Generic names starting with "H"

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.


Hemin for Injection (For Injection) (Intravenous) Panhematin
NDA Applicant: Recordati Rare Diseases, Inc.      BLA No.: 101246  Prod. No.: 001 Rx (350MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 20, 1990Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 6, 2014Orphan 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



Last edited: 15 November 2022
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