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. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the GIVLAARI profile page.

The generic ingredient in GIVLAARI is givosiran sodium. One supplier is listed for this compound. 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 Loss of Exclusivity (LOE) Date for 212194

Generic Entry Date for 212194^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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: 212194

Physiological Effect	Decreased RNA Integrity

Suppliers and Packaging for NDA: 212194

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194	NDA	Alnylam Pharmaceuticals, Inc.	71336-1001	71336-1001-1	1 VIAL, SINGLE-USE in 1 CARTON (71336-1001-1) / 1 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	EQ 189MG BASE/ML (EQ 189MG BASE/ML)
Approval Date:	Nov 20, 2019	TE:		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:	⤷ Sign Up	Patent Expiration:	Oct 3, 2034	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF ACUTE HEPATIC PORPHYRIA

Expired US Patents for NDA 212194

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019	⤷ Sign Up	⤷ Sign Up
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019	⤷ Sign Up	⤷ Sign Up
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019	⤷ Sign Up	⤷ Sign Up
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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