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Serving leading biopharmaceutical companies globally:

McKesson
AstraZeneca
Moodys
Mallinckrodt
Johnson and Johnson
Boehringer Ingelheim

Last Updated: November 28, 2021

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GIVLAARI Drug Patent Profile


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DrugPatentWatch® Generic Entry Outlook for Givlaari

Givlaari will be eligible for patent challenges on November 20, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 3, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for GIVLAARI
International Patents:393
US Patents:12
Applicants:1
NDAs:1
Clinical Trials: 1
Drug Prices: Drug price information for GIVLAARI
What excipients (inactive ingredients) are in GIVLAARI?GIVLAARI excipients list
DailyMed Link:GIVLAARI at DailyMed
Drug patent expirations by year for GIVLAARI
Drug Prices for GIVLAARI

See drug prices for GIVLAARI

DrugPatentWatch® Estimated Generic Entry Opportunity Date for GIVLAARI
Generic Entry Date for GIVLAARI*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for GIVLAARI

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Alnylam PharmaceuticalsPhase 3

See all GIVLAARI clinical trials

US Patents and Regulatory Information for GIVLAARI

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

Supplementary Protection Certificates for GIVLAARI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3052628 PA2020527 Lithuania ⤷  Free Forever Trial PRODUCT NAME: GIVOSIRANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1428 20200302
3052628 CR 2020 00042 Denmark ⤷  Free Forever Trial PRODUCT NAME: GIVOSIRAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/20/1428 20200304
3052628 122020000045 Germany ⤷  Free Forever Trial PRODUCT NAME: GIVOSIRAN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1428 20200302
3052628 2020/038 Ireland ⤷  Free Forever Trial PRODUCT NAME: GIVOSIRAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/20/1428 20200304; FIRST REGISTRATION NO/DATE: EU/1/20/1428 04/03/2020
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Moodys
McKesson
McKinsey
Merck
Johnson and Johnson

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.