You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 29, 2024

Inclisiran sodium - Generic Drug Details

✉ Email this page to a colleague

« Back to Dashboard

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^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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
Novartis Pharmaceuticals	Phase 3

See all inclisiran sodium clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for inclisiran sodium

C10AX	Other lipid modifying agents
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for inclisiran sodium

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or 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
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	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		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	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

Subscribe to access the full database, or Try a Trial
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

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
Lithuania	2929031		⤷ Try a Trial
Australia	2012261570	Compositions and methods for inhibiting expression of the PCSK9 gene	⤷ Try a Trial
Spain	2392478		⤷ Try a Trial
Eurasian Patent Organization	201890571	СПОСОБЫ И КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ НАРУШЕНИЯ, АССОЦИИРОВАННОГО С ГЕНОМ ПРОПРОТЕИНКОНВЕРТАЗЫ СУБТИЛИЗИН/КЕКСИНОВОГО ТИПА (PCSK9)	⤷ Try a Trial
Japan	2011505426		⤷ Try a Trial
Japan	2019147846	オリゴヌクレオチドの送達剤としての糖質コンジュゲート (CARBOHYDRATE CONJUGATES AS DELIVERY AGENTS FOR OLIGONUCLEOTIDES)	⤷ Try a Trial
Eurasian Patent Organization	201100907	КОМПОЗИЦИИ И СПОСОБЫ ИНГИБИРОВАНИЯ ЭКСПРЕССИИ ГЕНА PCSK9	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for inclisiran sodium

Subscribe to access the full database, or Try a Trial
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	CA 2021 00016	Denmark	⤷ Try a Trial	PRODUCT NAME: INCLISIRAN; REG. NO/DATE: EU/1/20/1494 20201210
2929031	16/2021	Austria	⤷ Try a Trial	PRODUCT NAME: INCLISIRAN; REGISTRATION NO/DATE: EU/1/20/1494 (MITTEILUNG) 20201210
2929031	2021024	Norway	⤷ Try a Trial	PRODUCT NAME: INKLISIRAN; REG. NO/DATE: EU/1/20/1494 20201215
2929031	21C1021	France	⤷ Try a Trial	PRODUCT NAME: INCLISIRAN; REGISTRATION NO/DATE: EU/1/20/1494 20201210
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.

Summary for inclisiran sodium

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for inclisiran sodium

Recent Clinical Trials for inclisiran sodium

Anatomical Therapeutic Chemical (ATC) Classes for inclisiran sodium

Make Better Decisions: Try a trial or see plans & pricing

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for inclisiran sodium