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Last Updated: November 20, 2019

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ONPATTRO Drug Profile

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When do Onpattro patents expire, and when can generic versions of Onpattro launch?

Onpattro is a drug marketed by Alnylam Pharms Inc and is included in one NDA. There are twenty-one patents protecting this drug.

This drug has four hundred and fifteen patent family members in thirty-two countries.

The generic ingredient in ONPATTRO is patisiran sodium. One supplier is listed for this compound. Additional details are available on the patisiran sodium profile page.

Drug patent expirations by year for ONPATTRO
Drug Prices for ONPATTRO

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Generic Entry Opportunity Date for ONPATTRO
Generic Entry Date for ONPATTRO*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Litigation for ONPATTRO

Identify potential future generic entrants

PTAB Litigation
PetitionerDate
Moderna Therapeutics, Inc.2019-01-09
Moderna Therapeutics, Inc.2018-03-05

See all ONPATTRO litigation

US Patents and Regulatory Information for ONPATTRO

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   Start Trial   Start Trial Y Y   Start Trial
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 RX Yes Yes   Start Trial   Start Trial   Start 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 ONPATTRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2937418 3/2019 Austria   Start Trial PRODUCT NAME: PATISIRAN; REGISTRATION NO/DATE: EU/1/18/1320 (MITTEILUNG) 20180829
2937418 PA2019501 Lithuania   Start Trial PRODUCT NAME: PATISIRANAS; REGISTRATION NO/DATE: EU/1/18/1320 20180827
2937418 1990004-2 Sweden   Start Trial PRODUCT NAME: PATISIRAN; REG. NO/DATE: EU/1/18/1320 20180829
2937418 LUC00098 Luxembourg   Start Trial PRODUCT NAME: PATISIRAN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (ONPATTRO ); AUTHORISATION NUMBER AND DATE: EU/1/18/1320 20180829
2937418 300965 Netherlands   Start Trial PRODUCT NAME: -; REGISTRATION NO/DATE: EU/1/18/1320 20180829
2937418 CA 2019 00005 Denmark   Start Trial PRODUCT NAME: PATISIRAN... (NAVN FOR LANGT); REG. NO/DATE: EU/1/18/1320 20180829
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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