fidaxomicin · Cubist Pharms Llc · NDA 201699, 213138
Dificid
Earliest generic entry, as listed · earliest of 2 marketed strengths
31 Jan 2028
Other strengths are listed to 28 Nov 2034.
Blocked by patent: US 7378508, US 7863249, US 8859510.
Listed patents · 12 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9808530 | — | 28 Nov 2034 |
| US 9808530 | product | 28 May 2034 |
| US 7378508 | — | 31 Jan 2028 |
| US 7863249 | — | 31 Jan 2028 |
| US 8859510 | — | 31 Jan 2028 |
| US 7906489 | — | 4 Sep 2027 |
| US 7378508 | substance, product | 31 Jul 2027 |
| US 7863249 | substance, product | 31 Jul 2027 |
| US 8859510 | use U-319 | 31 Jul 2027 |
| US 8859510 | use U-2741 | 31 Jul 2027 |
| US 7906489 | use U-2741 | 4 Mar 2027 |
| US 7906489 | use U-319 | 4 Mar 2027 |
Exclusivities · 1 unexpired
| ODE-367 | orphan drug (7 years) | 24 Jan 2027 |
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
- 26 Oct 2026Exclusivity expires within 90 days ODE-367 · 201699-00124 Jan 2027
- 26 Oct 2026Exclusivity expires within 90 days ODE-367 · 213138-00124 Jan 2027
- 25 Oct 2026Generic approved · 201699-00113 Aug 2026
- 25 Oct 2026Generic approved · 201699-0017 Oct 2026
- 25 Oct 2026Generic approved · 201699-00127 Jan 2026
- 25 Oct 2026Generic approved · 201699-0012 Feb 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 201699 · 001 · RLD | tablet, oral | 200MG | 31 Jan 2028 |
| 213138 · 001 · RLD | for suspension, oral | 40MG/ML | 28 Nov 2034 |