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inclisiran sodium · Novartis · NDA 214012

Leqvio

Earliest generic entry, as listed
25 Aug 2036

Blocked by patent: US 10851377, US 10851377, US 10851377. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 26 unexpired

PatentClaimsExpires
US 10851377use U-441325 Aug 2036
US 10851377use U-424925 Aug 2036
US 10851377use U-441425 Aug 2036
US 10125369substance, product, use U-441418 Aug 2034
US 10125369substance, product, use U-441318 Aug 2034
US 10125369substance, product, use U-424918 Aug 2034
US 12460206substance, product18 Aug 2034
US 8106022substance, product, use U-424912 Dec 2029
US 8106022substance, product, use U-441412 Dec 2029
US 8106022substance, product, use U-441312 Dec 2029
US 10806791substance4 Dec 2028
US 8828956substance, product, use U-42494 Dec 2028
US 8828956substance, product, use U-44134 Dec 2028
US 8828956substance, product, use U-44144 Dec 2028
US 9370582substance, product, use U-42494 Dec 2028
US 9370582substance, product, use U-44134 Dec 2028
US 9370582substance, product, use U-44144 Dec 2028
US 10131907substance, product, use U-424924 Aug 2028
US 10131907substance, product, use U-441424 Aug 2028
US 10131907substance, product, use U-441324 Aug 2028
US 8222222use U-424929 Dec 2027
US 8222222use U-441329 Dec 2027
US 8222222use U-441429 Dec 2027
US 8809292substance, product, use U-424910 May 2027
US 8809292substance, product, use U-441310 May 2027
US 8809292substance, product, use U-441410 May 2027

Exclusivities · 4 unexpired

ODE-555orphan drug (7 years)12 Feb 2033
I-985new indication (3 years)12 Feb 2029
NPPnew patient population12 Feb 2029
NCEnew chemical entity (5 years)22 Dec 2026

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

  • 24 Oct 2026Exclusivity expires within 90 days NCE · 214012-001

Products covered · 1

NDA · productFormStrengthListed expiry
214012 · 001 · RLDsolution, subcutaneousEQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)25 Aug 2036