A	B	C	D	E	F	G	H	I	J	K	L	M
1	Main
2		Brand Name	Duragesic
3		Generic Name	fentanyl transdermal system
4		Indication	Persistent Chronic Pain - moderate to servere.
5		Label	http://www.duragesic.com/duragesic/shared/pi/duragesic.pdf
6		Mechanism	Fentanyl is an opiod agonist analgesic 81x more potent than morphine. 336.5 molecular weight.
7			Interacts predominantly with opiod mu-receptor. These sites are located throughout brain, spinal cord & other tissues. Principal pharmacologic effect is on the CNS.
8			Elevates mood/euphoria/dysphoria. Depresses respiratory centers, cough reflex & constricts pupils.
9		IP	Approved 1990, Generics launched in January 2005 in US, Europe?
10			Ionsys was hoped to be the follow-on/life-cycle product but ran into serious issues.
11		Safety	LD50 in humans is 0.5-1mg/kg for opiate-naïve individuals. Respiratory depression.
12		Administration	Transdermal Patch. Patch provides controlled release vs oral/topical. Patch is worn for 72 hours.
13		Competition	Generic (started in Q105 in US), Mylan Laboratories / Sandoz. Cephalon's fentanyl portfolio (Fentora, Actiq).
14
15			2000	2001	2002	2003	2004	2005	2006	2007	2008	2009	2010
16		US
17		ROW
18		WW
19
20		Q106: generic competition in the US in January 2005. Generic versions also launched in Europe.
21		DURAGESIC®/Fentanyl Transdermal (fentanyl transdermal system) sales declined to $1.2 billion in 2007, a reduction of 10.1% from 2006. This decline was the result of the impact of generic competition in the U.S. and major international markets. Generic competition in the U.S. began in January 2005.