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Last Updated: February 9, 2023

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 six 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:6
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 211172
Generic Entry Date for 211172*:
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 NDA: 211172
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:RXDosage:SOLUTION;SUBCUTANEOUSStrengthEQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML)
Approval Date:Oct 5, 2018TE: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
Regulatory Exclusivity Expiration:Oct 5, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:See Plans and PricingPatent Expiration:Mar 21, 2023Product Flag?Substance Flag?YDelist Request?

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