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. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the TEGSEDI profile page.

The generic ingredient in TEGSEDI is inotersen sodium. One supplier is listed for this compound. Additional details are available on the inotersen sodium profile page.

Summary for 211172

Tradename:	TEGSEDI
Applicant:	Akcea Theraps
Ingredient:	inotersen sodium
Patents:	4

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

Generic Entry Date for 211172^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 NDA: 211172

Physiological Effect	Decreased RNA Integrity Increased Protein Breakdown

Suppliers and Packaging for NDA: 211172

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TEGSEDI	inotersen sodium	SOLUTION;SUBCUTANEOUS	211172	NDA	Akcea Therapeutics, Inc.	72126-007	72126-007-01	4 TRAY in 1 CARTON (72126-007-01) / 1 SYRINGE in 1 TRAY (72126-007-02) / 1.5 mL in 1 SYRINGE

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
Regulatory Exclusivity Expiration:	Oct 5, 2025
Regulatory Exclusivity Use:	INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
Patent:	⤷ Sign Up	Patent Expiration:	Apr 1, 2025	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Apr 29, 2031	Product Flag?	Y	Substance Flag?		Delist Request?

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

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