lefamulin acetate · Hong Kong · NDA 211672, 211673
Xenleta
Earliest generic entry, as listed · earliest of 2 marketed strengths
25 Mar 2033
Other strengths are listed to 14 Jun 2036.
Blocked by patent: US 8071643.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12121582 | product | 14 Jun 2036 |
| US 8071643 | substance, product | 25 Mar 2033 |
| US 9120727 | substance, product | 23 May 2031 |
| US 8153689 | substance, product | 19 Mar 2028 |
Exclusivities · 1 unexpired
| GAIN | qualified infectious disease product | 19 Aug 2029 |
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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 211672 · 001 · RLD | tablet, oral | EQ 600MG BASE | 25 Mar 2033 |
| 211673 · 001 · RLD | solution, intravenous | EQ 150MG BASE/15ML (EQ 10MG BASE/ML) | 14 Jun 2036 |
Expired or delisted (1)
- NCE · 19 Aug 2024