raltegravir potassium · Msd Sub Merck · NDA 022145

Isentress Hd

Earliest generic entry, as listed
30 Mar 2032

Blocked by patent: US 10772888. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 4 unexpired

6 Orange Book listing rows for 4 patents, including 2 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 10772888use U-1663 · sets the listed date30 Mar 2032
US 9649311drug product21 Apr 2031
US 9649311 listing rowdrug product21 Oct 2030
US 9649311 listing rowpediatric extension21 Apr 2031
US 8771733drug substance, drug product, use U-2572 Jun 2030
US 7754731drug substance, drug product, use U-25711 Sep 2029
US 7754731 listing rowdrug substance, drug product, use U-25711 Mar 2029
US 7754731 listing rowpediatric extension11 Sep 2029

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 · 1

NDA · productFormStrengthListed expiry
022145 · 002 · RLDtablet, oralEQ 600MG BASE30 Mar 2032