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 fourteen patents protecting this drug.
This drug has two hundred and forty-seven patent family members in thirty-one countries.
The generic ingredient in ONPATTRO is patisiran sodium. One supplier is listed for this compound. Additional details are available on the patisiran sodium profile page.
DrugPatentWatch® Generic Entry Outlook for Onpattro
Onpattro was eligible for patent challenges on August 10, 2022.
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 have been four patent litigation cases 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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Questions you can ask:
- What is the 5 year forecast for ONPATTRO?
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Summary for ONPATTRO
International Patents: | 247 |
US Patents: | 14 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 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 Loss of Exclusivity (LOE) 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 |
---|---|
Austin Neuromuscular Center | Early Phase 1 |
Alnylam Pharmaceuticals | Early Phase 1 |
Pharmacology for ONPATTRO
Drug Class | Small Interfering RNA Transthyretin-directed RNA Interaction |
Physiological Effect | Decreased RNA Integrity Increased Protein Breakdown |
US Patents and Regulatory Information for ONPATTRO
ONPATTRO is protected by fourteen US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ONPATTRO is ⤷ Subscribe.
This potential generic entry date is based on patent 8,158,601.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | 8,802,644 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | RX | Yes | Yes | 8,741,866 | ⤷ Subscribe | ⤷ Subscribe | ||||
Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | RX | Yes | Yes | 8,168,775 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | RX | Yes | Yes | 8,492,359 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | RX | Yes | Yes | 11,079,379 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | RX | Yes | Yes | 8,334,373 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
>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
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
Patent: Improved lipid formulation
Estimated Expiration: ⤷ Subscribe
Patent: 17202702
Patent: Improved lipid formulation
Estimated Expiration: ⤷ Subscribe
Patent: 19204984
Patent: Improved lipid formulation
Estimated Expiration: ⤷ Subscribe
Patent: 21201228
Patent: Improved lipid formulation
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 64609
Patent: FORMULATION LIPIDIQUE AMELIOREE (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Subscribe
Patent: 14827
Patent: LIPIDE CATIONIQUE AMELIORE DE FORMULE I (IMPROVED CATIONIC LIPID OF FORMULA I)
Estimated Expiration: ⤷ Subscribe
China
Patent: 2625696
Patent: Improved lipid formulation
Estimated Expiration: ⤷ Subscribe
Patent: 4873464
Patent: Improved lipid formulation
Estimated Expiration: ⤷ Subscribe
Croatia
Patent: 0181221
Estimated Expiration: ⤷ Subscribe
Patent: 0211619
Estimated Expiration: ⤷ Subscribe
Cyprus
Patent: 20641
Estimated Expiration: ⤷ Subscribe
Patent: 24769
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 40183
Estimated Expiration: ⤷ Subscribe
Patent: 31076
Estimated Expiration: ⤷ Subscribe
Eurasian Patent Organization
Patent: 4960
Patent: УЛУЧШЕННАЯ ЛИПИДНАЯ КОМПОЗИЦИЯ (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Subscribe
Patent: 8860
Patent: УЛУЧШЕННАЯ ЛИПИДНАЯ КОМПОЗИЦИЯ (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Subscribe
Patent: 1190306
Patent: УЛУЧШЕННАЯ ЛИПИДНАЯ КОМПОЗИЦИЯ
Estimated Expiration: ⤷ Subscribe
Patent: 1690312
Patent: УЛУЧШЕННАЯ ЛИПИДНАЯ КОМПОЗИЦИЯ
Estimated Expiration: ⤷ Subscribe
Patent: 1791744
Patent: УЛУЧШЕННАЯ ЛИПИДНАЯ КОМПОЗИЦИЯ
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 40183
Patent: FORMULATION LIPIDIQUE AMÉLIORÉE (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Subscribe
Patent: 31076
Patent: FORMULATION LIPIDIQUE AMÉLIORÉE (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Subscribe
Hong Kong
Patent: 12620
Patent: 改進的脂質製劑 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Subscribe
Hungary
Patent: 38796
Estimated Expiration: ⤷ Subscribe
Patent: 56773
Estimated Expiration: ⤷ Subscribe
Israel
Patent: 6876
Patent: ליפיד קטיוני, פורמולציות ליפידיות הכוללות אותו ושימושן בהכנת גורמים טיפוליים למתן לתאים (Cationic lipid, lipid formulations comprising same and use thereof in the preparation of therapeutic agents for delivering to cells)
Estimated Expiration: ⤷ Subscribe
Patent: 4945
Patent: ליפיד קטיוני, פורמולציות ליפידיות הכוללות אותו ושימושן בהכנת גורמים טיפוליים למתן לתאים (Cationic lipid, lipid formulations comprising same and use thereof in the preparation of therapeutic agents for delivering to cells)
Estimated Expiration: ⤷ Subscribe
Patent: 4826
Patent: פורמולציה ליפידית משופרת (Improved lipid formulation)
Estimated Expiration: ⤷ Subscribe
Patent: 0077
Patent: פורמולציה ליפידית משופרת (Improved lipid formulation)
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 19291
Estimated Expiration: ⤷ Subscribe
Patent: 32321
Estimated Expiration: ⤷ Subscribe
Patent: 59719
Estimated Expiration: ⤷ Subscribe
Patent: 92144
Estimated Expiration: ⤷ Subscribe
Patent: 12530059
Estimated Expiration: ⤷ Subscribe
Patent: 15232048
Patent: 改善された脂質製剤 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Subscribe
Patent: 17122126
Patent: 改善された脂質製剤 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Subscribe
Patent: 18141019
Patent: 改善された脂質製剤 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Subscribe
Lithuania
Patent: 40183
Estimated Expiration: ⤷ Subscribe
Patent: 31076
Estimated Expiration: ⤷ Subscribe
Mexico
Patent: 2785
Patent: FORMULACION MEJORADA DE LIPIDO. (IMPROVED LIPID FORMULATION.)
Estimated Expiration: ⤷ Subscribe
Patent: 7665
Patent: FORMULACIÓN MEJORADA DE LÍPIDO. (IMPROVED LIPID FORMULATION.)
Estimated Expiration: ⤷ Subscribe
Patent: 11013320
Patent: FORMULACION MEJORADA DE LIPIDO. (IMPROVED LIPID FORMULATION.)
Estimated Expiration: ⤷ Subscribe
Patent: 19010340
Patent: FORMULACION MEJORADA DE LIPIDO. (IMPROVED LIPID FORMULATION.)
Estimated Expiration: ⤷ Subscribe
New Zealand
Patent: 6958
Patent: Improved lipid formulation
Estimated Expiration: ⤷ Subscribe
Patent: 2843
Patent: Improved lipid formulation
Estimated Expiration: ⤷ Subscribe
Patent: 2719
Patent: Improved lipid formulation
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 40183
Estimated Expiration: ⤷ Subscribe
Patent: 31076
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 40183
Estimated Expiration: ⤷ Subscribe
Patent: 31076
Estimated Expiration: ⤷ Subscribe
Singapore
Patent: 6786
Patent: IMPROVED LIPID FORMULATION
Estimated Expiration: ⤷ Subscribe
Patent: 201403054S
Patent: IMPROVED LIPID FORMULATION
Estimated Expiration: ⤷ Subscribe
Patent: 201912450X
Patent: IMPROVED LIPID FORMULATION
Estimated Expiration: ⤷ Subscribe
Slovenia
Patent: 40183
Estimated Expiration: ⤷ Subscribe
Patent: 31076
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 1766408
Estimated Expiration: ⤷ Subscribe
Patent: 1987962
Estimated Expiration: ⤷ Subscribe
Patent: 2066189
Estimated Expiration: ⤷ Subscribe
Patent: 2205886
Estimated Expiration: ⤷ Subscribe
Patent: 2374518
Estimated Expiration: ⤷ Subscribe
Patent: 120081065
Patent: IMPROVED LIPID FORMULATION
Estimated Expiration: ⤷ Subscribe
Patent: 170091798
Patent: 향상된 지질 조성물 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Subscribe
Patent: 190065474
Patent: 향상된 지질 조성물 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Subscribe
Patent: 200006176
Patent: 향상된 지질 조성물 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Subscribe
Patent: 210008938
Patent: 향상된 지질 조성물 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Subscribe
Patent: 220038506
Patent: 향상된 지질 조성물 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Subscribe
Patent: 230098713
Patent: 향상된 지질 조성물 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 89168
Estimated Expiration: ⤷ Subscribe
Patent: 01627
Estimated Expiration: ⤷ Subscribe
Turkey
Patent: 1811076
Estimated Expiration: ⤷ Subscribe
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 |
---|---|---|---|
Russian Federation | 2007131270 | ⤷ Subscribe | |
Lithuania | C2937418 | ⤷ Subscribe | |
Australia | 2009222605 | 4'-Thionucleosides and oligomeric compounds | ⤷ Subscribe |
Austria | 373724 | ⤷ Subscribe | |
Australia | 2003290573 | CROSS-LINKED OLIGOMERIC COMPOUNDS AND THEIR USE IN GENE MODULATION | ⤷ Subscribe |
World Intellectual Property Organization (WIPO) | 2005121370 | ⤷ Subscribe | |
Japan | 5697988 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ONPATTRO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2937418 | LUC00098 | Luxembourg | ⤷ Subscribe | PRODUCT NAME: PATISIRAN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (ONPATTRO ); AUTHORISATION NUMBER AND DATE: EU/1/18/1320 20180829 |
1407044 | 132019000000031 | Italy | ⤷ Subscribe | PRODUCT NAME: PATISIRAN(ONPATTRO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1320, 20180829 |
2937418 | 682 | Finland | ⤷ Subscribe | |
2937418 | C201930007 | Spain | ⤷ Subscribe | PRODUCT NAME: PATISIRAN; NATIONAL AUTHORISATION NUMBER: EU/1/18/1320; DATE OF AUTHORISATION: 20180827; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1320; DATE OF FIRST AUTHORISATION IN EEA: 20180827 |
2937418 | 300965 | Netherlands | ⤷ Subscribe | PRODUCT NAME: PATISIRAN; REGISTRATION NO/DATE: EU/1/18/1320 20180829 |
2937418 | PA2019501 | Lithuania | ⤷ Subscribe | PRODUCT NAME: PATISIRANAS; REGISTRATION NO/DATE: EU/1/18/1320 20180827 |
2937418 | 19C1002 | France | ⤷ Subscribe | PRODUCT NAME: PATISIRAN; REGISTRATION NO/DATE: EU/1/18/1320 20180829 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
ONPATTRO Market Analysis and Financial Projection Experimental
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