cliffwatch

givosiran sodium · Alnylam Pharms Inc · NDA 212194

Givlaari

Earliest generic entry, as listed
3 Oct 2034

Blocked by patent: US 10119143, US 11028392.

Listed patents · 8 unexpired

PatentClaimsExpires
US 10119143substance, product, use U-26723 Oct 2034
US 11028392substance, product, use U-26723 Oct 2034
US 9133461substance, product, use U-267230 Nov 2033
US 10125364substance, product, use U-267215 Mar 2033
US 9631193use U-267215 Mar 2033
US 8106022substance, product, use U-267212 Dec 2029
US 8828956substance, product, use U-26724 Dec 2028
US 10131907substance, product, use U-267224 Aug 2028

Exclusivities · 1 unexpired

ODE-273orphan drug (7 years)20 Nov 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 ODE-273 · 212194-001

Products covered · 1

NDA · productFormStrengthListed expiry
212194 · 001 · RLDsolution, subcutaneousEQ 189MG BASE/ML (EQ 189MG BASE/ML)3 Oct 2034