OXLUMO Drug Patent Profile

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 fourteen patents protecting this drug.

This drug has one hundred and fifty-three patent family members in forty countries.

The generic ingredient in OXLUMO is lumasiran sodium. One supplier is listed for this compound. 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

Summary for OXLUMO

International Patents:	153
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
What excipients (inactive ingredients) are in OXLUMO?	OXLUMO excipients list
DailyMed Link:	OXLUMO at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OXLUMO

NDA:

214103

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

Sponsor	Phase
Alnylam Pharmaceuticals	Phase 2
Alnylam Pharmaceuticals	Phase 3

See all OXLUMO clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for OXLUMO

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for OXLUMO

OXLUMO is protected by fourteen US patents and four FDA Regulatory Exclusivities.

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

FDA Regulatory Exclusivity protecting OXLUMO

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			Y	Y
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103-001	Nov 23, 2020		RX	Yes	Yes
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103-001	Nov 23, 2020		RX	Yes	Yes			Y	Y
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103-001	Nov 23, 2020		RX	Yes	Yes			Y	Y
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103-001	Nov 23, 2020		RX	Yes	Yes			Y	Y
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103-001	Nov 23, 2020		RX	Yes	Yes			Y	Y

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

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Morocco

Norway

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

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
Hungary	S2200011
World Intellectual Property Organization (WIPO)	2015100436
Japan	2019147846	オリゴヌクレオチドの送達剤としての糖質コンジュゲート (CARBOHYDRATE CONJUGATES AS DELIVERY AGENTS FOR OLIGONUCLEOTIDES)
European Patent Office	3141265	CONJUGUÉS GLUCIDIQUES UTILISÉS COMME AGENTS D'ADMINISTRATION POUR DES OLIGONUCLÉOTIDES (CARBOHYDRATE CONJUGATES AS DELIVERY AGENTS FOR OLIGONUCLEOTIDES)
Lithuania	PA2022004
Canada	2708173	LIPIDES DE CIBLAGE (TARGETING LIPIDS)

Supplementary Protection Certificates for OXLUMO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3204015	PA2022004	Lithuania		PRODUCT NAME: LUMASIRANAS; REGISTRATION NO/DATE: EU/120/1496 20201119
3581654	PA2021008,C3581654	Lithuania		PRODUCT NAME: LUMASIRANAS; REGISTRATION NO/DATE: EU/1/20/1496 20201119
3581654	21C1044	France		PRODUCT NAME: LUMASIRAN; REGISTRATION NO/DATE: EU/1/20/1496 20201123
3204015	C03204015/01	Switzerland		PRODUCT NAME: LUMASIRANUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68239 01.12.2021
3581654	C202130048	Spain		PRODUCT NAME: LUMASIRAN; NATIONAL AUTHORISATION NUMBER: EU/1/20/1496; DATE OF AUTHORISATION: 20201119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1496; DATE OF FIRST AUTHORISATION IN EEA: 20201119
3204015	301167	Netherlands		PRODUCT NAME: LUMASIRAN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/20/1496 20201123