glecaprevir; pibrentasvir · Abbvie · NDA 209394, 215110
Mavyret
Earliest generic entry, as listed · earliest of 2 marketed strengths
5 Dec 2035
Other strengths are listed to 24 Dec 2036.
Blocked by patent: US 9321807.
Listed patents · 35 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11246866 | — | 24 Dec 2036 |
| US 11246866 | product | 24 Jun 2036 |
| US 9321807 | — | 5 Dec 2035 |
| US RE48923 | — | 8 Nov 2035 |
| US 9321807 | substance, product | 5 Jun 2035 |
| US RE48923 | substance | 8 May 2035 |
| US 10286029 | — | 14 Sep 2034 |
| US 11484534 | — | 14 Sep 2034 |
| US 10286029 | use U-4206 | 14 Mar 2034 |
| US 10286029 | use U-3238 | 14 Mar 2034 |
| US 10286029 | use U-3237 | 14 Mar 2034 |
| US 11484534 | use U-3237 | 14 Mar 2034 |
| US 11484534 | use U-4206 | 14 Mar 2034 |
| US 8937150 | — | 18 Nov 2032 |
| US 8648037 | — | 19 Jul 2032 |
| US 8937150 | substance, product | 18 May 2032 |
| US 8648037 | substance, product, use U-2141 | 19 Jan 2032 |
| US 8648037 | substance, product, use U-3238 | 19 Jan 2032 |
| US 8648037 | substance, product, use U-3237 | 19 Jan 2032 |
| US 8648037 | substance, product, use U-4206 | 19 Jan 2032 |
| US 9586978 | — | 6 May 2031 |
| US 10028937 | — | 10 Dec 2030 |
| US 10039754 | — | 10 Dec 2030 |
| US 9586978 | use U-4206 | 6 Nov 2030 |
| US 9586978 | use U-3238 | 6 Nov 2030 |
| US 9586978 | use U-2141 | 6 Nov 2030 |
| US 9586978 | use U-3237 | 6 Nov 2030 |
| US 10028937 | use U-2141 | 10 Jun 2030 |
| US 10028937 | use U-4206 | 10 Jun 2030 |
| US 10028937 | use U-3238 | 10 Jun 2030 |
| US 10028937 | use U-3237 | 10 Jun 2030 |
| US 10039754 | use U-4206 | 10 Jun 2030 |
| US 10039754 | use U-3238 | 10 Jun 2030 |
| US 10039754 | use U-2141 | 10 Jun 2030 |
| US 10039754 | use U-3237 | 10 Jun 2030 |
Exclusivities · 4 unexpired
| PED | pediatric (6 months added) | 10 Dec 2028 |
| I-967 | new indication (3 years) | 10 Jun 2028 |
| ODE-372 | orphan drug (7 years) | 10 Jun 2028 |
| PED | pediatric (6 months added) | 30 Oct 2026 |
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
- 24 Oct 2026Exclusivity expires within 90 days PED · 209394-00130 Oct 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 209394 · 001 · RLD | tablet, oral | 100MG;40MG | 24 Dec 2036 |
| 215110 · 001 · RLD | pellets, oral | 50MG/PACKET;20MG/PACKET | 5 Dec 2035 |
Expired or delisted (2)
- ODE-233 · 30 Apr 2026
- ODE-232 · 30 Apr 2026