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制药提价与抑制仿制药方式 472条(本栏目收费,不能显示细节,电话13136136841)
Orange book of Hatch- Waxman, 55
55
patent infringement litigation under Paragraph IV (Hatch- Waxman Act), 22
22
pharmaceutical explanation for strong patent rights, 8
8
Abbreviated New Drug Application (ANDA),21, 118
21 118
See also generic drug application;Hatch- Waxman Act (U.S., 1984) AbbVie, 6
6
Abilify (antipsychotic, Otsuka), 110,12
110 12
acceleration clauses, 57,59
57 59
Accupril (hypertension drug), 53,56
53 56
matching petitions to relevant generic applications, 120,121
120 121
need for FDA transparency in, 135,136
135 136
overview of methodology of empirical analysis of, 115,117
115 117
procedural block to curb, 132,133
132 133
punitive deterrents to curb, 133,135
133 135
simple prohibition to curb, 131,132
131 132
staggered petitions and, 100,102
100 102
timing data with generic applications and, 119
119
timing of filing in relation to final approval, 123,28
123 28
Crestor (statin, AstraZeneca), 108,110, 111,112
108 110 111 112
Daraprim (antimalarial and HIV infections drug,
Turing Pharmaceuticals), 9,10, 84
9 10 84
Delzicol (chronic ulcerative colitis drug, Warner Chilcott), 74,76
74 76
Doryx (antibiotic and antimalarial drug, Warner Chilcott), 100,102
100 102
dosage form defined, 27
27
Drug Price Competition and Patent Term Restoration Act, 21, 32
21 32
See also Hatch- Waxman Act (U.S., 1984)
drug pricing. See pharmaceutical pricing