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
AI Research Assistant
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
*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 |
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 ⤷ 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 ONPATTRO
Compositions and methods for inhibiting expression of transthyretin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
Methods of treating transthyretin (TTR) mediated amyloidosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
Lipid formulations for nucleic acid delivery
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Lipid formulations for nucleic acid delivery
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Lipid formulation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
Compositions and methods for inhibiting expression of transthyretin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
Nuclease resistant double-stranded ribonucleic acid
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Lipid formulations for nucleic acid delivery
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Lipid containing formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compositions and methods for inhibiting expression of transthyretin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
Lipid formulation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
Lipid formulations for nucleic acid delivery
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
Compositions and methods for inhibiting expression of transthyretin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
Lipid formulations for nucleic acid delivery
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS
FDA Regulatory Exclusivity protecting ONPATTRO
INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
Exclusivity Expiration: ⤷ Sign Up
INFORMATION ADDED TO CLINICAL PHARMACOLOGY SECTION
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 | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | 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 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 | ⤷ Sign Up | ⤷ Sign Up |
| Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | ⤷ Sign Up | ⤷ Sign Up |
| Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | ⤷ Sign Up | ⤷ Sign Up |
| Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | ⤷ Sign Up | ⤷ Sign Up |
| Alnylam Pharms Inc | ONPATTRO | patisiran sodium | SOLUTION;INTRAVENOUS | 210922-001 | Aug 10, 2018 | ⤷ Sign Up | ⤷ Sign Up |
| >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
Patent: Improved lipid formulation
Estimated Expiration: ⤷ Sign Up
Patent: 17202702
Patent: Improved lipid formulation
Estimated Expiration: ⤷ Sign Up
Patent: 19204984
Patent: Improved lipid formulation
Estimated Expiration: ⤷ Sign Up
Patent: 21201228
Patent: Improved lipid formulation
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 64609
Patent: FORMULATION LIPIDIQUE AMELIOREE (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Sign Up
Patent: 14827
Patent: LIPIDE CATIONIQUE AMELIORE DE FORMULE I (IMPROVED CATIONIC LIPID OF FORMULA I)
Estimated Expiration: ⤷ Sign Up
China
Patent: 2625696
Patent: Improved lipid formulation
Estimated Expiration: ⤷ Sign Up
Patent: 4873464
Patent: Improved lipid formulation
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0181221
Estimated Expiration: ⤷ Sign Up
Patent: 0211619
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 20641
Estimated Expiration: ⤷ Sign Up
Patent: 24769
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 40183
Estimated Expiration: ⤷ Sign Up
Patent: 31076
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 4960
Patent: УЛУЧШЕННАЯ ЛИПИДНАЯ КОМПОЗИЦИЯ (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Sign Up
Patent: 8860
Patent: УЛУЧШЕННАЯ ЛИПИДНАЯ КОМПОЗИЦИЯ (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Sign Up
Patent: 1190306
Patent: УЛУЧШЕННАЯ ЛИПИДНАЯ КОМПОЗИЦИЯ
Estimated Expiration: ⤷ Sign Up
Patent: 1690312
Patent: УЛУЧШЕННАЯ ЛИПИДНАЯ КОМПОЗИЦИЯ
Estimated Expiration: ⤷ Sign Up
Patent: 1791744
Patent: УЛУЧШЕННАЯ ЛИПИДНАЯ КОМПОЗИЦИЯ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 40183
Patent: FORMULATION LIPIDIQUE AMÉLIORÉE (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Sign Up
Patent: 31076
Patent: FORMULATION LIPIDIQUE AMÉLIORÉE (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 12620
Patent: 改進的脂質製劑 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 38796
Estimated Expiration: ⤷ Sign Up
Patent: 56773
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
Patent: 4826
Patent: פורמולציה ליפידית משופרת (Improved lipid formulation)
Estimated Expiration: ⤷ Sign Up
Patent: 0077
Patent: פורמולציה ליפידית משופרת (Improved lipid formulation)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 19291
Estimated Expiration: ⤷ Sign Up
Patent: 32321
Estimated Expiration: ⤷ Sign Up
Patent: 59719
Estimated Expiration: ⤷ Sign Up
Patent: 92144
Estimated Expiration: ⤷ Sign Up
Patent: 12530059
Estimated Expiration: ⤷ Sign Up
Patent: 15232048
Patent: 改善された脂質製剤 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Sign Up
Patent: 17122126
Patent: 改善された脂質製剤 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Sign Up
Patent: 18141019
Patent: 改善された脂質製剤 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 40183
Estimated Expiration: ⤷ Sign Up
Patent: 31076
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 2785
Patent: FORMULACION MEJORADA DE LIPIDO. (IMPROVED LIPID FORMULATION.)
Estimated Expiration: ⤷ Sign Up
Patent: 7665
Patent: FORMULACIÓN MEJORADA DE LÍPIDO. (IMPROVED LIPID FORMULATION.)
Estimated Expiration: ⤷ Sign Up
Patent: 11013320
Patent: FORMULACION MEJORADA DE LIPIDO. (IMPROVED LIPID FORMULATION.)
Estimated Expiration: ⤷ Sign Up
Patent: 19010340
Patent: FORMULACION MEJORADA DE LIPIDO. (IMPROVED LIPID FORMULATION.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 6958
Patent: Improved lipid formulation
Estimated Expiration: ⤷ Sign Up
Patent: 2843
Patent: Improved lipid formulation
Estimated Expiration: ⤷ Sign Up
Patent: 2719
Patent: Improved lipid formulation
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 40183
Estimated Expiration: ⤷ Sign Up
Patent: 31076
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 40183
Estimated Expiration: ⤷ Sign Up
Patent: 31076
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 6786
Patent: IMPROVED LIPID FORMULATION
Estimated Expiration: ⤷ Sign Up
Patent: 201403054S
Patent: IMPROVED LIPID FORMULATION
Estimated Expiration: ⤷ Sign Up
Patent: 201912450X
Patent: IMPROVED LIPID FORMULATION
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 40183
Estimated Expiration: ⤷ Sign Up
Patent: 31076
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1766408
Estimated Expiration: ⤷ Sign Up
Patent: 1987962
Estimated Expiration: ⤷ Sign Up
Patent: 2066189
Estimated Expiration: ⤷ Sign Up
Patent: 2205886
Estimated Expiration: ⤷ Sign Up
Patent: 2374518
Estimated Expiration: ⤷ Sign Up
Patent: 120081065
Patent: IMPROVED LIPID FORMULATION
Estimated Expiration: ⤷ Sign Up
Patent: 170091798
Patent: 향상된 지질 조성물 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Sign Up
Patent: 190065474
Patent: 향상된 지질 조성물 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Sign Up
Patent: 200006176
Patent: 향상된 지질 조성물 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Sign Up
Patent: 210008938
Patent: 향상된 지질 조성물 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Sign Up
Patent: 220038506
Patent: 향상된 지질 조성물 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Sign Up
Patent: 230098713
Patent: 향상된 지질 조성물 (IMPROVED LIPID FORMULATION)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 89168
Estimated Expiration: ⤷ Sign Up
Patent: 01627
Estimated Expiration: ⤷ Sign Up
Turkey
Patent: 1811076
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 ONPATTRO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2461715 | ⤷ Sign Up | |
| New Zealand | 588583 | NOVEL LIPID FORMULATIONS FOR NUCLEIC ACID DELIVERY | ⤷ Sign Up |
| Japan | 2017036330 | 製剤用化合物 (COMPOUND FOR PREPARATION) | ⤷ Sign Up |
| Singapore | 10201809460S | COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF TRANSTHYRETIN | ⤷ Sign Up |
| Australia | 2021201228 | Improved lipid formulation | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ONPATTRO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2937418 | CA 2019 00005 | Denmark | ⤷ Sign Up | PRODUCT NAME: PATISIRAN... (NAVN FOR LANGT); REG. NO/DATE: EU/1/18/1320 20180829 |
| 2937418 | PA2019501,C2937418 | Lithuania | ⤷ Sign Up | PRODUCT NAME: PATISIRANAS; REGISTRATION NO/DATE: EU/1/18/1320 20180827 |
| 2937418 | CR 2019 00005 | Denmark | ⤷ Sign Up | PRODUCT NAME: PATISIRAN; REG. NO/DATE: EU/1/18/1320 20180829 |
| 1407044 | 132019000000031 | Italy | ⤷ Sign Up | PRODUCT NAME: PATISIRAN(ONPATTRO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1320, 20180829 |
| 2937418 | PA2019501 | Lithuania | ⤷ Sign Up | PRODUCT NAME: PATISIRANAS; REGISTRATION NO/DATE: EU/1/18/1320 20180827 |
| >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.
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