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The generic ingredient in TEGSEDI is inotersen sodium. Additional details are available on the inotersen sodium profile page.
Generic Entry Opportunity Date for 211172
*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:||RX||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|
|Regulatory Exclusivity Expiration:||Oct 5, 2023|
|Regulatory Exclusivity Use:||NEW CHEMICAL ENTITY|
|Patent:||Start Trial||Patent Expiration:||Mar 21, 2023||Product Flag?||Substance Flag?||Y||Delist Request?|
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