Lumasiran sodium - Generic Drug Details
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What are the generic sources for lumasiran sodium and what is the scope of patent protection?
Lumasiran 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.Lumasiran sodium has one hundred and sixty-seven patent family members in forty-two countries.
One supplier is listed for this compound.
Summary for lumasiran sodium
| International Patents: | 167 |
| US Patents: | 14 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| DailyMed Link: | lumasiran sodium at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for lumasiran sodium
Generic Entry Date for lumasiran sodium*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS |
*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.
Anatomical Therapeutic Chemical (ATC) Classes for lumasiran sodium
US Patents and Regulatory Information for lumasiran 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 | OXLUMO | lumasiran sodium | SOLUTION;SUBCUTANEOUS | 214103-001 | Nov 23, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Alnylam Pharms Inc | OXLUMO | lumasiran sodium | SOLUTION;SUBCUTANEOUS | 214103-001 | Nov 23, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Alnylam Pharms Inc | OXLUMO | lumasiran sodium | SOLUTION;SUBCUTANEOUS | 214103-001 | Nov 23, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Alnylam Pharms Inc | OXLUMO | lumasiran sodium | SOLUTION;SUBCUTANEOUS | 214103-001 | Nov 23, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for lumasiran sodium
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Lithuania | PA2022004 | ⤷ Try a Trial | |
| Canada | 2935220 | PROCEDE ET COMPOSITION POUR L'INHIBITION SPECIFIQUE DE LA GLYCOLATE OXYDASE (HAO1) PAR UN ARN BICATENAIRE (METHODS AND COMPOSITIONS FOR THE SPECIFIC INHIBITION OF GLYCOLATE OXIDASE (HAO1) BY DOUBLE-STRANDED RNA) | ⤷ Try a Trial |
| Tunisia | 2017000125 | COMPOSITIONS AND METHODS FOR INHIBITION OF HAO1 (HYDROXYACID OXIDASE 1 (GLYCOLATE OXIDASE)) GENE EXPRESSION | ⤷ Try a Trial |
| Japan | 2022190116 | 標的化脂質 | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for lumasiran sodium
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3204015 | 301167 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LUMASIRAN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/20/1496 20201123 |
| 3581654 | PA2021008,C3581654 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: LUMASIRANAS; REGISTRATION NO/DATE: EU/1/20/1496 20201119 |
| 3204015 | C202230012 | Spain | ⤷ Try a Trial | PRODUCT NAME: LUMASIRAN, OPCIONALMENTE EN FORMA DE UNA SAL; NATIONAL AUTHORISATION NUMBER: EU/1/20/1496; DATE OF AUTHORISATION: 20201119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1496; DATE OF FIRST AUTHORISATION IN EEA: 20201119 |
| 3581654 | 2021038 | Norway | ⤷ Try a Trial | PRODUCT NAME: LUMASIRAN; REG. NO/DATE: EU/1/20/1496 20201124 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
