emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate · Gilead Sciences Inc · NDA 208351
Odefsey
Blocked by patent: US 8754065 (pediatric extension), US 9296769 (pediatric extension).
FDA has approved 1 generic application (ANDA) for Odefsey, though its earliest generic-entry date is 15 Feb 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 · 2 unexpired
4 Orange Book listing rows for 2 patents, including 2 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8754065 | drug substance, drug product, use U-257 | 15 Feb 2033 |
| US 8754065 listing row | drug substance, drug product, use U-257 | 15 Aug 2032 |
| US 8754065 listing row | pediatric extension · sets the listed date | 15 Feb 2033 |
| US 9296769 | drug substance, drug product, use U-257 | 15 Feb 2033 |
| US 9296769 listing row | drug substance, drug product, use U-257 | 15 Aug 2032 |
| US 9296769 listing row | pediatric extension · sets the listed date | 15 Feb 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
- First generic approved · ANDA 214095, Apotex · 208351-001Approved 30 Jan 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 214095, Apotex · 208351-001Approved 30 Jan 2026Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208351 · 001 · RLD | tablet, oral | 200MG;EQ 25MG BASE;EQ 25MG BASE | 15 Feb 2033 |