buprenorphine hydrochloride; naloxone hydrochloride · Edenbridge Pharms · NDA 204242
Zubsolv
Earliest generic entry, as listed · earliest of 6 marketed strengths
18 Sep 2032
Blocked by patent: US 10874661, US 10946010, US 11020387, US 11020388, US 11433066, US 8940330, US 9259421, US 9439900.
Listed patents · 10 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10874661 | product | 18 Sep 2032 |
| US 10946010 | product | 18 Sep 2032 |
| US 11020387 | product, use U-3131 | 18 Sep 2032 |
| US 11020388 | product, use U-3131 | 18 Sep 2032 |
| US 11433066 | use U-3131 | 18 Sep 2032 |
| US 8940330 | product | 18 Sep 2032 |
| US 9259421 | product | 18 Sep 2032 |
| US 9439900 | product | 18 Sep 2032 |
| US 8470361 | product, use U-1425 | 22 May 2030 |
| US 8658198 | product, use U-1494 | 3 Dec 2027 |
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
- 25 Oct 2026Generic approved · 204242-00115 Dec 2025
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 204242 · 001 · RLD | tablet, sublingual | EQ 1.4MG BASE;EQ 0.36MG BASE | 18 Sep 2032 |
| 204242 · 002 · RLD | tablet, sublingual | EQ 5.7MG BASE;EQ 1.4MG BASE | 18 Sep 2032 |
| 204242 · 003 · RLD | tablet, sublingual | EQ 8.6MG BASE;EQ 2.1MG BASE | 18 Sep 2032 |
| 204242 · 004 · RLD | tablet, sublingual | EQ 11.4MG BASE;EQ 2.9MG BASE | 18 Sep 2032 |
| 204242 · 005 · RLD | tablet, sublingual | EQ 2.9MG BASE;EQ 0.71MG BASE | 18 Sep 2032 |
| 204242 · 006 · RLD | tablet, sublingual | EQ 0.7MG BASE;EQ 0.18MG BASE | 18 Sep 2032 |