INCLISIRAN SODIUM - Generic Drug Details
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What are the generic sources for inclisiran sodium and what is the scope of freedom to operate?
Inclisiran sodium
is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Inclisiran sodium has two hundred and eighteen patent family members in thirty-three countries.
One supplier is listed for this compound.
Summary for INCLISIRAN SODIUM
| International Patents: | 218 |
| US Patents: | 13 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 13 |
| DailyMed Link: | INCLISIRAN SODIUM at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for INCLISIRAN SODIUM
Generic Entry Date for INCLISIRAN 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.
Recent Clinical Trials for INCLISIRAN SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Novartis Pharmaceuticals | Phase 4 |
| Novartis Pharmaceuticals | Phase 2 |
| University of Oxford | Phase 3 |
US Patents and Regulatory Information for INCLISIRAN SODIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | 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 |
Expired US Patents for INCLISIRAN SODIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for INCLISIRAN SODIUM
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2011505425 | ⤷ Try a Trial | |
| China | 101484588 | Compositions and methods for inhibiting expression of the pcsk9 gene | ⤷ Try a Trial |
| Japan | 6215284 | ⤷ Try a Trial | |
| Chile | 2015001506 | Composiciones de arni de pcsk9 y métodos de usos de las mismas | ⤷ Try a Trial |
| Hong Kong | 1213598 | 組合物及其使用方法 (PCSK9 IRNA COMPOSITIONS AND METHODS OF USE THEREOF PCSK9 IRNA) | ⤷ Try a Trial |
| Japan | 5635412 | ⤷ Try a Trial | |
| European Patent Office | 2231195 | LIPIDES DE CIBLAGE (TARGETING LIPIDS) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for INCLISIRAN SODIUM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2929031 | 2190017-0 | Sweden | ⤷ Try a Trial | PRODUCT NAME: INCLISIRAN; REG. NO/DATE: EU/1/20/1494 20201210 |
| 2929031 | 122021000029 | Germany | ⤷ Try a Trial | PRODUCT NAME: LNCLISIRAN; REGISTRATION NO/DATE: EU/1/20/1494 20201209 |
| 2929031 | C202130028 | Spain | ⤷ Try a Trial | PRODUCT NAME: INCLISIRAN; NATIONAL AUTHORISATION NUMBER: EU/1/20/1494; DATE OF AUTHORISATION: 20201209; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1494; DATE OF FIRST AUTHORISATION IN EEA: 20201209 |
| 2929031 | 21C1021 | France | ⤷ Try a Trial | PRODUCT NAME: INCLISIRAN; REGISTRATION NO/DATE: EU/1/20/1494 20201210 |
| 2929031 | 2021024 | Norway | ⤷ Try a Trial | PRODUCT NAME: INKLISIRAN; REG. NO/DATE: EU/1/20/1494 20201215 |
| 2929031 | SPC/GB21/031 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: INCLISIRAN; REGISTERED: UK EU/1/20/1494(NI) 20201210; UK PLGB 00101/1202 20201210 |
| 2929031 | 301107 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: INCLISIRAN; REGISTRATION NO/DATE: EU/1/20/1494 20201210 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
