Inclisiran sodium - Generic Drug Details
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What are the generic sources for inclisiran sodium and what is the scope of patent protection?
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 |
The TIMI Study Group | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for inclisiran sodium
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 | 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 | Y | 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 | ||||
>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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for inclisiran sodium
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 6034316 | ⤷ Try a Trial | |
Japan | 2023134489 | プロタンパク質転換酵素サブチリシン/ケキシン(PCSK9)遺伝子関連障害を治療するための方法および組成物 (METHODS AND COMPOSITIONS FOR TREATING PROPROTEIN CONVERTASE SUBTILISIN/KEXIN (PCSK9) GENE-ASSOCIATED DISORDER) | ⤷ Try a Trial |
Japan | 2007525454 | ⤷ Try a Trial | |
Canada | 2930393 | CONJUGUES GLUCIDIQUES UTILISES EN TANT QU'AGENTS D'ADMINISTRATION POUR DES OLIGONUCLEOTIDES (CARBOHYDRATE CONJUGATES AS DELIVERY AGENTS FOR OLIGONUCLEOTIDES) | ⤷ 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 | 132021000000077 | Italy | ⤷ Try a Trial | PRODUCT NAME: INCLISIRAN(LEQVIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1494, 20201210 |
2929031 | PA2021510,C2929031 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: INKLISIRANAS; REGISTRATION NO/DATE: EU/1/20/1494 20201209 |
2929031 | LUC00209 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: INCLISIRAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1494 20201210 |
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 |