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Last Updated: October 11, 2024

PATISIRAN SODIUM - Generic Drug Details


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What are the generic drug sources for patisiran sodium and what is the scope of freedom to operate?

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

Patisiran sodium has two hundred and forty-seven patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for PATISIRAN SODIUM
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PATISIRAN SODIUM
Generic Entry Date for PATISIRAN SODIUM*:
Constraining patent/regulatory exclusivity:
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.

Anatomical Therapeutic Chemical (ATC) Classes for PATISIRAN SODIUM

US Patents and Regulatory Information for PATISIRAN 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 ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up 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 PATISIRAN SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 ⤷  Sign Up ⤷  Sign Up
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 ⤷  Sign Up ⤷  Sign Up
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 ⤷  Sign Up ⤷  Sign Up
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 ⤷  Sign Up ⤷  Sign Up
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 ⤷  Sign Up ⤷  Sign Up
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for PATISIRAN SODIUM

Country Patent Number Title Estimated Expiration
Norway 2019004 ⤷  Sign Up
Canada 2739895 COMPOSITIONS ET PROCEDES POUR INHIBER L'EXPRESSION DE LA TRANSTHYRETINE (COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF TRANSTHYRETIN) ⤷  Sign Up
Japan 2017036330 製剤用化合物 (COMPOUND FOR PREPARATION) ⤷  Sign Up
Japan 2015232048 改善された脂質製剤 (IMPROVED LIPID FORMULATION) ⤷  Sign Up
South Korea 20220038506 향상된 지질 조성물 (IMPROVED LIPID FORMULATION) ⤷  Sign Up
Hong Kong 1156348 抑制運甲狀腺素蛋白表達的組合物和方法 (COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF TRANSTHYRETIN) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PATISIRAN SODIUM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2937418 C201930007 Spain ⤷  Sign Up PRODUCT NAME: PATISIRAN; NATIONAL AUTHORISATION NUMBER: EU/1/18/1320; DATE OF AUTHORISATION: 20180827; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1320; DATE OF FIRST AUTHORISATION IN EEA: 20180827
2937418 2019/004 Ireland ⤷  Sign Up PRODUCT NAME: PATISIRAN; REGISTRATION NO/DATE: EU/1/18/1320 20180827
2937418 3/2019 Austria ⤷  Sign Up PRODUCT NAME: PATISIRAN; REGISTRATION NO/DATE: EU/1/18/1320 (MITTEILUNG) 20180829
2937418 1990004-2 Sweden ⤷  Sign Up PRODUCT NAME: PATISIRAN; REG. NO/DATE: EU/1/18/1320 20180829
2937418 2019C/501 Belgium ⤷  Sign Up PRODUCT NAME: PATISIRAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1320 20180829
2937418 CR 2019 00005 Denmark ⤷  Sign Up PRODUCT NAME: PATISIRAN; REG. NO/DATE: EU/1/18/1320 20180829
>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.