emtricitabine; tenofovir alafenamide fumarate · Gilead Sciences Inc · NDA 208215
Descovy
Blocked by patent: US 12629338, US 12648911, US 12661323, US 12678408.
FDA has approved 2 generic applications (ANDAs) for Descovy, though its earliest generic-entry date is 29 Jun 2036 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 · 6 unexpired
13 Orange Book listing rows for 6 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 12629338 | drug product · sets the listed date | 29 Jun 2036 |
| US 12648911 | use U-1259, U-1663 | 29 Jun 2036 |
| US 12648911 listing row | use U-1259 · sets the listed date | 29 Jun 2036 |
| US 12648911 listing row | use U-1663 · sets the listed date | 29 Jun 2036 |
| US 12661323 | drug product · sets the listed date | 29 Jun 2036 |
| US 12678408 | drug product · sets the listed date | 29 Jun 2036 |
| US 8754065 | drug substance, drug product, use U-1259, U-1663, U-257 | 15 Feb 2033 |
| US 8754065 listing row | drug substance, drug product, use U-1259 | 15 Aug 2032 |
| US 8754065 listing row | drug substance, drug product, use U-1663 | 15 Aug 2032 |
| US 8754065 listing row | drug substance, drug product, use U-257 | 15 Aug 2032 |
| US 8754065 listing row | pediatric extension | 15 Feb 2033 |
| US 9296769 | drug substance, drug product, use U-1259, U-1663, U-257 | 15 Feb 2033 |
| US 9296769 listing row | drug substance, drug product, use U-1259 | 15 Aug 2032 |
| US 9296769 listing row | drug substance, drug product, use U-1663 | 15 Aug 2032 |
| US 9296769 listing row | drug substance, drug product, use U-257 | 15 Aug 2032 |
| US 9296769 listing row | pediatric extension | 15 Feb 2033 |
Exclusivities · 3 unexpired
| ODE-556 | orphan drug (7 years) | 20 Jun 2032 |
| ODE-554 | orphan drug (7 years) | 7 Jan 2029 |
| M-316 | miscellaneous (3 years) | 20 Jun 2028 |
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 214216, Macleods Pharms · 208215-001Approved 7 Apr 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 214173, Natco · 208215-001Approved 26 Aug 2026Detected 25 Oct 2026Historical import
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208215 · 001 · RLD | tablet, oral | 200MG;EQ 25MG BASE | 29 Jun 2036 |
| 208215 · 002 · RLD | tablet, oral | 120MG;EQ 15MG BASE | 29 Jun 2036 |