGOLZA (AUTOINJECTOR) | olezarsen sodium | SOLUTION;SUBCUTANEOUS | 218614-002 | Jun 24, 2026 | RX | Yes | Yes | 9,127,276 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Ionis Pharms Inc | TRYNGOLZA (AUTOINJECTOR) | olezarsen sodium | SOLUTION;SUBCUTANEOUS | 218614-001 | Dec 19, 2024 | RX | Yes | Yes | 9,181,549 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for olezarsen sodium
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2014259750 | ⤷ Start Trial | |
| Australia | 2014259755 | ⤷ Start Trial | |
| Australia | 2014259756 | ⤷ Start Trial | |
| Australia | 2014259757 | ⤷ Start Trial | |
| Australia | 2014259759 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for olezarsen sodium
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2991656 | 2026C/701 | Belgium | ⤷ Start Trial | PRODUCT NAME: OLEZARSEN ET DES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/25/1969 20250918 |
| 3524680 | 28/2025 | Austria | ⤷ Start Trial | PRODUCT NAME: EPLONTERSEN, OPTIONAL IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON; REGISTRATION NO/DATE: EU/1/24/1875 (MITTEILUNG) 20250307 |
| 3524680 | C20250028 | Finland | ⤷ Start Trial | |
| 3524680 | 122025000044 | Germany | ⤷ Start Trial | PRODUCT NAME: EPLONTERSEN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; AUTHORISATION NO/DATE: EU/1/24/1875 20250306 |
| 3524680 | 25C1033 | France | ⤷ Start Trial | PRODUCT NAME: EPLONTERSEN, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/24/1875 20250307 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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