~ Buy the OXLUMO (lumasiran sodium) Drug Profile, 2024 PDF Report in the Report Store ~

oxlumo Drug Patent Profile

Which patents cover Oxlumo, 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 sixty-seven patent family members in forty-two 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:	167
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
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103-001	Nov 23, 2020		RX	Yes	Yes

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

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

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
Tunisia	2017000125	COMPOSITIONS AND METHODS FOR INHIBITION OF HAO1 (HYDROXYACID OXIDASE 1 (GLYCOLATE OXIDASE)) GENE EXPRESSION
South Korea	20170083042	HAO1 유전자 발현의 억제를 위한 조성물 및 방법 (HAO1 1 COMPOSITIONS AND METHODS FOR INHIBITION OF HAO1HYDROXYACID OXIDASE 1GLYCOLATE OXIDASE GENE EXPRESSION)
Taiwan	I755351
Uruguay	36357	COMPOSICIONES Y MÉTODOS PARA LA INHIBICIÓN DE LA EXPRESIÓN GÉNICA DE HAO1 (HIDROXIÁCIDO OXIDASA 1 (GLICOLATO OXIDASA))
Portugal	3204015
South Korea	20170099832	변형 이중-가닥 RNA 제제 (- RNA MODIFIED DOUBLE-STRANDED RNA AGENTS)
Japan	6886818

Supplementary Protection Certificates for oxlumo

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
3581654	C03581654/01	Switzerland		PRODUCT NAME: LUMASIRANUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68239 01.12.2021
3204015	2022C/509	Belgium		PRODUCT NAME: LUMASIRAN, INCLUSIEF ZOUTEN ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1496 20201123
3581654	38/2021	Austria		PRODUCT NAME: LUMASIRAN; REGISTRATION NO/DATE: EU/1/20/1496 (MITTEILUNG) 20201123
3204015	CA 2022 00011	Denmark		PRODUCT NAME: LUMASIRAN EVENTUELT I FORM AF ET SALT; REG. NO/DATE: EU/1/20/1496 20201123
3581654	132021000000158	Italy		PRODUCT NAME: LUMASIRAN(OXLUMO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1496, 20201123
3204015	301167	Netherlands		PRODUCT NAME: LUMASIRAN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/20/1496 20201123