Applicant, as named in the Orange Book
Legacy
Next listed expiry: Brisdelle on 6 Apr 2029. 4 products with live protection, 11 without.
Products with listed protection
| Drug | Earliest generic entry |
|---|---|
| Brisdelle NDA 204516 paroxetine mesylate | 6 Apr 2029 patent |
| Naftin NDA 204286 naftifine hydrochloride | 31 Jan 2033 patent |
| Esbriet NDA 022535 pirfenidone | 30 Aug 2033 patent, carve-out possible |
| Esbriet NDA 208780 · 2 strengths pirfenidone | 28 Mar 2037 patent |
Recent events
- Esbriet · Generic approved · ANDA 212597, Aurobindo PharmaApproved 20 Apr 2026Detected 25 Oct 2026
Products without listed protection (11)
| Drug | Earliest generic entry |
|---|---|
| Betapace NDA 019865 · 4 strengths sotalol hydrochloride | open now no listed protection |
| Betapace Af NDA 021151 · 3 strengths sotalol hydrochloride | open now no listed protection |
| Cloderm NDA 017765 clocortolone pivalate | open now no listed protection |
| Ethyol NDA 020221 amifostine | open now no listed protection |
| Imuran NDA 016324 azathioprine | open now no listed protection |
| Lotronex NDA 021107 · 2 strengths alosetron hydrochloride | open now no listed protection |
| Motofen NDA 017744 atropine sulfate; difenoxin hydrochloride | open now no listed protection |
| Naftin NDA 019599 naftifine hydrochloride | open now no listed protection |
| Ridaura NDA 018689 auranofin | open now no listed protection |
| Zanaflex NDA 020397 tizanidine hydrochloride | open now no listed protection |
| Zanaflex NDA 021447 · 3 strengths tizanidine hydrochloride | open now no listed protection |