FDA Orange Book · active-ingredient family
Difluprednate
Difluprednate is approved as 1 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DUREZOL · NDA 022212
1
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · emulsion
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DUREZOLRLD | SANDOZ | NDA 022212 | AB | Jun 23, 2008 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DIFLUPREDNATE | ALEMBIC | ANDA 213774 | AB | Jan 26, 2026 | |
| DIFLUPREDNATE | MYLAN LABS LTD | ANDA 212566 | AB | Mar 20, 2025 | |
| DIFLUPREDNATE | UPSHER SMITH LABS | ANDA 218191 | AB | Feb 11, 2025 | |
| DIFLUPREDNATE | CAPLIN | ANDA 219441 | AB | Dec 13, 2024 | |
| DIFLUPREDNATE | EPIC PHARMA LLC | ANDA 207284 | AB | May 14, 2024 | |
| DIFLUPREDNATE | DR REDDYS | ANDA 214894 | AB | Nov 16, 2022 | |
| DIFLUPREDNATE | AMNEAL | ANDA 211526 | AB | Nov 17, 2021 | |
| DIFLUPREDNATE | CIPLA | ANDA 211776 | AB | Aug 09, 2021 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Difluprednate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
