Biomedical Engineering Reference
In-Depth Information
daily treatment (Conley et al.
2008
). For chronic sufferers the connection to the
purple pill became emotional (Harris
2002
).
Anticipating the eventual entry of generics, AZ launched their second generation
ppi known as esomeprazole magnesium and branded as Nexium in March of 2001.
From March of 2001 through 2007 AZ spent between US$100 and US$240 million/
year advertising Nexium as “today's purple pill.” These Nexium media messages
were targeting educated professionals with GERD that could afford the treatment.
The Nexium pill itself was purple in color and included two or three gold stripes
suggestive of the additional effi cacy and denoting 20 and 40 mg dosages, respec-
tively. It was positioned as an improved medication because on average it took
shorter time (5 days vs. 7 days) for the GERD patient to experience relief relative to
omeprazole.
The Nexium launch sales activities included aggressive detailing to doctors with
a week of free samples for all qualifi ed patients. Nexium was initially priced at a
slight (4 %) discount relative to Prilosec in an effort to encourage patients, doctors,
insurance companies, and health benefi t managers to place Nexium on their formu-
lary of covered compounds and approve the purchase of the new purple pill. As soon
as the generic entered, Nexium's retail price was increased to US$5/pill. At that
point, AZ had ceased all Prilosec promotional activities and was phasing out distri-
bution of omeprazole as a purple pill.
9.3.3
Generics Maneuver for Entry
In order to be the fi rst bioequivalent generic product approved for market entry post
patent expiry
19
in October of 2001 generic companies including Genpharm, Andryx,
Dr. Reddy's Cheminor and Kremmers Urban Development Co. (KUDCO) fi led
ANDA's
20
in 1998 and 1999. The FDA grants a 6 month marketing exclusivity to the
fi rst generic company to realize ANDA approval.
To counter this action, AZ quickly sued all of the above fi rms based on orange
book patents
21
for coatings and manufacturing techniques that did not expire until
2007 and beyond. Such legal actions lead to a subsequent 30 month FDA delay of
those ANDA approvals for omeprazole.
19
The AZ molecule patent for omeprazole was in force when AZ entered the US market with
Prilosec as a purple colored pill in October of 1989. A Hatch Waxman extension based on NDA
approval delays at the US FDA was fi led and led to a patent term extension until April 2001. A
further 6 month marketing exclusivity was realized through pediatric studies that extended the
expiry date to October 2001. Additional US patents on manufacturing related inventions and the
enteric coatings used in popular Prilosec embodiments would expire a number of years after 2001
and were all listed on the FDA Orange book.
20
Some of these ANDA's had paragraph IV certifi cations asserting that the AZ patents were invalid.
21
AZ orange book patents in litigation w/generics included US Patents 4,786,505 and 4,853,230.
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