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Last Updated: July 23, 2024

Givosiran sodium - Generic Drug Details


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What are the generic drug sources for givosiran sodium and what is the scope of patent protection?

Givosiran sodium is the generic ingredient in one branded drug marketed by Alnylam Pharms Inc and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Givosiran sodium has three hundred and twenty-four patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for givosiran sodium
International Patents:324
US Patents:12
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
What excipients (inactive ingredients) are in givosiran sodium?givosiran sodium excipients list
DailyMed Link:givosiran sodium at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for givosiran sodium
Generic Entry Date for givosiran sodium*:
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 givosiran sodium

US Patents and Regulatory Information for givosiran sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for givosiran sodium

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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for givosiran sodium

Country Patent Number Title Estimated Expiration
European Patent Office 3868883 COMPOSITIONS ET PROCÉDÉS D'INHIBITION D'EXPRESSION DU GÈNE ALAS1 (COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE) ⤷  Sign Up
Australia 2012202250 Modified iRNA agents ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2004044131 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for givosiran sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3052628 PA2020527 Lithuania ⤷  Sign Up PRODUCT NAME: GIVOSIRANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1428 20200302
3052628 132020000000106 Italy ⤷  Sign Up PRODUCT NAME: GIVOSIRAN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(GIVLAARI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1428, 20200304
3052628 CA 2020 00042 Denmark ⤷  Sign Up PRODUCT NAME: GIVOSIRAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/20/1428 20200304
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.