GIVLAARI Drug Patent Profile

Which patents cover Givlaari, and when can generic versions of Givlaari launch?

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

This drug has three hundred and eleven patent family members in forty-two countries.

The generic ingredient in GIVLAARI is givosiran sodium. One supplier is listed for this compound. Additional details are available on the givosiran sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Givlaari

Givlaari will be eligible for patent challenges on November 20, 2023. 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 3, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for GIVLAARI

International Patents:	311
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Drug Prices:	Drug price information for GIVLAARI
What excipients (inactive ingredients) are in GIVLAARI?	GIVLAARI excipients list
DailyMed Link:	GIVLAARI at DailyMed

See drug prices for GIVLAARI

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

NDA:

212194

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 GIVLAARI

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

Sponsor	Phase
Alnylam Pharmaceuticals	Phase 3

See all GIVLAARI clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for GIVLAARI

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 GIVLAARI

GIVLAARI is protected by thirteen US patents and two 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 GIVLAARI

FDA Regulatory Exclusivity protecting GIVLAARI

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	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019		RX	Yes	Yes
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019		RX	Yes	Yes			Y	Y
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019		RX	Yes	Yes			Y	Y
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019		RX	Yes	Yes				Y
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019		RX	Yes	Yes			Y	Y
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019		RX	Yes	Yes
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019		RX	Yes	Yes			Y	Y

Expired US Patents for GIVLAARI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019

International Patents for GIVLAARI

When does loss-of-exclusivity occur for GIVLAARI?

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

Argentina

Australia

Brazil

Canada

Chile

China

Costa Rica

Croatia

Denmark

Dominican Republic

Eurasian Patent Organization

European Patent Office

Guatemala

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

Morocco

Netherlands

New Zealand

Peru

Philippines

Poland

Portugal

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

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 GIVLAARI around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	4991288
Russian Federation	2019111696	КОМПОЗИЦИИ И СПОСОБЫ ИНГИБИРОВАНИЯ ЭКСПРЕССИИ ГЕНА ALAS1
Canada	3169218	COMPOSITIONS ET PROCEDES PERMETTANT D'INHIBER L'EXPRESSION DU GENE ALAS1 (COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE)
Germany	50015501
Japan	6542853
European Patent Office	1438405
Japan	2009100758	METHOD AND MEDICINE FOR INHIBITING EXPRESSION OF SPECIFIC GENE

Supplementary Protection Certificates for GIVLAARI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3052628	724	Finland
3052628	SPC/GB20/042	United Kingdom		PRODUCT NAME: GIVOSIRAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/20/1428 (NI) 20200304; UK PLGB 50597/0004 20200304
3052628	PA2020527	Lithuania		PRODUCT NAME: GIVOSIRANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1428 20200302
3052628	2020C/532	Belgium		PRODUCT NAME: GIVOSIRAN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1428 20200304
3052628	2020029	Norway		PRODUCT NAME: GIVOSIRAN ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV; REG. NO/DATE: EU/1/20/1428 20200306
3052628	20C1040	France		PRODUCT NAME: GIVOSIRAN OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; NAT. REGISTRATION NO/DATE: EU/1/20/1428 20200304; FIRST REGISTRATION: - EU/1/20/1428 20200304
3052628	2090037-9	Sweden		PRODUCT NAME: GIVOSIRAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/20/1428 20200304