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-five patent family members in thirty-one countries.
One supplier is listed for this compound.
Summary for PATISIRAN SODIUM
| International Patents: | 245 |
| 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
*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 | ⤷ 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 | ⤷ 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 | ⤷ 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 |
|---|---|---|---|
| Spain | 2928500 | ⤷ Sign Up | |
| Hungary | E026604 | ⤷ Sign Up | |
| Japan | 2013213036 | ASSOCIATION COMPLEX AND METHOD OF FORMING THE SAME | ⤷ Sign Up |
| Mexico | 2019010340 | FORMULACION MEJORADA DE LIPIDO. (IMPROVED LIPID FORMULATION.) | ⤷ Sign Up |
| Canada | 2721333 | NOUVELLES FORMULATIONS LIPIDIQUES POUR L'ADMINISTRATION D'ACIDES NUCLEIQUES (NOVEL LIPID FORMULATIONS FOR NUCLEIC ACID DELIVERY) | ⤷ Sign Up |
| Eurasian Patent Organization | 201170591 | КОМПОЗИЦИИ И СПОСОБЫ ДЛЯ ИНГИБИРОВАНИЯ ЭКСПРЕССИИ ТРАНСТИРЕТИНА | ⤷ 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 | 300965 | Netherlands | ⤷ Sign Up | PRODUCT NAME: PATISIRAN; REGISTRATION NO/DATE: EU/1/18/1320 20180829 |
| 2937418 | CR 2019 00005 | Denmark | ⤷ Sign Up | PRODUCT NAME: PATISIRAN; REG. NO/DATE: EU/1/18/1320 20180829 |
| 2937418 | 2019004 | Norway | ⤷ Sign Up | 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 | CA 2019 00005 | Denmark | ⤷ Sign Up | PRODUCT NAME: PATISIRAN... (NAVN FOR LANGT); REG. NO/DATE: EU/1/18/1320 20180829 |
| 2937418 | 3/2019 | Austria | ⤷ Sign Up | PRODUCT NAME: PATISIRAN; REGISTRATION NO/DATE: EU/1/18/1320 (MITTEILUNG) 20180829 |
| 2937418 | 682 | Finland | ⤷ Sign Up | |
| >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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