A balancing act in the United States Drug Industry: Pioneer and generic drugs, the Orange Book, marketing protection and the US consumer

World Patent Information

Volumn 26, Issue 2, 2004, Pages 123-129

  Holovac, Mary Ann ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Bioequivalence; Drug effectiveness; Drug safety; Generic drug; Grandfather drug; Kefauver Harris; Marketing exclusivity; NDA; New drug application; Orange Book; Orphan drug; Patent certification; Patent protection; Pediatric drug; Pharmaceutical products; Therapeutic equivalence; Waxman Hatch

Indexed keywords

EID: 2342510394     PISSN: 01722190     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.wpi.2003.11.003     Document Type: Article

References (3)

1. http://www.fda.gov/oc/initiatives/generics/default.htm
2. Approved Drug Products with Therapeutic Equivalence Evaluations, 23rd Edition, 2003. US Government Printing Office
3. http://www.fda.gov/cder