Patents whose numbers are in italics have been extended under 35 USC 156. Unless otherwise noted, all expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jan 15, 2028 | Orphan Designation: Treatment of gastric cancer, including gastroesophageal junction cancer Approved Labeled Indication: treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen Exclusivity Protected Indication: treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen |
Dompˇ farmaceutici S.p.A.
Oxervate (Solution) (Topical) cenegermin-bkbj
NDA Applicant: Dompˇ farmaceutici S.p.A. BLA No.: 761094 Prod. No.: 001 Rx (0.002% (20MCG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Aug 22, 2025 | Orphan Designation: Treatment of neurotrophic keratitis Approved Labeled Indication: Treatment of neurotrophic keratitis Exclusivity Protected Indication: Treatment of neurotrophic keratitis |