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Last Updated: March 28, 2024

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*:
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
Patent:⤷  Try a TrialPatent Expiration:Apr 1, 2025Product Flag?YSubstance Flag?YDelist Request?
Patent:⤷  Try a TrialPatent Expiration:Apr 29, 2031Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 211172

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

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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.