epoprostenol sodium · Actelion · NDA 022260
Veletri
Earliest generic entry, as listed · earliest of 2 marketed strengths
15 Mar 2027
Blocked by patent: US 8318802.
FDA has approved 1 generic application (ANDA) for Veletri, though its earliest generic-entry date is 15 Mar 2027 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 · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8318802 | drug product · sets the listed date | 15 Mar 2027 |
| US 8598227 | — | 2 Feb 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
- Generic approved · ANDA 219237, Gland · 022260-001Approved 29 Dec 2025Detected 25 Oct 2026Historical import
- Enters 12-month window basis: patent · 022260-001Listed date 15 Mar 2027Detected 24 Oct 2026
- Enters 12-month window basis: patent · 022260-002Listed date 15 Mar 2027Detected 24 Oct 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022260 · 001 · RLD | injectable, injection | EQ 1.5MG BASE/VIAL | 15 Mar 2027 |
| 022260 · 002 · RLD | injectable, injection | EQ 0.5MG BASE/VIAL | 15 Mar 2027 |