indocyanine green · Renew Pharms · NDA 011525
Ic-Green
Earliest generic entry, as listed
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
- 25 Oct 2026Generic approved · 011525-0013 Aug 2026
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 011525 · 001 · RLD | injectable, injection | 25MG/VIAL | open |
| 011525 · 002 · discontinued | injectable, injection | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011525 · 003 | injectable, injection | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011525 · 004 · discontinued | injectable, injection | 40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |