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Innovation, development dynamics and...

Keyser, Donald Jeffrey.

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Innovation, development dynamics and market exclusivity in the U.S. drug industry, 1994--2006.

Record Type:	Language materials, printed : Monograph/item
Title/Author:	Innovation, development dynamics and market exclusivity in the U.S. drug industry, 1994--2006./
Author:	Keyser, Donald Jeffrey.
Description:	177 p.
Notes:	Source: Dissertation Abstracts International, Volume: 71-08, Section: A, page: 2971.
Contained By:	Dissertation Abstracts International71-08A.
Subject:	Economics, General. -
Online resource:	http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=3414915
ISBN:	9781124096742

Innovation, development dynamics and market exclusivity in the U.S. drug industry, 1994--2006.
Keyser, Donald Jeffrey.

Innovation, development dynamics and market exclusivity in the U.S. drug industry, 1994--2006. - 177 p.

Source: Dissertation Abstracts International, Volume: 71-08, Section: A, page: 2971.

Thesis (Ph.D.)--The University of Texas at Dallas, 2010.

The pharmaceutical industry is reliant upon innovation. The importance of innovation is seen in the development of a new chemical entity (NCE). NCEs provide important new therapies that lead to significant advances in medicine. A key component of NCE innovation is the development of patents. Patents provide 20 years of patent market exclusivity from the filing of a patent application with the Patent and Trademark Office. A unique aspect of the pharmaceutical industry is that substantial evidence of a NCE's safety and efficacy must be developed and reviewed by the Food and Drug Administration (FDA) before a company is allowed to market a drug in the United States. This evidence takes considerable time and money for a company to develop. The more time spent in development means a greater loss of patent market exclusivity for the company. The extent of patent market exclusivity directly impacts the return on investment and the profitability of the drug company. This study used NCE as the unit of analysis and evaluated the patent market exclusivity (dependent variable) for NCEs approved in the United States between 1994 through 2006. The initial utility patent and the last utility patent filed with the FDA for the NCE were used in the analysis. The number of days from market approval to the end of the patent market exclusivity for a NCE was measured. Independent variables developed for the study consisted of company characteristics, drug characteristics and temporal characteristics. Company characteristics were numbers of patents listed for each NCE, annual company sales and U.S. or foreign headquartered company. Drug characteristics were pharmacological class, orphan drug designation, and priority regulatory review. Temporal characteristics were year of approval, and patent law change. A tobit regression analysis with left censoring was utilized. There were 361 NCEs included in the data base with that number being reduced to 336 NCEs when annual company sales were introduced into the analyses. The study established a highly significant reduction in patent market exclusivity for NCEs between 1994 through 2006. The study established that numbers of patents and the size of the company as represented by annual sales significantly improved the patent market exclusivity although overall market exclusivity is still significantly reduced.

ISBN: 9781124096742Subjects--Topical Terms:

1017424
Economics, General.

Innovation, development dynamics and market exclusivity in the U.S. drug industry, 1994--2006.
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245 1 0 $a Innovation, development dynamics and market exclusivity in the U.S. drug industry, 1994--2006.
300 $a 177 p.
500 $a Source: Dissertation Abstracts International, Volume: 71-08, Section: A, page: 2971.
500 $a Adviser: Donald A. Hicks.
502 $a Thesis (Ph.D.)--The University of Texas at Dallas, 2010.
520 $a The pharmaceutical industry is reliant upon innovation. The importance of innovation is seen in the development of a new chemical entity (NCE). NCEs provide important new therapies that lead to significant advances in medicine. A key component of NCE innovation is the development of patents. Patents provide 20 years of patent market exclusivity from the filing of a patent application with the Patent and Trademark Office. A unique aspect of the pharmaceutical industry is that substantial evidence of a NCE's safety and efficacy must be developed and reviewed by the Food and Drug Administration (FDA) before a company is allowed to market a drug in the United States. This evidence takes considerable time and money for a company to develop. The more time spent in development means a greater loss of patent market exclusivity for the company. The extent of patent market exclusivity directly impacts the return on investment and the profitability of the drug company. This study used NCE as the unit of analysis and evaluated the patent market exclusivity (dependent variable) for NCEs approved in the United States between 1994 through 2006. The initial utility patent and the last utility patent filed with the FDA for the NCE were used in the analysis. The number of days from market approval to the end of the patent market exclusivity for a NCE was measured. Independent variables developed for the study consisted of company characteristics, drug characteristics and temporal characteristics. Company characteristics were numbers of patents listed for each NCE, annual company sales and U.S. or foreign headquartered company. Drug characteristics were pharmacological class, orphan drug designation, and priority regulatory review. Temporal characteristics were year of approval, and patent law change. A tobit regression analysis with left censoring was utilized. There were 361 NCEs included in the data base with that number being reduced to 336 NCEs when annual company sales were introduced into the analyses. The study established a highly significant reduction in patent market exclusivity for NCEs between 1994 through 2006. The study established that numbers of patents and the size of the company as represented by annual sales significantly improved the patent market exclusivity although overall market exclusivity is still significantly reduced.
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