Oxlumo Patent Expiration

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. 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 protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US10131907 Glycoconjugates of RNA interference agents
Aug, 2028

(4 years from now)

Active
US8828956 Carbohydrate conjugates as delivery agents for oligonucleotides
Dec, 2028

(4 years from now)

Active
US8106022 Carbohydrate conjugates as delivery agents for oligonucleotides
Dec, 2029

(5 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
US9828606 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
US11401517 Modified double-stranded RNA agents
Aug, 2035

(11 years from now)

Active
US10612024 Modified double-stranded RNA agents
Aug, 2035

(11 years from now)

Active
US10612027 Modified double-stranded RNA agents
Aug, 2035

(11 years from now)

Active
US10478500 Compositions and methods for inhibition of HAO1 (Hydroxyacid Oxidase 1 (Glycolate Oxidase)) gene expression
Oct, 2035

(11 years from now)

Active
US11446380 Compositions and methods for inhibition of HAO1 (hydroxyacid oxidase 1 (glycolate oxidase)) gene expression
Oct, 2035

(11 years from now)

Active
US11261447 Methods for inhibition of HAO1 (hydroxyacid oxidase 1 (glycolate oxidase)) gene expression
Nov, 2038

(14 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).
US10435692 Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA
Dec, 2034

(10 years from now)

Active


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

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

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

Oxlumo has patent protection in a total of 39 countries. It's US patent count contributes only to 35.5% of its total global patent coverage. 3 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Oxlumo.

Family Patents

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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.

Market Authorisation Date:

Oxlumo was approved by FDA for market use on 23 November, 2020.

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 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