emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate · Gilead Sciences Inc · NDA 202123
Complera
Blocked by patent: US 10857102.
FDA has approved 1 generic application (ANDA) for Complera, though its earliest generic-entry date is 14 Jan 2033 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10857102 | drug product · sets the listed date | 14 Jan 2033 |
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
- Generic approved · ANDA 220232, Laurus · 202123-001Approved 4 Mar 2026Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 202123 · 001 · RLD | tablet, oral | 200MG;EQ 25MG BASE;300MG | 14 Jan 2033 |