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The
new
publication IMS World Review Generic
provides an overview of the unprotected and generic pharmaceutical
opportunities in eight key markets worldwide (France, Germany,
Italy, Spain, the UK, Canada, Mexico, and the USA) in 2001.
IMS
World Review Generic
covers sales of all molecules unprotected by the end of
2001, including brand name, branded generics etc. Taking
a closer look at the unbranded slice of data, worth $15.3
billion, provides some interesting statistics. IMS HEALTH
defines an unbranded product as one marketed under the same
name as the generic or compound name.
Top 10 unbranded products in 2001
(in
eight leading markets)
|
Rank
|
Compound
|
Original
brand name
|
Indication
|
|
1
|
acetaminophen
(paracetamol)
|
n/a
|
pain
|
|
2
|
fluoxetine
|
Prozac
|
depression
|
|
3
|
ranitidine
|
Zantac
|
heartburn,
gastric ulcers
|
|
4
|
albuterol
(salbutamol)
|
Ventolin
|
asthma
|
|
5
|
morphine
|
n/a
|
pain
|
|
6
|
acetylsalicylic
acid (aspirin)
|
n/a
|
pain
|
|
7
|
enalapril
|
Vasotec
|
hypertension
|
|
8
|
nifedipine
|
Adalat/Procardia
|
hypertension
|
|
9
|
buspirone
|
BuSpar
|
anxiety
|
|
10
|
atenolol
|
Tenormin
|
hypertension
|
Source:
IMS World Review Generic 2001
In
the eight covered markets, acetaminophen, known as paracetamol
in Europe, was unsurprisingly the top-selling unbranded
product. Close behind however, was fluoxetine, the active
ingredient in Eli Lilly’s blockbuster antidepressant Prozac,
which has an unfortunate claim to fame in that the brand
name drug’s sales fell at unprecedented speed following
the loss
of exclusivity in the US in August 2001. These
two products sell almost twice as much as the next batch
of compounds, at over $800 million and $700 million respectively
in the eight markets in 2001. Generic ranitidine, the compound
in GlaxoSmithKline’s ulcer and heartburn drug Zantac,
was third, but had under $400 million in sales.
The
fastest growing unbranded product in 2001 was buspirone,
despite originator Bristol-Myers Squibb’s attempts to prevent
Mylan’s launch of a cheaper copy of its BuSpar anxiolytic
by filing a new patent at the eleventh hour. A number of
US states are now suing BMS for improperly delaying BuSpar’s
generic competition. The compound with the second fastest
growth in sales was nabumetone, the copy of GSK’s arthritis
drug Relafen, then famotidine, better known as Merck’s
Pepcid, for heartburn and gastric ulcers.
Top
unbranded therapy classes
Given
the success of fluoxetine, it should come as no surprise
that antidepressants rank as the top therapy class in the
eight markets covered by IMS World Review Generic.
The two fastest growing therapy classes in terms of unbranded
sales in 2001 were bone calcium regulators (M5B) for osteoporosis,
and ophthalmic antiviral agents (S1D).
Top
10 unbranded therapy classes in 2001
(in eight leading markets)
|
Rank
|
Description
|
ATC
code
|
%
growth in US$
|
|
1
|
antidepressants
|
N6A
|
170%
|
|
2
|
non-narcotic
analgesics
|
N2B
|
8%
|
|
3
|
narcotic
analgesics
|
N2A
|
19%
|
|
4
|
anti-ulcerants
|
A2B
|
19%
|
|
5
|
calcium
antagonists, plain
|
C8A
|
42%
|
|
6
|
beta-blockers,
plain
|
C7A
|
27%
|
|
7
|
NSAIDs
|
M1A
|
28%
|
|
8
|
tranquilizers
|
N5C
|
74%
|
|
9
|
diuretics
|
C3A
|
7%
|
|
10
|
ß2-stimulants
|
R3A
|
40%
|
Source:
IMS World Review Generic 2001
Dynamic
company league tables
While
the top 10 list of large brand name pharmaceutical manufacturers
has been fairly stable for some years, with companies moving
up and down in terms of total sales largely due to
mergers and/or acquisitions, the rankings for unbranded
manufacturers are prone to more dramatic changes. A company
can move up merely by being the first to launch a copy of
a big selling drug, thanks to the 180-day generic exclusivity
legislation in the US.
Top
10 companies by 2001 sales of unbranded products
(in eight leading markets)
Source:
IMS World Review Generic 2001
While
the top 10 is made up of what many would describe as generic
manufacturers, such as Mylan and Teva, some of the brand
name companies also have significant unbranded operations,
including Merck KGaA, Abbott, and particularly Novartis,
predominantly through its Geneva subsidiary.
In
an interview with a Swiss newspaper in September 2002, head
of the unit Christian Seiwald said Novartis aimed to increase
its generic sales by 15% each year, in line with the overall
generic market. By comparison, Novartis expects the total
global pharmaceutical market to grow by 10% per annum. Novartis
is working on copies of all the major blockbuster products
due to lose exclusivity over the next five years - which
it estimates have annual sales of $45 billion. Earlier in
the month, the Swiss giant made a bid for Slovenian generic
manufacturer Lek, which produces a copy of GlaxoSmithKline's
top-selling antibiotic Augmentin; GSK has sued Geneva,
Teva, and others citing patent infringement.
Par,
Barr storming ahead
In terms
of US dollar growth in the eight key markets, from the top
10 unbranded manufacturers Par (a subsidiary of Pharmaceutical
Resources Inc) and Barr led the pack; Barr profited from
a 180-day period for one formulation of fluoxetine, while
Par has alliances with both Merck KGaA and the Indian manufacturer
Dr Reddy's.
Growth
rates for top 10 companies by 2001 sales of unbranded products
(in eight leading markets)
Source:
IMS World Review Generic 2001
Outside
the top 10, another Indian company, Ranbaxy, was the second
fastest growing for unbranded sales in 2001. Its 380% increase,
however, was dwarfed by Andrx's of nearly 6,000%. The Florida
company has kept a high profile, not least through its deal
with Aventis for Cardizem CD, and its predominant
role in the 2002
New York court case seeking to invalidate AstraZeneca
patents covering the ulcer drug Prilosec/Losec.
Future
looks bright
Findings
from
IMS Consulting research appear to support an
optimistic outlook for the unbranded manufacturers. It expects
the unbranded market to outperform the total, with a compound
annual growth rate of 13% through 2006. Three of the largest
brand name manufacturers have generic exposure representing
25-40% of their sales over the period. While profitability
within the unbranded sector is modest, volumes will rise
due to these opportunities and government schemes to reduce
health spending through the use of generics.
The
innovating companies are not taking the situation lying
down. Apart from strenuous patent litigation, companies
like AstraZeneca and Schering-Plough are trying to
extend the lifecycle of their drugs through the introduction
of follow-on products: for example Nexium to replace
Prilosec and Clarinex to replace Claritin.
Switching the original products from prescription-only to
over-the-counter status is another tactic. Nevertheless,
the fate of Prozac stands as an uncomfortable reminder of
one potential outcome after the loss of exclusivity.
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