cliffwatch

vutrisiran sodium · Alnylam Pharms Inc · NDA 215515

Amvuttra

Earliest generic entry, as listed
28 Jul 2036

Blocked by patent: US 10208307, US 10683501, US 11286486, US 12049628.

Listed patents · 13 unexpired

PatentClaimsExpires
US 10208307drug substance, drug product, use U-3396 · sets the listed date28 Jul 2036
US 10683501drug substance, drug product, use U-3396 · sets the listed date28 Jul 2036
US 11286486drug substance, drug product, use U-3396 · sets the listed date28 Jul 2036
US 12049628drug substance, drug product, use U-3396 · sets the listed date28 Jul 2036
US 10612024drug substance, drug product, use U-339614 Aug 2035
US 11401517drug substance, drug product, use U-339614 Aug 2035
US 10570391drug substance, drug product, use U-339616 Nov 2032
US 9399775drug substance, drug product, use U-339616 Nov 2032
US 8106022drug substance, drug product, use U-339612 Dec 2029
US 10806791drug substance4 Dec 2028
US 8828956drug substance, drug product, use U-33964 Dec 2028
US 9370581drug substance, drug product, use U-33964 Dec 2028
US 10131907drug substance, drug product, use U-339624 Aug 2028

Exclusivities · 4 unexpired

ODE-527orphan drug (7 years)20 Mar 2032
ODE-212orphan drug (7 years)13 Jun 2029
I-964new indication (3 years)20 Mar 2028
NCEnew chemical entity (5 years)13 Jun 2027

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

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 1

NDA · productFormStrengthListed expiry
215515 · 001 · RLDsolution, subcutaneousEQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)28 Jul 2036