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. 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 protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US9567582 | RNA interference mediating small RNA molecules |
Mar, 2021
(3 years ago) |
Expired
|
| US8895721 | 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
|
| US8362231 | 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
|
| US8334373 | Nuclease resistant double-stranded ribonucleic acid |
May, 2025
(9 months from now) | Active |
| US10240152 | Compositions and methods for inhibiting expression of transthyretin |
Oct, 2029
(5 years from now) | Active |
| US8168775 | Compositions and methods for inhibiting expression of transthyretin |
Oct, 2029
(5 years from now) | Active |
| US11079379 | Methods of treating transthyretin (TTR) mediated amyloidosis |
Aug, 2035
(11 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| 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
|
| US9943538 | 2′-methoxy substituted oligomeric compounds and compositions for use in gene modulations |
Nov, 2023
(8 months ago) |
Expired
|
| US9943539 | 2′-methoxy substituted oligomeric compounds and compositions for use in gene modulations |
Nov, 2023
(8 months ago) |
Expired
|
| US8642076 | Lipid containing formulations |
Oct, 2027
(3 years from now) | Active |
| US8822668 | Lipid formulations for nucleic acid delivery |
Apr, 2029
(4 years from now) | Active |
| US9364435 | 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 |
| US8492359 | Lipid formulations for nucleic acid delivery |
Apr, 2029
(4 years from now) | Active |
| US9234196 | Compositions and methods for inhibiting expression of transthyretin |
Oct, 2029
(5 years from now) | Active |
| US8741866 | Compositions and methods for inhibiting expression of transthyretin |
Oct, 2029
(5 years from now) | Active |
| US8802644 | Lipid formulation |
Oct, 2030
(6 years from now) | Active |
| US8158601 | Lipid formulation |
Nov, 2030
(6 years from now) | Active |
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.
Latest Legal Activities on Onpattro's Patents
Given below is the list of recent legal activities going on the following patents of Onpattro.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| 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 has 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 or infringement 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.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8058069 | January, 2019 | Final Written Decision | Arbutus Biopharma Corporation | Moderna Therapeutics, Inc. |
| US9364435 | March, 2018 | FWD Entered | 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 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2025. 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 |
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 |
|---|---|---|---|
| | |||
| 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
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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.
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.
Market Authorisation Date:
Onpattro was approved by FDA for market use on 10 August, 2018.
NCE-1 date:
NCE-1 date is also known as the four year date as it is four years after the original drug approval. 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 |