Details for New Drug Application (NDA): 211172

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NDA 211172 describes TEGSEDI, which is a drug marketed by Akcea Theraps and is included in one NDA. There are three patents protecting this drug. Additional details are available on the TEGSEDI profile page.

The generic ingredient in TEGSEDI is inotersen sodium. Additional details are available on the inotersen sodium profile page.

Summary for 211172

Tradename:	TEGSEDI
Applicant:	Akcea Theraps
Ingredient:	inotersen sodium
Patents:	3

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 211172

Generic Entry Date for 211172^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: ⤷ Start 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.

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)
Approval Date:	Oct 5, 2018	TE:		RLD:	Yes
Patent:	⤷ Start Trial	Patent Expiration:	Apr 29, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Start Trial	Patent Expiration:	Apr 29, 2031	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:	⤷ Start Trial	Patent Expiration:	Apr 29, 2031	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN AMYLOIDOSIS

Expired US Patents for NDA 211172

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

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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. 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.

Summary for 211172

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211172

Profile for product number 001

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DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 211172