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Last Updated: May 25, 2022

OXLUMO Drug Patent Profile


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When do Oxlumo patents expire, and when can generic versions of Oxlumo launch?

Oxlumo is a drug marketed by Alnylam Pharms Inc and is included in one NDA. There are twelve patents protecting this drug.

This drug has one hundred and twenty-six patent family members in thirty-six countries.

The generic ingredient in OXLUMO is lumasiran sodium. Additional details are available on the lumasiran sodium profile page.

DrugPatentWatch® Generic Entry Outlook for Oxlumo

Oxlumo will be eligible for patent challenges on November 23, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 9, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for OXLUMO
International Patents:126
US Patents:12
Applicants:1
NDAs:1
Clinical Trials: 2
What excipients (inactive ingredients) are in OXLUMO?OXLUMO excipients list
DailyMed Link:OXLUMO at DailyMed
Drug patent expirations by year for OXLUMO
DrugPatentWatch® Estimated Generic Entry Opportunity Date for OXLUMO
Generic Entry Date for OXLUMO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;SUBCUTANEOUS

*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 OXLUMO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Alnylam PharmaceuticalsPhase 2
Alnylam PharmaceuticalsPhase 3

See all OXLUMO clinical trials

US Patents and Regulatory Information for OXLUMO

OXLUMO is protected by twelve US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of OXLUMO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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 OXLUMO

Glycoconjugates of RNA interference agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)

Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)

Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)

Compositions and methods for inhibition of HAO1 (Hydroxyacid Oxidase 1 (Glycolate Oxidase)) gene expression
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)

Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)

Modified double-stranded RNA agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)

Modified double-stranded RNA agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)

Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)

Methods for inhibition of HAO1 (hydroxyacid oxidase 1 (glycolate oxidase)) gene expression
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)

Carbohydrate conjugates as delivery agents for oligonucleotides
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)

Carbohydrate conjugates as delivery agents for oligonucleotides
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)

Methods and compositions for the specific inhibition of glycolate oxidase (HAO1) by double-stranded RNA
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting OXLUMO

TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1) TO LOWER URINARY OXALATE LEVELS IN PEDIATRIC AND ADULT PATIENTS
Exclusivity Expiration: See Plans and Pricing

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 OXLUMO lumasiran sodium SOLUTION;SUBCUTANEOUS 214103-001 Nov 23, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Alnylam Pharms Inc OXLUMO lumasiran sodium SOLUTION;SUBCUTANEOUS 214103-001 Nov 23, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Alnylam Pharms Inc OXLUMO lumasiran sodium SOLUTION;SUBCUTANEOUS 214103-001 Nov 23, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Alnylam Pharms Inc OXLUMO lumasiran sodium SOLUTION;SUBCUTANEOUS 214103-001 Nov 23, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Alnylam Pharms Inc OXLUMO lumasiran sodium SOLUTION;SUBCUTANEOUS 214103-001 Nov 23, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for OXLUMO

When does loss-of-exclusivity occur for OXLUMO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 2257
Estimated Expiration: See Plans and Pricing

Australia

Patent: 15330726
Estimated Expiration: See Plans and Pricing

Patent: 21269372
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2017006469
Estimated Expiration: See Plans and Pricing

Canada

Patent: 63843
Estimated Expiration: See Plans and Pricing

Chile

Patent: 17000872
Estimated Expiration: See Plans and Pricing

China

Patent: 8064154
Estimated Expiration: See Plans and Pricing

Patent: 3599389
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 17004728
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 170190
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0211971
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 04015
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 017000094
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 17028310
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 7115
Estimated Expiration: See Plans and Pricing

Patent: 1790789
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 04015
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1276
Estimated Expiration: See Plans and Pricing

Japan

Patent: 36988
Estimated Expiration: See Plans and Pricing

Patent: 17532038
Estimated Expiration: See Plans and Pricing

Patent: 21019609
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 0200115
Estimated Expiration: See Plans and Pricing

Patent: 58
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 04015
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 17004634
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 049
Estimated Expiration: See Plans and Pricing

Peru

Patent: 171763
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 017500669
Estimated Expiration: See Plans and Pricing

Poland

Patent: 04015
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 04015
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 854
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201913756Q
Estimated Expiration: See Plans and Pricing

Patent: 201702836P
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1702071
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 170083042
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 1619382
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 17000125
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 357
Estimated Expiration: See Plans and Pricing

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 OXLUMO around the world.

Country Patent Number Title Estimated Expiration
Denmark 3581654 See Plans and Pricing
Ecuador SP17028310 Composiciones y métodos para inhibir la expresión del gen HAO1 (hidroxiácido-oxidasa 1 (glicolato-oxidasa)) See Plans and Pricing
European Patent Office 2229186 CONJUGUÉS GLUCIDIQUES UTILISÉS EN TANT QU'AGENTS D'ADMINISTRATION POUR DES OLIGONUCLÉOTIDES (CARBOHYDRATE CONJUGATES AS DELIVERY AGENTS FOR OLIGONUCLEOTIDES) See Plans and Pricing
Lithuania PA2021008 See Plans and Pricing
European Patent Office 3156077 LIPIDES DE CIBLAGE (TARGETING LIPIDS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OXLUMO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3581654 CA 2021 00038 Denmark See Plans and Pricing PRODUCT NAME: LUMASIRAN; REG. NO/DATE: EU/1/20/1496 20201123
3581654 301132 Netherlands See Plans and Pricing PRODUCT NAME: LUMASIRAN; REGISTRATION NO/DATE: EU/1/20/1496 20201123
3581654 LUC00218 Luxembourg See Plans and Pricing PRODUCT NAME: LUMASIRAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1496 20201123
3581654 2021C/534 Belgium See Plans and Pricing PRODUCT NAME: LUMASIRAN; AUTHORISATION NUMBER AND DATE: EU1/20/1496 20201123
3581654 122021000053 Germany See Plans and Pricing PRODUCT NAME: LUMASIRAN; REGISTRATION NO/DATE: EU/1/20/1496 20201119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
Johnson and Johnson
Merck
Medtronic
Dow

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.