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Last Updated: May 26, 2022

ONPATTRO Drug Patent Profile


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

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

This drug has three hundred and thirteen patent family members in thirty-three countries.

The generic ingredient in ONPATTRO is patisiran sodium. Additional details are available on the patisiran sodium profile page.

DrugPatentWatch® Generic Entry Outlook for Onpattro

Onpattro will be eligible for patent challenges on August 10, 2022. 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 November 10, 2030. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for ONPATTRO
International Patents:313
US Patents:16
Applicants:1
NDAs:1
Clinical Trials: 1
Drug Prices: Drug price information for ONPATTRO
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for ONPATTRO
What excipients (inactive ingredients) are in ONPATTRO?ONPATTRO excipients list
DailyMed Link:ONPATTRO at DailyMed
Drug patent expirations by year for ONPATTRO
Drug Prices for ONPATTRO

See drug prices for ONPATTRO

DrugPatentWatch® Estimated Generic Entry Opportunity Date for ONPATTRO
Generic Entry Date for ONPATTRO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS

*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 ONPATTRO

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

SponsorPhase
Alnylam PharmaceuticalsEarly Phase 1
Austin Neuromuscular CenterEarly Phase 1

See all ONPATTRO clinical trials

US Patents and Regulatory Information for ONPATTRO

ONPATTRO is protected by sixteen US patents and two FDA Regulatory Exclusivities.

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

Compositions and methods for inhibiting expression of transthyretin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS

Methods of treating transthyretin (TTR) mediated amyloidosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS

Lipid formulations for nucleic acid delivery
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Lipid formulations for nucleic acid delivery
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Lipid formulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS

Compositions and methods for inhibiting expression of transthyretin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS

Nuclease resistant double-stranded ribonucleic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Lipid formulations for nucleic acid delivery
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Lipid containing formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and methods for inhibiting expression of transthyretin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS

Lipid formulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS

Lipid formulations for nucleic acid delivery
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS

Compositions and methods for inhibiting expression of transthyretin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS

Lipid formulations for nucleic acid delivery
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS

2'-methoxy substituted oligomeric compounds and compositions for use in gene modulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

2'-methoxy substituted oligomeric compounds and compositions for use in gene modulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting ONPATTRO

INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
Exclusivity Expiration: See Plans and Pricing

NEW CHEMICAL ENTITY
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 ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 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

Expired US Patents for ONPATTRO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 See Plans and Pricing See Plans and Pricing
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 See Plans and Pricing See Plans and Pricing
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 See Plans and Pricing See Plans and Pricing
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 See Plans and Pricing See Plans and Pricing
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 See Plans and Pricing See Plans and Pricing
Alnylam Pharms Inc ONPATTRO patisiran sodium SOLUTION;INTRAVENOUS 210922-001 Aug 10, 2018 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ONPATTRO

When does loss-of-exclusivity occur for ONPATTRO?

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

Australia

Patent: 10259984
Estimated Expiration: See Plans and Pricing

Patent: 17202702
Estimated Expiration: See Plans and Pricing

Patent: 19204984
Estimated Expiration: See Plans and Pricing

Patent: 21201228
Estimated Expiration: See Plans and Pricing

Canada

Patent: 64609
Estimated Expiration: See Plans and Pricing

Patent: 14827
Estimated Expiration: See Plans and Pricing

China

Patent: 2625696
Estimated Expiration: See Plans and Pricing

Patent: 4873464
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0181221
Estimated Expiration: See Plans and Pricing

Patent: 0211619
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 20641
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 40183
Estimated Expiration: See Plans and Pricing

Patent: 31076
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 4960
Estimated Expiration: See Plans and Pricing

Patent: 8860
Estimated Expiration: See Plans and Pricing

Patent: 1190306
Estimated Expiration: See Plans and Pricing

Patent: 1690312
Estimated Expiration: See Plans and Pricing

Patent: 1791744
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 40183
Estimated Expiration: See Plans and Pricing

Patent: 31076
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 12620
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 38796
Estimated Expiration: See Plans and Pricing

Patent: 56773
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6876
Estimated Expiration: See Plans and Pricing

Patent: 4945
Estimated Expiration: See Plans and Pricing

Patent: 4826
Estimated Expiration: See Plans and Pricing

Patent: 0077
Estimated Expiration: See Plans and Pricing

Japan

Patent: 19291
Estimated Expiration: See Plans and Pricing

Patent: 32321
Estimated Expiration: See Plans and Pricing

Patent: 59719
Estimated Expiration: See Plans and Pricing

Patent: 92144
Estimated Expiration: See Plans and Pricing

Patent: 12530059
Estimated Expiration: See Plans and Pricing

Patent: 15232048
Estimated Expiration: See Plans and Pricing

Patent: 17122126
Estimated Expiration: See Plans and Pricing

Patent: 18141019
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 40183
Estimated Expiration: See Plans and Pricing

Patent: 31076
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 2785
Estimated Expiration: See Plans and Pricing

Patent: 7665
Estimated Expiration: See Plans and Pricing

Patent: 11013320
Estimated Expiration: See Plans and Pricing

Patent: 19010340
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 6958
Estimated Expiration: See Plans and Pricing

Patent: 2843
Estimated Expiration: See Plans and Pricing

Patent: 2719
Estimated Expiration: See Plans and Pricing

Poland

Patent: 40183
Estimated Expiration: See Plans and Pricing

Patent: 31076
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 40183
Estimated Expiration: See Plans and Pricing

Patent: 31076
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 6786
Estimated Expiration: See Plans and Pricing

Patent: 201403054S
Estimated Expiration: See Plans and Pricing

Patent: 201912450X
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 40183
Estimated Expiration: See Plans and Pricing

Patent: 31076
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1766408
Estimated Expiration: See Plans and Pricing

Patent: 1987962
Estimated Expiration: See Plans and Pricing

Patent: 2066189
Estimated Expiration: See Plans and Pricing

Patent: 2205886
Estimated Expiration: See Plans and Pricing

Patent: 2374518
Estimated Expiration: See Plans and Pricing

Patent: 120081065
Estimated Expiration: See Plans and Pricing

Patent: 170091798
Estimated Expiration: See Plans and Pricing

Patent: 190065474
Estimated Expiration: See Plans and Pricing

Patent: 200006176
Estimated Expiration: See Plans and Pricing

Patent: 210008938
Estimated Expiration: See Plans and Pricing

Patent: 220038506
Estimated Expiration: See Plans and Pricing

Spain

Patent: 89168
Estimated Expiration: See Plans and Pricing

Patent: 01627
Estimated Expiration: See Plans and Pricing

Turkey

Patent: 1811076
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 ONPATTRO around the world.

Country Patent Number Title Estimated Expiration
South Korea 20220038506 향상된 지질 조성물 (IMPROVED LIPID FORMULATION) See Plans and Pricing
Eurasian Patent Organization 201400170 КОМПОЗИЦИИ И СПОСОБЫ ДЛЯ ИНГИБИРОВАНИЯ ЭКСПРЕССИИ ТРАНСТИРЕТИНА See Plans and Pricing
New Zealand 525888 RNA interference mediating small RNA molecules See Plans and Pricing
Russian Federation 2470073 МАЛЫЕ МОЛЕКУЛЫ РНК, ОПОСРЕДУЮЩИЕ ИНТЕРФЕРЕНЦИЮ РНК (SMALL RNA MOLECULES, MEDIATING RNA INTERFERENCE) See Plans and Pricing
Cyprus 1115228 See Plans and Pricing
Canada 2504554 COMPOSES OLIGOMERES 2'-SUBSTITUES ET COMPOSITIONS DESTINEES A ETRE UTILISEES DANS DES MODULATIONS GENETIQUES (2'-SUBSTITUTED OLIGOMERIC COMPOUNDS AND COMPOSITIONS FOR USEIN GENE MODULATIONS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ONPATTRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2937418 2019004 Norway See Plans and Pricing PRODUCT NAME: PATISIRAN: DEKKET GJENNOM SEKVENSENE I KRAVENE 1, 8 OG 9 (SE SAERLIG KRAV 8 (B) OG (C) I PATENTET. DET VISES OGSA TIL FOELGEBREVET TIL SOEKNADEN.; REG. NO/DATE: EU/1/18/1320 20180911
2937418 2019C/501 Belgium See Plans and Pricing PRODUCT NAME: PATISIRAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1320 20180829
2937418 C02937418/01 Switzerland See Plans and Pricing PRODUCT NAME: PATISIRAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67304 23.09.2019
2937418 C20190005 00300 Estonia See Plans and Pricing PRODUCT NAME: PATISIRAAN;REG NO/DATE: EU/1/18/1320 29.08.2018
2937418 CR 2019 00005 Denmark See Plans and Pricing PRODUCT NAME: PATISIRAN; REG. NO/DATE: EU/1/18/1320 20180829
2937418 3/2019 Austria See Plans and Pricing PRODUCT NAME: PATISIRAN; REGISTRATION NO/DATE: EU/1/18/1320 (MITTEILUNG) 20180829
>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.