PATISIRAN SODIUM - Generic Drug Details
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What are the generic drug sources for patisiran sodium and what is the scope of freedom to operate?
Patisiran sodium
is the generic ingredient in one branded drug marketed by Alnylam Pharms Inc and is included in one NDA. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Patisiran sodium has two hundred and forty-seven patent family members in thirty-one countries.
One supplier is listed for this compound.
Summary for PATISIRAN SODIUM
International Patents: | 247 |
US Patents: | 14 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PATISIRAN SODIUM |
DailyMed Link: | PATISIRAN SODIUM at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PATISIRAN SODIUM
Generic Entry Date for PATISIRAN SODIUM*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for PATISIRAN SODIUM
Drug Class | Small Interfering RNA Transthyretin-directed RNA Interaction |
Physiological Effect | Decreased RNA Integrity Increased Protein Breakdown |
Anatomical Therapeutic Chemical (ATC) Classes for PATISIRAN SODIUM
US Patents and Regulatory Information for PATISIRAN SODIUM
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 | 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 | ⤷ 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 | 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 | |||
>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 PATISIRAN SODIUM
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 |
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 PATISIRAN SODIUM
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Norway | 2019004 | ⤷ Sign Up | |
Canada | 2739895 | COMPOSITIONS ET PROCEDES POUR INHIBER L'EXPRESSION DE LA TRANSTHYRETINE (COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF TRANSTHYRETIN) | ⤷ Sign Up |
Japan | 2017036330 | 製剤用化合物 (COMPOUND FOR PREPARATION) | ⤷ Sign Up |
Japan | 2015232048 | 改善された脂質製剤 (IMPROVED LIPID FORMULATION) | ⤷ Sign Up |
South Korea | 20220038506 | 향상된 지질 조성물 (IMPROVED LIPID FORMULATION) | ⤷ Sign Up |
Hong Kong | 1156348 | 抑制運甲狀腺素蛋白表達的組合物和方法 (COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF TRANSTHYRETIN) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PATISIRAN SODIUM
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2937418 | C201930007 | Spain | ⤷ Sign Up | 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 | 2019/004 | Ireland | ⤷ Sign Up | PRODUCT NAME: PATISIRAN; REGISTRATION NO/DATE: EU/1/18/1320 20180827 |
2937418 | 3/2019 | Austria | ⤷ Sign Up | PRODUCT NAME: PATISIRAN; REGISTRATION NO/DATE: EU/1/18/1320 (MITTEILUNG) 20180829 |
2937418 | 1990004-2 | Sweden | ⤷ Sign Up | PRODUCT NAME: PATISIRAN; REG. NO/DATE: EU/1/18/1320 20180829 |
2937418 | 2019C/501 | Belgium | ⤷ Sign Up | PRODUCT NAME: PATISIRAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1320 20180829 |
2937418 | CR 2019 00005 | Denmark | ⤷ Sign Up | PRODUCT NAME: PATISIRAN; REG. NO/DATE: EU/1/18/1320 20180829 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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