Company names starting with "D"

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.


Daiichi Sankyo, Inc
Enhertu (For Injection) (Intravenous) fam-trastuzumab deruxtecan-nxki
NDA Applicant: Daiichi Sankyo, Inc      BLA No.: 761139  Prod. No.: 001 Rx (100MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJan 15, 2028Orphan 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

Dompé farmaceutici S.p.A.
Oxervate (Solution) (Topical) cenegermin-bkbj
NDA Applicant: Dompé farmaceutici S.p.A.      BLA No.: 761094  Prod. No.: 001 Rx (0.002% (20MCG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 22, 2025Orphan Designation: Treatment of neurotrophic keratitis
Approved Labeled Indication: Treatment of neurotrophic keratitis
Exclusivity Protected Indication: Treatment of neurotrophic keratitis



Last edited: 15 November 2022
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