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 Type: Orphan Drug Exclusivity||Jul 20, 1990||Orphan Designation: Amelioration of recurrent attacks of acute intermittent porphyria (AIP) temporarily related to the menstrual cycle in susceptible women and similar symptoms which occur in other patients with AIP, porphyria variegata and hereditary coproporphyria.|
Hepatitis B Immune Globulin (Human) (Injection) (Intramuscular) Hepagam B
Drug Classes: Immunological Agents:Immunoglobulins == Immunological Agents:Vaccines
NDA Applicant: Kamada Ltd. BLA No.: 125035 Prod. No.: 001 Rx (>1560IU/5ML); 002 Rx (>312IU/ML)
|Exclusivity Type: Orphan Drug Exclusivity||Apr 6, 2014||Orphan Designation: Prevention of hepatitis B recurrence following orthotopic liver transplant|
Approved Labeled Indication: Prevention of hepatitis B recurrence following liver transplantation in HBsAG-positive liver transplant patients