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Last Updated: June 2, 2020

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ONPATTRO Drug Profile


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Which patents cover Onpattro, 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 thirty-eight patent family members in thirty-three countries.

The generic ingredient in ONPATTRO is patisiran sodium. Additional details are available on the patisiran sodium profile page.

US ANDA Litigation and Generic Entry Outlook for Onpattro

Onpattro will be eligible for patent challenges on August 10, 2022. 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 November 10, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ONPATTRO
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
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   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   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   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
>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 CR 2019 00005 Denmark   Start Trial PRODUCT NAME: PATISIRAN; REG. NO/DATE: EU/1/18/1320 20180829
2937418 19C1002 France   Start Trial PRODUCT NAME: PATISIRAN; REGISTRATION NO/DATE: EU/1/18/1320 20180829
2937418 2019C/501 Belgium   Start Trial PRODUCT NAME: PATISIRAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1320 20180829
1407044 132019000000031 Italy   Start Trial PRODUCT NAME: PATISIRAN(ONPATTRO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1320, 20180829
2937418 1990004-2 Sweden   Start Trial PRODUCT NAME: PATISIRAN; REG. 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
2937418 122018000133 Germany   Start Trial PRODUCT NAME: PATISIRAN; REGISTRATION NO/DATE: EU/1/18/1320 20180827
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
McKesson
Harvard Business School
Johnson and Johnson
Merck
Colorcon

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.