Inclisiran sodium - Generic Drug Details
✉ Email this page to a colleague
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 nineteen patent family members in thirty-three countries.
One supplier is listed for this compound.
Summary for inclisiran sodium
International Patents: | 219 |
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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 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 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | LEQVIO | inclisiran sodium | SOLUTION;SUBCUTANEOUS | 214012-001 | Dec 22, 2021 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for inclisiran sodium
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 108220295 | PCSK9 iRNA组合物及其使用方法 (PCSK9 iRNA compositions and methods of use thereof) | ⤷ Sign Up |
European Patent Office | 2835429 | Compositions et procédés d'inhibition d'expression du gène PCSK9 (Compositions and methods for inhibiting expression of the PCSK9 gene) | ⤷ Sign Up |
Japan | 5843914 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 2017035340 | ⤷ Sign Up | |
Lithuania | PA2021510 | ⤷ Sign Up | |
Spain | 2702942 | ⤷ Sign Up | |
European Patent Office | 1608735 | CONJUGUES D'ARNI (IRNA CONJUGATES) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for inclisiran sodium
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2929031 | C20210012 00398 | Estonia | ⤷ Sign Up | PRODUCT NAME: INKLISIRAAN;REG NO/DATE: EU/1/20/1494 10.12.2020 |
2929031 | 132021000000077 | Italy | ⤷ Sign Up | PRODUCT NAME: INCLISIRAN(LEQVIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1494, 20201210 |
2929031 | 122021000029 | Germany | ⤷ Sign Up | PRODUCT NAME: LNCLISIRAN; REGISTRATION NO/DATE: EU/1/20/1494 20201209 |
2929031 | 16/2021 | Austria | ⤷ Sign Up | PRODUCT NAME: INCLISIRAN; REGISTRATION NO/DATE: EU/1/20/1494 (MITTEILUNG) 20201210 |
2929031 | 2021C/520 | Belgium | ⤷ Sign Up | PRODUCT NAME: INCLISIRAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1494 20201210 |
2929031 | LUC00209 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: INCLISIRAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1494 20201210 |
2929031 | PA2021510,C2929031 | Lithuania | ⤷ Sign Up | PRODUCT NAME: INKLISIRANAS; REGISTRATION NO/DATE: EU/1/20/1494 20201209 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |