acoramidis hydrochloride · Bridgebio Pharma · NDA 216540

Attruby

Earliest generic entry, as listed
16 Aug 2039

Blocked by patent: US 11260047, US 12005043, US 12539290.

Listed patents · 13 unexpired

PatentClaimsExpires
US 11260047product16 Aug 2039
US 12005043product, use U-404616 Aug 2039
US 12539290product16 Aug 2039
US 11058668use U-404622 Mar 2039
US 12070449use U-404622 Mar 2039
US 10513497substance16 Feb 2038
US 11919865use U-404616 Feb 2038
US 10398681product5 May 2031
US 10842777use U-40465 May 2031
US 8877795product5 May 2031
US 9169214product, use U-40465 May 2031
US 9642838substance, product5 May 2031
US 9913826use U-40465 May 2031

Exclusivities · 2 unexpired

ODE-506orphan drug (7 years)22 Nov 2031
NCEnew chemical entity (5 years)22 Nov 2029

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
216540 · 001 · RLDtablet, oralEQ 356MG BASE16 Aug 2039