Onpattro Patent Expiration

Onpattro is a drug owned by Alnylam Pharmaceuticals Inc. It is protected by 24 US drug patents filed from 2018 to 2021. Out of these, 14 drug patents are active and 10 have expired. Onpattro's patents have been open to challenges since 10 August, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 27, 2035. Details of Onpattro's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US11079379 Methods of treating transthyretin (TTR) mediated amyloidosis
Aug, 2035

(10 years from now)

Active
US8168775 Compositions and methods for inhibiting expression of transthyretin
Oct, 2029

(4 years from now)

Active
US10240152 Compositions and methods for inhibiting expression of transthyretin
Oct, 2029

(4 years from now)

Active
US8334373 Nuclease resistant double-stranded ribonucleic acid
May, 2025

(5 months from now)

Active
US8895721 RNA interference mediating small RNA molecules
Mar, 2021

(3 years ago)

Expired
US8552171 RNA sequence-specific mediators of RNA interference
Mar, 2021

(3 years ago)

Expired
US8362231 RNA interference mediating small RNA molecules
Mar, 2021

(3 years ago)

Expired
US8895718 RNA interference mediating small RNA molecules
Mar, 2021

(3 years ago)

Expired
US8372968 RNA interference mediating small RNA molecules
Mar, 2021

(3 years ago)

Expired
US9567582 RNA interference mediating small RNA molecules
Mar, 2021

(3 years ago)

Expired
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8158601 Lipid formulation
Nov, 2030

(5 years from now)

Active
US8802644 Lipid formulation
Oct, 2030

(5 years from now)

Active
US9234196 Compositions and methods for inhibiting expression of transthyretin
Oct, 2029

(4 years from now)

Active
US8741866 Compositions and methods for inhibiting expression of transthyretin
Oct, 2029

(4 years from now)

Active
US9364435 Lipid formulations for nucleic acid delivery
Apr, 2029

(4 years from now)

Active
US8822668 Lipid formulations for nucleic acid delivery
Apr, 2029

(4 years from now)

Active
US8492359 Lipid formulations for nucleic acid delivery
Apr, 2029

(4 years from now)

Active
US8058069 Lipid formulations for nucleic acid delivery
Apr, 2029

(4 years from now)

Active
US11141378 Lipid formulations for nucleic acid delivery
Apr, 2029

(4 years from now)

Active
US8642076 Lipid containing formulations
Oct, 2027

(2 years from now)

Active
US9943539 2′-methoxy substituted oligomeric compounds and compositions for use in gene modulations
Nov, 2023

(1 year, 1 month ago)

Expired
US9943538 2′-methoxy substituted oligomeric compounds and compositions for use in gene modulations
Nov, 2023

(1 year, 1 month ago)

Expired
US9193753 RNA sequence-specific mediators of RNA interference
Mar, 2021

(3 years ago)

Expired
US8778902 RNA interference mediating small RNA molecules
Mar, 2021

(3 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Onpattro's patents.

Given below is the list of recent legal activities going on the following patents of Onpattro.

Activity Date Patent Number
Patent litigations
Notice of Final Determination -Election Required 26 Jun, 2024 US9234196
Notice of Final Determination -Election Required 26 Jun, 2024 US8168775
Notice of Final Determination -Election Required 26 Jun, 2024 US8741866
Payment of Maintenance Fee, 12th Year, Large Entity 28 May, 2024 US8334373
FDA Final Eligibility Letter 30 Jan, 2024 US9234196
FDA Final Eligibility Letter 30 Jan, 2024 US8168775
FDA Final Eligibility Letter 30 Jan, 2024 US8741866
Expire Patent 01 Jan, 2024 US9193753
Payment of Maintenance Fee, 8th Year, Large Entity 08 Dec, 2023 US9364435 (Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 17 Oct, 2023 US8168775


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Onpattro and ongoing litigations to help you estimate the early arrival of Onpattro generic.

Onpattro's Litigations

Onpattro been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Mar 05, 2018, against patent number US9364435. The petitioner Moderna Therapeutics, Inc., challenged the validity of this patent, with Arbutus Biopharma Corporation as the respondent. Click below to track the latest information on how companies are challenging Onpattro's patents.

Last updated on December 10, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8058069 January, 2019 Final Written Decision
(23 Jul, 2020)
Arbutus Biopharma Corporation Moderna Therapeutics, Inc.
US9364435 March, 2018 FWD Entered
(11 Sep, 2019)
Arbutus Biopharma Corporation Moderna Therapeutics, Inc.


FDA has granted some exclusivities to Onpattro. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Onpattro, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Onpattro.

Exclusivity Information

Onpattro holds 3 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Onpattro's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Aug 10, 2023
Orphan Drug Exclusivity(ODE-197) Aug 10, 2025
M(M-270) Jan 13, 2026

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Several oppositions have been filed on Onpattro's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Onpattro's generic, the next section provides detailed information on ongoing and past EP oppositions related to Onpattro patents.

Onpattro's Oppositions Filed in EPO

Onpattro has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 05, 2018, by Moderna Therapeutics, Inc.. This opposition was filed on patent number EP09731866A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP09731866A Apr, 2018 Merck Sharp & Dohme Corporation Granted and Under Opposition
EP09731866A Apr, 2018 Moderna Therapeutics, Inc. Granted and Under Opposition


US patents provide insights into the exclusivity only within the United States, but Onpattro is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Onpattro's family patents as well as insights into ongoing legal events on those patents.

Onpattro's Family Patents

Onpattro has patent protection in a total of 31 countries. It's US patent count contributes only to 23.6% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Onpattro.

Family Patents

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Generic Launch

Generic Release Date:

Onpattro's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 27, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Onpattro Generics:

There are no approved generic versions for Onpattro as of now.

Alternative Brands for Onpattro

Onpattro which is used for treating hereditary transthyretin-mediated amyloidosis polyneuropathy., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Astrazeneca Ab
Wainua (autoinjector) Used for treating polyneuropathy associated with hereditary transthyretin-mediated amyloidosis.





About Onpattro

Onpattro is a drug owned by Alnylam Pharmaceuticals Inc. It is used for treating hereditary transthyretin-mediated amyloidosis polyneuropathy. Onpattro uses Patisiran Sodium as an active ingredient. Onpattro was launched by Alnylam Pharms Inc in 2018.

Can you believe Onpattro received compensation for the extended wait time during the regulatory approval process?

A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.

Approval Date:

Onpattro was approved by FDA for market use on 10 August, 2018.

NCE-1 date:

NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Onpattro is 10 August, 2018, its NCE-1 date is estimated to be 10 August, 2022.

Active Ingredient:

Onpattro uses Patisiran Sodium as the active ingredient. Check out other Drugs and Companies using Patisiran Sodium ingredient

Treatment:

Onpattro is used for treating hereditary transthyretin-mediated amyloidosis polyneuropathy.

Dosage:

Onpattro is available in solution form for intravenous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 10MG BASE/5ML (EQ 2MG BASE/ML) SOLUTION Prescription INTRAVENOUS