Applicant, as named in the Orange Book
Am Regent
Next listed expiry: Injectafer on 15 Feb 2028. 4 products with live protection, 4 without.
Products with listed protection
| Drug | Earliest generic entry |
|---|---|
| Injectafer NDA 203565 · 4 strengths ferric carboxymaltose | 15 Feb 2028 patent, carve-out possible |
| Multrys NDA 209376 cupric sulfate; manganese sulfate; selenious acid; zinc sulfate | 1 Jul 2041 patent |
| Selenious Acid NDA 209379 · 3 strengths selenious acid | 1 Jul 2041 patent |
| Tralement NDA 209376 · 2 strengths cupric sulfate; manganese sulfate; selenious acid; zinc sulfate | 1 Jul 2041 patent |
Recent events
- Selenious Acid · Generic approved · ANDA 218536, StiraApproved 31 Dec 2025Detected 25 Oct 2026
- Selenious Acid · Generic approved · ANDA 219472, Emerge BioscienceApproved 3 Feb 2026Detected 25 Oct 2026
- Selenious Acid · Generic approved · ANDA 219322, Zydus PharmsApproved 30 Jun 2026Detected 25 Oct 2026
- Furosemide · Generic approved · ANDA 218188, Micro LabsApproved 8 Jan 2026Detected 25 Oct 2026
- Injectafer · First generic approved · ANDA 217076, MylanApproved 25 Jun 2026Detected 25 Oct 2026
- Injectafer · Generic approved · ANDA 217076, MylanApproved 25 Jun 2026Detected 25 Oct 2026
- Injectafer · First generic approved · ANDA 212572, Mylan Labs LtdApproved 25 Jun 2026Detected 25 Oct 2026
- Injectafer · Generic approved · ANDA 212572, Mylan Labs LtdApproved 25 Jun 2026Detected 25 Oct 2026
- Injectafer · First generic approved · ANDA 217769, MylanApproved 25 Jun 2026Detected 25 Oct 2026
- Injectafer · Generic approved · ANDA 217769, MylanApproved 25 Jun 2026Detected 25 Oct 2026
Products without listed protection (4)
| Drug | Earliest generic entry |
|---|---|
| Paclitaxel NDA 211875 paclitaxel | open now no listed protection |
| Vasopressin NDA 212593 · 2 strengths vasopressin | open now no listed protection |
| Venofer NDA 021135 · 3 strengths iron sucrose | open now no listed protection |
| Zinc Sulfate NDA 209377 · 3 strengths zinc sulfate | open now no listed protection |