cliffwatch

cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate · Janssen Prods · NDA 210455

Symtuza

Earliest generic entry, as listed
19 Jul 2038

Blocked by patent: US 10786518. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 13 unexpired

PatentClaimsExpires
US 10786518use U-297819 Jul 2038
US 10039718product6 Oct 2032
US 8754065substance, product, use U-235215 Aug 2032
US 8754065substance, product, use U-276515 Aug 2032
US 9296769substance, product, use U-235215 Aug 2032
US 9296769substance, product, use U-276515 Aug 2032
US 8148374substance, product, use U-23533 Sep 2029
US 8148374substance, product, use U-23643 Sep 2029
US 8148374substance, product, use U-23653 Sep 2029
US 8148374substance, product, use U-27673 Sep 2029
US 8148374substance, product, use U-27663 Sep 2029
US 8148374substance, product, use U-27683 Sep 2029
US 7700645substance, product26 Dec 2026

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
210455 · 001 · RLDtablet, oral150MG;800MG;200MG;EQ 10MG BASE19 Jul 2038