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
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 |


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
Sponsor | Phase |
---|---|
Alnylam Pharmaceuticals | Early Phase 1 |
Austin Neuromuscular Center | Early Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for ONPATTRO
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
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 |