eltrombopag olamine · Novartis · NDA 022291
Promacta
Earliest generic entry, as listed · earliest of 4 marketed strengths
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
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 220033, Hikma · 022291-001Approved 8 Apr 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 209938, Teva Pharms Usa · 022291-001Approved 13 Jul 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 216281, Zydus Pharms · 022291-001Approved 14 Jan 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 220660, Biocon Pharma · 022291-001Approved 28 Apr 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 208815, Actavis Labs Fl · 022291-001Approved 17 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 212884, Amneal · 022291-001Approved 14 Jan 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 220250, Msn · 022291-001Approved 14 Jan 2026Detected 25 Oct 2026Historical import
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022291 · 001 · RLD | tablet, oral | EQ 25MG ACID | open |
| 022291 · 002 · RLD | tablet, oral | EQ 50MG ACID | open |
| 022291 · 003 · RLD | tablet, oral | EQ 75MG ACID | open |
| 022291 · 004 · RLD | tablet, oral | EQ 12.5MG ACID | open |
| 022291 · 005 · RLD · discontinued | tablet, oral | EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
Expired or delisted (6)
- US 7547719 · — · 13 Jan 2026
- US 7547719 · substance, product, use U-1575 · 13 Jul 2025
- US 7547719 · substance, product, use U-2451 · 13 Jul 2025
- US 7547719 · substance, product, use U-2452 · 13 Jul 2025
- US 7547719 · substance, product, use U-1306 · 13 Jul 2025
- US 7547719 · substance, product, use U-930 · 13 Jul 2025