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Last Updated: October 26, 2021

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Details for New Drug Application (NDA): 212194


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NDA 212194 describes GIVLAARI, which is a drug marketed by Alnylam Pharms Inc and is included in one NDA. There are twelve patents protecting this drug. Additional details are available on the GIVLAARI profile page.

The generic ingredient in GIVLAARI is givosiran sodium. Additional details are available on the givosiran sodium profile page.
Summary for 212194
Tradename:GIVLAARI
Applicant:Alnylam Pharms Inc
Ingredient:givosiran sodium
Patents:12
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 212194
Generic Entry Date for 212194*:
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.

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrengthEQ 189MG BASE/ML (EQ 189MG BASE/ML)
Approval Date:Nov 20, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 20, 2026
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF ADULTS WITH ACUTE HEPATIC PORPHYRIA (AHP)
Regulatory Exclusivity Expiration:Nov 20, 2024
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Free Forever TrialPatent Expiration:Oct 3, 2034Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ACUTE HEPATIC PORPHYRIA

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