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Last Updated: March 28, 2024

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ONPATTRO Drug Patent 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 fourteen patents protecting this drug.

This drug has two hundred and forty-one patent family members in thirty-one 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.

DrugPatentWatch® Generic Entry Outlook for Onpattro

Onpattro was eligible for patent challenges on August 10, 2022.

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.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for ONPATTRO
Drug patent expirations by year for ONPATTRO
Drug Prices for ONPATTRO

See drug prices for ONPATTRO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 Clinical Trials for ONPATTRO

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

SponsorPhase
Alnylam PharmaceuticalsEarly Phase 1
Austin Neuromuscular CenterEarly Phase 1

See all ONPATTRO clinical trials

US Patents and Regulatory Information for ONPATTRO

ONPATTRO is protected by fourteen US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ONPATTRO is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ONPATTRO

Compositions and methods for inhibiting expression of transthyretin
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS

Methods of treating transthyretin (TTR) mediated amyloidosis
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS

Lipid formulations for nucleic acid delivery
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Lipid formulations for nucleic acid delivery
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Lipid formulation
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS

Compositions and methods for inhibiting expression of transthyretin
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS

Nuclease resistant double-stranded ribonucleic acid
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Lipid formulations for nucleic acid delivery
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Lipid containing formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compositions and methods for inhibiting expression of transthyretin
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS

Lipid formulation
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS

Lipid formulations for nucleic acid delivery
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS

Compositions and methods for inhibiting expression of transthyretin
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS

Lipid formulations for nucleic acid delivery
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS

FDA Regulatory Exclusivity protecting ONPATTRO

INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
Exclusivity Expiration: ⤷  Try a Trial

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

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

International Patents for ONPATTRO

When does loss-of-exclusivity occur for ONPATTRO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 10259984
Estimated Expiration: ⤷  Try a Trial

Patent: 17202702
Estimated Expiration: ⤷  Try a Trial

Patent: 19204984
Estimated Expiration: ⤷  Try a Trial

Patent: 21201228
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 64609
Estimated Expiration: ⤷  Try a Trial

Patent: 14827
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2625696
Estimated Expiration: ⤷  Try a Trial

Patent: 4873464
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0181221
Estimated Expiration: ⤷  Try a Trial

Patent: 0211619
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 20641
Estimated Expiration: ⤷  Try a Trial

Patent: 24769
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 40183
Estimated Expiration: ⤷  Try a Trial

Patent: 31076
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 4960
Estimated Expiration: ⤷  Try a Trial

Patent: 8860
Estimated Expiration: ⤷  Try a Trial

Patent: 1190306
Estimated Expiration: ⤷  Try a Trial

Patent: 1690312
Estimated Expiration: ⤷  Try a Trial

Patent: 1791744
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 40183
Estimated Expiration: ⤷  Try a Trial

Patent: 31076
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 12620
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 38796
Estimated Expiration: ⤷  Try a Trial

Patent: 56773
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 6876
Estimated Expiration: ⤷  Try a Trial

Patent: 4945
Estimated Expiration: ⤷  Try a Trial

Patent: 4826
Estimated Expiration: ⤷  Try a Trial

Patent: 0077
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 19291
Estimated Expiration: ⤷  Try a Trial

Patent: 32321
Estimated Expiration: ⤷  Try a Trial

Patent: 59719
Estimated Expiration: ⤷  Try a Trial

Patent: 92144
Estimated Expiration: ⤷  Try a Trial

Patent: 12530059
Estimated Expiration: ⤷  Try a Trial

Patent: 15232048
Estimated Expiration: ⤷  Try a Trial

Patent: 17122126
Estimated Expiration: ⤷  Try a Trial

Patent: 18141019
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 40183
Estimated Expiration: ⤷  Try a Trial

Patent: 31076
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 2785
Estimated Expiration: ⤷  Try a Trial

Patent: 7665
Estimated Expiration: ⤷  Try a Trial

Patent: 11013320
Estimated Expiration: ⤷  Try a Trial

Patent: 19010340
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 6958
Estimated Expiration: ⤷  Try a Trial

Patent: 2843
Estimated Expiration: ⤷  Try a Trial

Patent: 2719
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 40183
Estimated Expiration: ⤷  Try a Trial

Patent: 31076
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 40183
Estimated Expiration: ⤷  Try a Trial

Patent: 31076
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 6786
Estimated Expiration: ⤷  Try a Trial

Patent: 201403054S
Estimated Expiration: ⤷  Try a Trial

Patent: 201912450X
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 40183
Estimated Expiration: ⤷  Try a Trial

Patent: 31076
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1766408
Estimated Expiration: ⤷  Try a Trial

Patent: 1987962
Estimated Expiration: ⤷  Try a Trial

Patent: 2066189
Estimated Expiration: ⤷  Try a Trial

Patent: 2205886
Estimated Expiration: ⤷  Try a Trial

Patent: 2374518
Estimated Expiration: ⤷  Try a Trial

Patent: 120081065
Estimated Expiration: ⤷  Try a Trial

Patent: 170091798
Estimated Expiration: ⤷  Try a Trial

Patent: 190065474
Estimated Expiration: ⤷  Try a Trial

Patent: 200006176
Estimated Expiration: ⤷  Try a Trial

Patent: 210008938
Estimated Expiration: ⤷  Try a Trial

Patent: 220038506
Estimated Expiration: ⤷  Try a Trial

Patent: 230098713
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 89168
Estimated Expiration: ⤷  Try a Trial

Patent: 01627
Estimated Expiration: ⤷  Try a Trial

Turkey

Patent: 1811076
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ONPATTRO around the world.

Country Patent Number Title Estimated Expiration
Poland 2937418 ⤷  Try a Trial
New Zealand 553687 RNA sequence-specific mediators of RNA interference ⤷  Try a Trial
Mexico 2009003548 FORMULACIONES QUE CONTIENEN LIPIDOS. (LIPID CONTAINING FORMULATIONS.) ⤷  Try a Trial
Eurasian Patent Organization 036772 КОМПОЗИЦИИ И СПОСОБЫ ДЛЯ ИНГИБИРОВАНИЯ ЭКСПРЕССИИ ТРАНСТИРЕТИНА (COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF TRANSTHYRETIN) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ONPATTRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2937418 SPC/GB19/005 United Kingdom ⤷  Try a Trial PRODUCT NAME: PATISIRAN; REGISTERED: UK EU/1/18/1320(FOR NI) 20180827; UK PLGB 50597/0002 20180827
2937418 LUC00098 Luxembourg ⤷  Try a Trial PRODUCT NAME: PATISIRAN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (ONPATTRO ); AUTHORISATION NUMBER AND DATE: EU/1/18/1320 20180829
2937418 PA2019501 Lithuania ⤷  Try a Trial PRODUCT NAME: PATISIRANAS; REGISTRATION NO/DATE: EU/1/18/1320 20180827
2937418 300965 Netherlands ⤷  Try a Trial PRODUCT NAME: PATISIRAN; REGISTRATION 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.