metformin hydrochloride; pioglitazone hydrochloride · Takeda Pharms Usa · NDA 021842

Actoplus Met

Earliest generic entry, as listed
3 Feb 2029

Blocked by patent: US 9320714.

Listed patents · 2 unexpired

PatentClaimsExpires
US 9320714drug product · sets the listed date3 Feb 2029
US 9101660drug product22 Jan 2027

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

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 · 2

NDA · productFormStrengthListed expiry
021842 · 001 · RLD · discontinuedtablet, oral500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**3 Feb 2029
021842 · 002 · RLDtablet, oral850MG;EQ 15MG BASE3 Feb 2029