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Last Updated: April 18, 2024

Inotersen sodium - Generic Drug Details

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

Inotersen sodium is the generic ingredient in one branded drug marketed by Akcea Theraps and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Inotersen sodium has thirty-three patent family members in twenty-four countries.

One supplier is listed for this compound.

Summary for inotersen sodium

International Patents:	33
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
DailyMed Link:	inotersen sodium at DailyMed

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

Generic Entry Date for inotersen sodium^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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 inotersen sodium

Drug Class	Antisense Oligonucleotide Transthyretin-directed RNA Interaction
Physiological Effect	Decreased RNA Integrity Increased Protein Breakdown

US Patents and Regulatory Information for inotersen sodium

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for inotersen sodium

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018	⤷ Try a Trial	⤷ Try a Trial
Akcea Theraps	TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172-001	Oct 5, 2018	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for inotersen sodium

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Country	Patent Number	Title	Estimated Expiration
Cyprus	1119070		⤷ Try a Trial
Russian Federation	2592669	МОДУЛЯЦИЯ ЭКСПРЕССИИ ТРАНСТИРЕТИНА (MODULATION OF EXPRESSION OF TRANSTHYRETIN)	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2011139917		⤷ Try a Trial
Lithuania	PA2019001		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for inotersen sodium

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2563920	132019000000004	Italy	⤷ Try a Trial	PRODUCT NAME: INOTERSEN(TEGSEDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1296, 20180710
2563920	300963	Netherlands	⤷ Try a Trial	PRODUCT NAME: INOTERSEN OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/18/1296 20180710
2563920	C20190002 00303	Estonia	⤷ Try a Trial	PRODUCT NAME: INOTERSEEN;REG NO/DATE: EU/1/18/1296 10.07.2018
2563920	1/2019	Austria	⤷ Try a Trial	PRODUCT NAME: INOTERSEN; REGISTRATION NO/DATE: EU/1/18/1296 (MITTEILUNG) 20180710
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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. 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.

Summary for inotersen sodium

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

Pharmacology for inotersen sodium

Make Better Decisions: Try a trial or see plans & pricing

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