Oxlumo is a drug owned by Alnylam Pharmaceuticals Inc. It is protected by 14 US drug patents filed from 2021 to 2022 out of which none have expired yet. Oxlumo's patents have been open to challenges since 23 November, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 20, 2038. Details of Oxlumo'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. | |||
| US11261447 | Methods for inhibition of HAO1 (hydroxyacid oxidase 1 (glycolate oxidase)) gene expression |
Nov, 2038
(13 years from now) | Active |
| US11446380 | Compositions and methods for inhibition of HAO1 (hydroxyacid oxidase 1 (glycolate oxidase)) gene expression |
Oct, 2035
(10 years from now) | Active |
| US10478500 | Compositions and methods for inhibition of HAO1 (Hydroxyacid Oxidase 1 (Glycolate Oxidase)) gene expression |
Oct, 2035
(10 years from now) | Active |
| US10612027 | Modified double-stranded RNA agents |
Aug, 2035
(10 years from now) | Active |
| US10612024 | Modified double-stranded RNA agents |
Aug, 2035
(10 years from now) | Active |
| US11401517 | Modified double-stranded RNA agents |
Aug, 2035
(10 years from now) | Active |
| US9828606 | Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA |
Dec, 2034
(10 years from now) | Active |
| US11060093 | Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA |
Dec, 2034
(10 years from now) | Active |
| US10465195 | Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA |
Dec, 2034
(10 years from now) | Active |
| US10487330 | Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA |
Dec, 2034
(10 years from now) | Active |
| US8106022 | Carbohydrate conjugates as delivery agents for oligonucleotides |
Dec, 2029
(5 years from now) | Active |
| US8828956 | Carbohydrate conjugates as delivery agents for oligonucleotides |
Dec, 2028
(4 years from now) | Active |
| US10131907 | Glycoconjugates of RNA interference agents |
Aug, 2028
(3 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10435692 | Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA |
Dec, 2034
(10 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 Oxlumo's patents.
Latest Legal Activities on Oxlumo's Patents
Given below is the list of recent legal activities going on the following patents of Oxlumo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 14 Mar, 2024 | US8828956 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US8828956 |
| Letter from FDA or Dept of Agriculture re PTE application | 19 Oct, 2023 | US10612024 |
| Letter from FDA or Dept of Agriculture re PTE application | 19 Oct, 2023 | US8106022 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 26 Sep, 2023 | US10612024 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 26 Sep, 2023 | US10612027 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 31 Jul, 2023 | US8106022 |
| Second letter to regulating agency to determine regulatory review period | 13 Jun, 2023 | US8828956 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 19 May, 2023 | US10478500 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 20 Apr, 2023 | US10465195 |
FDA has granted several exclusivities to Oxlumo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Oxlumo, 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 Oxlumo.
Exclusivity Information
Oxlumo holds 4 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Oxlumo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-901) | Oct 06, 2025 |
| New Chemical Entity Exclusivity(NCE) | Nov 23, 2025 |
| Orphan Drug Exclusivity(ODE-339) | Nov 23, 2027 |
| Orphan Drug Exclusivity(ODE-415) | Oct 06, 2029 |
US patents provide insights into the exclusivity only within the United States, but Oxlumo 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 Oxlumo's family patents as well as insights into ongoing legal events on those patents.
Oxlumo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Oxlumo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 20, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Oxlumo Generics:
There are no approved generic versions for Oxlumo as of now.
About Oxlumo
Oxlumo is a drug owned by Alnylam Pharmaceuticals Inc. It is used for treating primary hyperoxaluria type 1 (PH1). Oxlumo uses Lumasiran Sodium as an active ingredient. Oxlumo was launched by Alnylam Pharms Inc in 2020.
Can you believe Oxlumo 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:
Oxlumo was approved by FDA for market use on 23 November, 2020.
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 Oxlumo is 23 November, 2020, its NCE-1 date is estimated to be 23 November, 2024.
Active Ingredient:
Oxlumo uses Lumasiran Sodium as the active ingredient. Check out other Drugs and Companies using Lumasiran Sodium ingredient
Treatment:
Oxlumo is used for treating primary hyperoxaluria type 1 (PH1).
Dosage:
Oxlumo is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML) | SOLUTION | Prescription | SUBCUTANEOUS |