Pharmaceutical patent challenges - Time for reassessment?

Nature Reviews Drug Discovery

Volumn 3, Issue 12, 2004, Pages 1057-1062

  Glass, Gregory ^a  

^a Gregory Glass Associates LLC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIHYPERTENSIVE AGENT; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CARVEDILOL; FLUOXETINE; GENERIC DRUG; METOPROLOL;

ARTICLE; CERTIFICATION; DRUG APPROVAL; DRUG INDICATION; DRUG INDUSTRY; DRUG RESEARCH; FINANCIAL MANAGEMENT; GOVERNMENT REGULATION; HUMAN; HYPERTENSION; LEGAL ASPECT; PATENT; PRESCRIPTION; PRIORITY JOURNAL; PROFIT; RISK ASSESSMENT;

DRUG INDUSTRY; DRUGS, GENERIC; PATENTS;

EID: 10444221008     PISSN: 14741776     EISSN: None     Source Type: Journal    
DOI: 10.1038/nrd1581     Document Type: Article

References (7)

1. Beers, D. O. Generic and Innovator Drugs: A Guide to FDA Approval Requirements 5th Edn (Aspen Law, New York, 1999).
2. United States Federal Trade Commission. Generic Drug Entry Prior to Patent Expiration: An FTC Study (Federal Trade Commission; 2002).
3. US Food and Drug Administration, Office of Generic Drugs. Paragraph IV Patent Certifications [online], http://www.fda.gov/cder/ogd/ppiv.htm (2004).
4. ParagraphFour.com. The Paragraph Four Report [online], http://www.paragraphfour.com (2004).
5. Medicare Modernization Act. Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, December 8 (2003).
6. DiMasi, J. A., Hansen, R. W. & Grabowski, H. G. The price of innovation: new estimates of drug development costs. J. Health Econ. 22, 151-185 (2003).
7. IMS Health. IMS reports 11.5 percent dollar growth in '03 U.S. prescription sales. Press Release [online], http://www.imshealth.com/ims/portal/front/articleC/0,2 777,6599_3665_44771558,00.html (2004).