You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: October 11, 2024

~ Buy the ONPATTRO (patisiran sodium) Drug Profile, 2024 PDF Report in the Report Store ~

onpattro Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Onpattro patents expire, and what generic alternatives are available?

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-seven 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

< Available with Subscription >

  Sign Up

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for onpattro?
  • What are the global sales for onpattro?
  • What is Average Wholesale Price for onpattro?
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 two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of onpattro is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS

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

Lipid formulations for nucleic acid delivery
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Lipid formulations for nucleic acid delivery
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Lipid formulation
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS

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

Nuclease resistant double-stranded ribonucleic acid
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Lipid formulations for nucleic acid delivery
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Lipid containing formulations
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

Lipid formulation
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS

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

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

Lipid formulations for nucleic acid delivery
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up

INFORMATION ADDED TO CLINICAL PHARMACOLOGY SECTION
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  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 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
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
>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 ⤷  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 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
Patent: Improved lipid formulation
Estimated Expiration: ⤷  Sign Up

Patent: 17202702
Patent: Improved lipid formulation
Estimated Expiration: ⤷  Sign Up

Patent: 19204984
Patent: Improved lipid formulation
Estimated Expiration: ⤷  Sign Up

Patent: 21201228
Patent: Improved lipid formulation
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 64609
Patent: FORMULATION LIPIDIQUE AMELIOREE (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷  Sign Up

Patent: 14827
Patent: LIPIDE CATIONIQUE AMELIORE DE FORMULE I (IMPROVED CATIONIC LIPID OF FORMULA I)
Estimated Expiration: ⤷  Sign Up

China

Patent: 2625696
Patent: Improved lipid formulation
Estimated Expiration: ⤷  Sign Up

Patent: 4873464
Patent: Improved lipid formulation
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0181221
Estimated Expiration: ⤷  Sign Up

Patent: 0211619
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 20641
Estimated Expiration: ⤷  Sign Up

Patent: 24769
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 40183
Estimated Expiration: ⤷  Sign Up

Patent: 31076
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 4960
Patent: УЛУЧШЕННАЯ ЛИПИДНАЯ КОМПОЗИЦИЯ (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷  Sign Up

Patent: 8860
Patent: УЛУЧШЕННАЯ ЛИПИДНАЯ КОМПОЗИЦИЯ (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷  Sign Up

Patent: 1190306
Patent: УЛУЧШЕННАЯ ЛИПИДНАЯ КОМПОЗИЦИЯ
Estimated Expiration: ⤷  Sign Up

Patent: 1690312
Patent: УЛУЧШЕННАЯ ЛИПИДНАЯ КОМПОЗИЦИЯ
Estimated Expiration: ⤷  Sign Up

Patent: 1791744
Patent: УЛУЧШЕННАЯ ЛИПИДНАЯ КОМПОЗИЦИЯ
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 40183
Patent: FORMULATION LIPIDIQUE AMÉLIORÉE (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷  Sign Up

Patent: 31076
Patent: FORMULATION LIPIDIQUE AMÉLIORÉE (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 12620
Patent: 改進的脂質製劑 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 38796
Estimated Expiration: ⤷  Sign Up

Patent: 56773
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 6876
Patent: ליפיד קטיוני, פורמולציות ליפידיות הכוללות אותו ושימושן בהכנת גורמים טיפוליים למתן לתאים (Cationic lipid, lipid formulations comprising same and use thereof in the preparation of therapeutic agents for delivering to cells)
Estimated Expiration: ⤷  Sign Up

Patent: 4945
Patent: ליפיד קטיוני, פורמולציות ליפידיות הכוללות אותו ושימושן בהכנת גורמים טיפוליים למתן לתאים (Cationic lipid, lipid formulations comprising same and use thereof in the preparation of therapeutic agents for delivering to cells)
Estimated Expiration: ⤷  Sign Up

Patent: 4826
Patent: פורמולציה ליפידית משופרת (Improved lipid formulation)
Estimated Expiration: ⤷  Sign Up

Patent: 0077
Patent: פורמולציה ליפידית משופרת (Improved lipid formulation)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 19291
Estimated Expiration: ⤷  Sign Up

Patent: 32321
Estimated Expiration: ⤷  Sign Up

Patent: 59719
Estimated Expiration: ⤷  Sign Up

Patent: 92144
Estimated Expiration: ⤷  Sign Up

Patent: 12530059
Estimated Expiration: ⤷  Sign Up

Patent: 15232048
Patent: 改善された脂質製剤 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷  Sign Up

Patent: 17122126
Patent: 改善された脂質製剤 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷  Sign Up

Patent: 18141019
Patent: 改善された脂質製剤 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 40183
Estimated Expiration: ⤷  Sign Up

Patent: 31076
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 2785
Patent: FORMULACION MEJORADA DE LIPIDO. (IMPROVED LIPID FORMULATION.)
Estimated Expiration: ⤷  Sign Up

Patent: 7665
Patent: FORMULACIÓN MEJORADA DE LÍPIDO. (IMPROVED LIPID FORMULATION.)
Estimated Expiration: ⤷  Sign Up

Patent: 11013320
Patent: FORMULACION MEJORADA DE LIPIDO. (IMPROVED LIPID FORMULATION.)
Estimated Expiration: ⤷  Sign Up

Patent: 19010340
Patent: FORMULACION MEJORADA DE LIPIDO. (IMPROVED LIPID FORMULATION.)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 6958
Patent: Improved lipid formulation
Estimated Expiration: ⤷  Sign Up

Patent: 2843
Patent: Improved lipid formulation
Estimated Expiration: ⤷  Sign Up

Patent: 2719
Patent: Improved lipid formulation
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 40183
Estimated Expiration: ⤷  Sign Up

Patent: 31076
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 40183
Estimated Expiration: ⤷  Sign Up

Patent: 31076
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 6786
Patent: IMPROVED LIPID FORMULATION
Estimated Expiration: ⤷  Sign Up

Patent: 201403054S
Patent: IMPROVED LIPID FORMULATION
Estimated Expiration: ⤷  Sign Up

Patent: 201912450X
Patent: IMPROVED LIPID FORMULATION
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 40183
Estimated Expiration: ⤷  Sign Up

Patent: 31076
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1766408
Estimated Expiration: ⤷  Sign Up

Patent: 1987962
Estimated Expiration: ⤷  Sign Up

Patent: 2066189
Estimated Expiration: ⤷  Sign Up

Patent: 2205886
Estimated Expiration: ⤷  Sign Up

Patent: 2374518
Estimated Expiration: ⤷  Sign Up

Patent: 120081065
Patent: IMPROVED LIPID FORMULATION
Estimated Expiration: ⤷  Sign Up

Patent: 170091798
Patent: 향상된 지질 조성물 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷  Sign Up

Patent: 190065474
Patent: 향상된 지질 조성물 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷  Sign Up

Patent: 200006176
Patent: 향상된 지질 조성물 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷  Sign Up

Patent: 210008938
Patent: 향상된 지질 조성물 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷  Sign Up

Patent: 220038506
Patent: 향상된 지질 조성물 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷  Sign Up

Patent: 230098713
Patent: 향상된 지질 조성물 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 89168
Estimated Expiration: ⤷  Sign Up

Patent: 01627
Estimated Expiration: ⤷  Sign Up

Turkey

Patent: 1811076
Estimated Expiration: ⤷  Sign Up

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
South Korea 20080069602 ⤷  Sign Up
Norway 2019004 ⤷  Sign Up
Australia 2003291682 2'-METHOXY SUBSTITUTED OLIGOMERIC COMPOUNDS AND COMPOSITIONS FOR USE IN GENE MODULATIONS ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2004042029 ⤷  Sign Up
Canada 2739895 COMPOSITIONS ET PROCEDES POUR INHIBER L'EXPRESSION DE LA TRANSTHYRETINE (COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF TRANSTHYRETIN) ⤷  Sign Up
Hong Kong 1160669 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for onpattro

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

Make Better Decisions: Try a trial or see plans & pricing

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.