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Last Updated: December 23, 2024

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*:
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.

Pharmacology for NDA: 212194
Physiological EffectDecreased 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: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:10,119,143Patent Expiration:Oct 3, 2034Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ACUTE HEPATIC PORPHYRIA

Expired US Patents for NDA 212194

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 10,273,477 ⤷  Subscribe
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 9,708,615 ⤷  Subscribe
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 9,708,610 ⤷  Subscribe
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 11,530,408 ⤷  Subscribe
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 8,546,143 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.