Question 1

Is there a generic for Inclisiran sodium?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Inclisiran sodium. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Inclisiran sodium?

Accepted Answer

LEQVIO (NDA 214012, NOVARTIS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Inclisiran sodium?

Accepted Answer

The Orange Book lists 10 patents against Inclisiran sodium products, with the earliest listed expiry in 2027. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Inclisiran sodium have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 3 marketing-exclusivity periods for Inclisiran sodium. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Inclisiran sodium are approved?

Accepted Answer

Inclisiran sodium is approved in the following dosage form: solution.

Patent	Expires	In	Type
8809292	May 10, 2027	in 11 mo	SubstanceProductU-4413
8222222	Dec 29, 2027	in 1 yr 7 mo	U-4249
10131907	Aug 24, 2028	in 2 yr 3 mo	SubstanceProductU-4413
9370582	Dec 04, 2028	in 2 yr 6 mo	SubstanceProductU-4413
8828956	Dec 04, 2028	in 2 yr 6 mo	SubstanceProductU-4413
10806791	Dec 04, 2028	in 2 yr 6 mo	Substance
8106022	Dec 12, 2029	in 3 yr 6 mo	SubstanceProductU-4249
10125369	Aug 18, 2034	in 8 yr 3 mo	SubstanceProductU-4413
12460206	Aug 18, 2034	in 8 yr 3 mo	SubstanceProduct
10851377	Aug 25, 2036	in 10 yr 4 mo	U-4413

Inclisiran sodium

Brand (NDA) products · solution

Marketing exclusivity (3)

Listed patents (10)

Inclisiran sodium — frequently asked questions

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