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Generated: November 15, 2018

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Details for New Drug Application (NDA): 210922

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NDA 210922 describes ONPATTRO, which is a drug marketed by Alnylam Pharms Inc and is included in one NDA. It is available from one supplier. There are twenty-one patents protecting this drug. Additional details are available on the ONPATTRO profile page.

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.
Summary for 210922
Tradename:ONPATTRO
Applicant:Alnylam Pharms Inc
Ingredient:patisiran sodium
Patents:21
Generic Entry Opportunity Date for 210922
Generic Entry Date for 210922*:
Constraining patent/regulatory exclusivity:
INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
Dosage:
SOLUTION;INTRAVENOUS

*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
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922 NDA Alnylam Pharmaceuticals, Inc. 71336-1000 71336-1000-1 1 VIAL, SINGLE-DOSE in 1 CARTON (71336-1000-1) > 5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 10MG BASE/5ML (EQ 2MG BASE/ML)
Approval Date:Aug 10, 2018TE: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:➤ Try a Free TrialPatent Expiration:Apr 15, 2029Product Flag?YSubstance Flag?Delist Request?

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