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The generic ingredient in ONPATTRO is patisiran sodium. One supplier is listed for this compound. Additional details are available on the patisiran sodium profile page.
Generic Entry Opportunity Date for 210922
*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.
Suppliers and Packaging for NDA: 210922
Profile for product number 001
|Active Rx/OTC/Discontinued:||RX||Dosage:||SOLUTION;INTRAVENOUS||Strength||EQ 10MG BASE/5ML (EQ 2MG BASE/ML)|
|Approval Date:||Aug 10, 2018||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Aug 10, 2025|
|Regulatory Exclusivity Use:||INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS|
|Regulatory Exclusivity Expiration:||Aug 10, 2023|
|Regulatory Exclusivity Use:||NEW CHEMICAL ENTITY|
|Patent:||Start Trial||Patent Expiration:||Apr 15, 2029||Product Flag?||Y||Substance Flag?||Delist Request?|
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