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Last Updated: November 17, 2024

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GIVLAARI Drug Patent Profile


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DrugPatentWatch® Generic Entry Outlook for Givlaari

Givlaari was eligible for patent challenges on November 20, 2023.

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:324
US Patents:12
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
Drug patent expirations by year for GIVLAARI
Drug Prices for GIVLAARI

See drug prices for GIVLAARI

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 twelve US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of GIVLAARI is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACUTE HEPATIC PORPHYRIA

Compositions and methods for inhibiting expression of the ALAS1 gene
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACUTE HEPATIC PORPHYRIA

Glycoconjugates of RNA interference agents
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACUTE HEPATIC PORPHYRIA

Therapeutic compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compositions and methods for inhibiting expression of the ALAS1 gene
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACUTE HEPATIC PORPHYRIA


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Carbohydrate conjugates as delivery agents for oligonucleotides
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACUTE HEPATIC PORPHYRIA

Carbohydrate conjugates as delivery agents for oligonucleotides
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACUTE HEPATIC PORPHYRIA

Compositions and methods for inhibiting expression of the ALAS1 gene
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACUTE HEPATIC PORPHYRIA

Compositions comprising alternating 2'-modified nucleosides for use in gene modulation
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compositions and methods for inhibiting expression of the ALAS1 gene
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACUTE HEPATIC PORPHYRIA

Therapeutic compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting GIVLAARI

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

INDICATED FOR THE TREATMENT OF ADULTS WITH ACUTE HEPATIC PORPHYRIA (AHP)
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 ⤷  Sign Up ⤷  Sign Up
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 ⤷  Sign Up ⤷  Sign Up
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 ⤷  Sign Up ⤷  Sign Up
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 ⤷  Sign Up ⤷  Sign Up
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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
Patent: COMPOSICIONES Y MÉTODOS PARA INHIBIR LA EXPRESIÓN DEL GEN SINTASA 1 DE ÁCIDO 5-AMINOLEVULÍNICO (ALAS1)
Estimated Expiration: ⤷  Sign Up

Patent: 8658
Patent: COMPOSICIONES Y MÉTODOS PARA INHIBIR LA EXPRESIÓN DEL GEN ALAS1
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 14331604
Patent: Compositions and methods for inhibiting expression of the ALAS1 gene
Estimated Expiration: ⤷  Sign Up

Patent: 20286311
Patent: Compositions and methods for inhibiting expression of the ALAS1 gene
Estimated Expiration: ⤷  Sign Up

Patent: 23266354
Patent: Compositions and methods for inhibiting expression of the ALAS1 gene
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2016007226
Patent: composições e métodos para inibição da expressão do gene alas1
Estimated Expiration: ⤷  Sign Up

Patent: 2020001264
Patent: ÁCIDO RIBONUCLEICO DE FITA DUPLA (DSRNA) PARA INIBIÇÃO DA EXPRESSÃO DE ALAS1, COMPOSIÇÃO FARMACÊUTICA PARA INIBIÇÃO DA EXPRESSÃO DE UM GENE ALAS1, MÉTODOS DE INIBIÇÃO DA EXPRESSÃO DE ALAS1 EM UMA CÉLULA E PARA DIMINUIR UM NÍVEL DE UMA PORFIRINA OU DE UM PRECURSOR DE PORFIRINA EM UMA CÉLULA, USOS DE UM DSRNA, MÉTODO PARA AVALIAR O NÍVEL DE MRNA DE ALAS1 EXTRACELULAR EM CIRCULAÇÃO EM UM INDIVÍDUO, COMPOSIÇÃO E USO DA MESMA
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 25357
Patent: COMPOSITIONS ET METHODES PERMETTANT D'INHIBER L'EXPRESSION DU GENE ALAS1 (COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE)
Estimated Expiration: ⤷  Sign Up

Patent: 27061
Patent: COMPOSITIONS ET METHODES PERMETTANT D'INHIBER L'EXPRESSION DU GENE ALAS1 (COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 16000772
Patent: Composiciones y métodos para inhibir la expresión del gen alas1
Estimated Expiration: ⤷  Sign Up

Patent: 18000158
Patent: Composiciones y métodos para inhibir la expresión del gen alas1 (divisional de solicitud 20160772)
Estimated Expiration: ⤷  Sign Up

China

Patent: 5980559
Patent: 用于抑制ALAS1基因表达的组合物与方法 (COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF ALAS1 GENE)
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 160195
Patent: COMPOSICIONES Y MÉTODOS PARA INHIBIR LA EXPRESIÓN DEL GEN ALAS 1
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0200822
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 22975
Estimated Expiration: ⤷  Sign Up

Patent: 20029
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 52628
Estimated Expiration: ⤷  Sign Up

Dominican Republic

Patent: 016000073
Patent: COMPOSICIONES Y MÉTODOS PARA INHIBIR LA EXPRESIÓN DEL GEN ALAS1
Estimated Expiration: ⤷  Sign Up

Patent: 022000085
Patent: COMPOSICIONES Y MÉTODOS PARA INHIBIR LA EXPRESIÓN DEL GEN ALAS1
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 6477
Patent: КОМПОЗИЦИИ И СПОСОБЫ ИНГИБИРОВАНИЯ ЭКСПРЕССИИ ГЕНА ALAS1 (COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE)
Estimated Expiration: ⤷  Sign Up

Patent: 1690685
Patent: КОМПОЗИЦИИ И СПОСОБЫ ИНГИБИРОВАНИЯ ЭКСПРЕССИИ ГЕНА ALAS1
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 52628
Patent: COMPOSITIONS ET MÉTHODES PERMETTANT D'INHIBER L'EXPRESSION DU GÈNE ALAS1 (COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE)
Estimated Expiration: ⤷  Sign Up

Patent: 93463
Patent: COMPOSITIONS ET PROCÉDÉS D'INHIBITION D'EXPRESSION DU GÈNE ALAS1 (COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE)
Estimated Expiration: ⤷  Sign Up

Guatemala

Patent: 1600066
Patent: COMPOSICIONES Y MÉTODOS PARA INHIBIR LA EXPRESIÓN DEL GEN ALAS1
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 21738
Patent: 抑制 基因表現的組合物及方法 (COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE ALAS1)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 49227
Estimated Expiration: ⤷  Sign Up

Patent: 000034
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 4749
Patent: תכשירים ושיטות לעיכוב ביטוי של גן ה alas1 (Compositions and methods for inhibiting expression of the alas1 gene)
Estimated Expiration: ⤷  Sign Up

Patent: 2747
Patent: תכשירים ושיטות לעיכוב ביטוי של גן ה alas1 (Compositions and methods for inhibiting expression of the alas1 gene)
Estimated Expiration: ⤷  Sign Up

Patent: 2726
Patent: תכשירים ושיטות לעיכוב ביטוי של גן ה alas1 (Compositions and methods for inhibiting expression of the alas1 gene)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 13227
Estimated Expiration: ⤷  Sign Up

Patent: 89254
Estimated Expiration: ⤷  Sign Up

Patent: 16539623
Patent: ALAS1遺伝子の発現を阻害する組成物および方法
Estimated Expiration: ⤷  Sign Up

Patent: 20096582
Patent: ALAS1遺伝子の発現を阻害する組成物および方法 (COMPOSITION AND METHOD FOR INHIBITING EXPRESSION OF ALAS1 GENE)
Estimated Expiration: ⤷  Sign Up

Patent: 23120219
Patent: ALAS1遺伝子の発現を阻害する組成物および方法 (COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 052628
Estimated Expiration: ⤷  Sign Up

Patent: 2020527
Estimated Expiration: ⤷  Sign Up

Patent: 52628
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 3490
Patent: COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE
Estimated Expiration: ⤷  Sign Up

Patent: 7646
Patent: COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 16004319
Patent: COMPOSICIONES Y METODOS PARA INHIBIR LA EXPRESION DEL GEN DE SINTASA DE ACIDO 5'-AMINOLEVULINICO 1 (ALAS1). (COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE.)
Estimated Expiration: ⤷  Sign Up

Patent: 22001017
Patent: COMPOSICIONES Y METODOS PARA INHIBIR LA EXPRESION DEL GEN DE SINTASA DE ACIDO 5'-AMINOLEVULINICO 1 (ALAS1). (COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE.)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 000
Patent: Compositions et méthodes permettant d'inhiber l'expression du gène alas1
Estimated Expiration: ⤷  Sign Up

Netherlands

Patent: 1061
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 8995
Patent: Compositions and methods for inhibiting expression of the alas1 gene
Estimated Expiration: ⤷  Sign Up

Patent: 7749
Patent: Compositions and methods for inhibiting expression of the alas1 gene
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 161130
Patent: COMPOSICIONES Y METODOS PARA INHIBIR LA EXPRESION DEL GEN ALAS1
Estimated Expiration: ⤷  Sign Up

Patent: 211249
Patent: PRODUCTO DE FARMACO DE siARN PARA INHIBIR LA EXPRESION DE ALAS1 Y COMPOSICION QUE LO COMPRENDE
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 016500574
Patent: COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 52628
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 52628
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201910929Q
Patent: COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE
Estimated Expiration: ⤷  Sign Up

Patent: 201602631X
Patent: COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 52628
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1602931
Patent: COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE
Estimated Expiration: ⤷  Sign Up

Patent: 1802919
Patent: COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 2307389
Estimated Expiration: ⤷  Sign Up

Patent: 2469850
Estimated Expiration: ⤷  Sign Up

Patent: 160079793
Patent: ALAS1 유전자의 발현을 억제하기 위한 조성물 및 방법 (COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE)
Estimated Expiration: ⤷  Sign Up

Patent: 210122877
Patent: ALAS1 유전자의 발현을 억제하기 위한 조성물 및 방법 (1 COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE)
Estimated Expiration: ⤷  Sign Up

Patent: 220159478
Patent: ALAS1 유전자의 발현을 억제하기 위한 조성물 및 방법 (1 COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 04510
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 94080
Estimated Expiration: ⤷  Sign Up

Patent: 68330
Estimated Expiration: ⤷  Sign Up

Patent: 1524991
Patent: Compositions and methods for inhibiting expression of the ALAS1 gene
Estimated Expiration: ⤷  Sign Up

Patent: 2106697
Patent: Compositions and methods for inhibiting expression of the ALAS1 gene
Estimated Expiration: ⤷  Sign Up

Patent: 2310853
Patent: Compositions and methods for inhibiting expression of the ALAS1 gene
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 16000114
Patent: COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE.
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 4961
Patent: ДВОНИТКОВА РИБОНУКЛЕЇНОВА КИСЛОТА (dsRNA) ДЛЯ ІНГІБУВАННЯ ЕКСПРЕСІЇ ALAS1 (COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE)
Estimated Expiration: ⤷  Sign Up

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
World Intellectual Property Organization (WIPO) 02055693 ⤷  Sign Up
Germany 19956568 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2009073809 ⤷  Sign Up
Cyprus 1119491 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2006032041 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for GIVLAARI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3052628 2020029 Norway ⤷  Sign Up PRODUCT NAME: GIVOSIRAN ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV; REG. NO/DATE: EU/1/20/1428 20200306
3052628 724 Finland ⤷  Sign Up
3052628 LUC00175 Luxembourg ⤷  Sign Up PRODUCT NAME: GIVOSIRAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1428 20200304
3052628 CA 2020 00042 Denmark ⤷  Sign Up PRODUCT NAME: GIVOSIRAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/20/1428 20200304
3052628 122020000045 Germany ⤷  Sign Up PRODUCT NAME: GIVOSIRAN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1428 20200302
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.