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Last Updated: August 10, 2022

GIVLAARI Drug Patent Profile


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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 four hundred and one patent family members in forty-two countries.

The generic ingredient in GIVLAARI is givosiran sodium. 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

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Summary for GIVLAARI
International Patents:401
US Patents:13
Applicants:1
NDAs: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
Drug patent expirations by year for GIVLAARI
Drug Prices for GIVLAARI

See drug prices for GIVLAARI

DrugPatentWatch® Estimated Generic Entry Opportunity Date for GIVLAARI
Generic Entry Date for GIVLAARI*:
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 GIVLAARI

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

SponsorPhase
Alnylam PharmaceuticalsPhase 3

See all GIVLAARI clinical trials

US Patents and Regulatory Information for GIVLAARI

GIVLAARI is protected by thirteen US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of GIVLAARI 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 GIVLAARI

Compositions and methods for inhibiting expression of the ALAS1 gene
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACUTE HEPATIC PORPHYRIA

Compositions and methods for inhibiting expression of the ALAS1 gene
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACUTE HEPATIC PORPHYRIA

Glycoconjugates of RNA interference agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACUTE HEPATIC PORPHYRIA

Therapeutic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and methods for inhibiting expression of the ALAS1 gene
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACUTE HEPATIC PORPHYRIA

Carbohydrate conjugates as delivery agents for oligonucleotides
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACUTE HEPATIC PORPHYRIA

Compositions and methods for inhibiting expression of a target gene
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACUTE HEPATIC PORPHYRIA

Carbohydrate conjugates as delivery agents for oligonucleotides
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACUTE HEPATIC PORPHYRIA

Compositions and methods for inhibiting expression of the ALAS1 gene
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACUTE HEPATIC PORPHYRIA

Compositions comprising alternating 2'-modified nucleosides for use in gene modulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and methods for inhibiting expression of the ALAS1 gene
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACUTE HEPATIC PORPHYRIA

Compositions comprising alternating 2'-modified nucleosides for use in gene modulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACUTE HEPATIC PORPHYRIA

Therapeutic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting GIVLAARI

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

INDICATED FOR THE TREATMENT OF ADULTS WITH ACUTE HEPATIC PORPHYRIA (AHP)
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 GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 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 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

Patent: 7920
Estimated Expiration: See Plans and Pricing

Patent: 8658
Estimated Expiration: See Plans and Pricing

Australia

Patent: 14331604
Estimated Expiration: See Plans and Pricing

Patent: 20286311
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2016007226
Estimated Expiration: See Plans and Pricing

Canada

Patent: 25357
Estimated Expiration: See Plans and Pricing

Chile

Patent: 16000772
Estimated Expiration: See Plans and Pricing

Patent: 18000158
Estimated Expiration: See Plans and Pricing

China

Patent: 5980559
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 160195
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0200822
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 52628
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 016000073
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 6477
Estimated Expiration: See Plans and Pricing

Patent: 1690685
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 52628
Estimated Expiration: See Plans and Pricing

Patent: 93463
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 1600066
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 21738
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 49227
Estimated Expiration: See Plans and Pricing

Patent: 000034
Estimated Expiration: See Plans and Pricing

Israel

Patent: 4749
Estimated Expiration: See Plans and Pricing

Patent: 2747
Estimated Expiration: See Plans and Pricing

Japan

Patent: 13227
Estimated Expiration: See Plans and Pricing

Patent: 16539623
Estimated Expiration: See Plans and Pricing

Patent: 20096582
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 052628
Estimated Expiration: See Plans and Pricing

Patent: 2020527
Estimated Expiration: See Plans and Pricing

Patent: 52628
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 16004319
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 000
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 1061
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 8995
Estimated Expiration: See Plans and Pricing

Patent: 7749
Estimated Expiration: See Plans and Pricing

Peru

Patent: 161130
Estimated Expiration: See Plans and Pricing

Patent: 211249
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 016500574
Estimated Expiration: See Plans and Pricing

Poland

Patent: 52628
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 52628
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201910929Q
Estimated Expiration: See Plans and Pricing

Patent: 201602631X
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 52628
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1602931
Estimated Expiration: See Plans and Pricing

Patent: 1802919
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2307389
Estimated Expiration: See Plans and Pricing

Patent: 160079793
Estimated Expiration: See Plans and Pricing

Patent: 210122877
Estimated Expiration: See Plans and Pricing

Spain

Patent: 04510
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 94080
Estimated Expiration: See Plans and Pricing

Patent: 1524991
Estimated Expiration: See Plans and Pricing

Patent: 2106697
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 16000114
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 4961
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 GIVLAARI around the world.

Country Patent Number Title Estimated Expiration
Japan 6471901 See Plans and Pricing
Canada 2488224 CONJUGUES D'ARNI (IRNA CONJUGATES) See Plans and Pricing
Germany 10160151 See Plans and Pricing
Australia 2003290597 MODIFIED OLIGONUCLEOTIDES FOR USE IN RNA INTERFERENCE See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for GIVLAARI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3052628 LUC00175 Luxembourg See Plans and Pricing PRODUCT NAME: GIVOSIRAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1428 20200304
3052628 PA2020527 Lithuania See Plans and Pricing PRODUCT NAME: GIVOSIRANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1428 20200302
3052628 C03052628/01 Switzerland See Plans and Pricing PRODUCT NAME: GIVOSIRAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67895 29.03.2021
3052628 20C1040 France See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Merck
Johnson and Johnson
Dow
AstraZeneca
Colorcon

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.