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Although generic drugs account for a large proportion of prescriptions,
their value share of the world's largest national markets
is relatively small, due to ruthless price competition. However,
this proportion is set to grow over the next five years, for
the following reasons:
- Around a third of the top 35 molecules are due to lose
US and EU patent protection by 2004
- Continued pressure on healthcare budgets is driving
an increase in generic prescribing in most major markets
According to an IMS HEALTH report, Pharma
Prognosis International, the market share claimed by generic
drugs in the ten major pharmaceutical markets varies widely.
Patent legislation is a major influence on current levels
of generic market penetration.
Copy products have limited the opportunities for generics
in markets such as Spain, while early working provisions have
favoured the development of more established generic sectors
in markets such as Canada. However, with healthcare budgets
coming under increasing pressure, most governments have introduced
a range of measures designed to encourage broader generic
prescribing.
These include mandatory generic substitution requirements,
pricing restrictions, formularies, prescribing guidelines
and positive or negative lists. Generic market shares are
expected to rise from currently low levels in both Spain and
Italy during the next five years, largely as a result of government
policies.
Source: IMS HEALTH, Pharma Prognosis International
Canada already has a strong generics sector, with generic
drugs accounting for 19% of retail sector value in Canada
in 1999, while Germany (16%) and the UK (15%) also had significant
generic sectors. In the US, the generic share by value has
fallen from 11% in 1997 to 9% in 1999, largely due to the
absence of major new molecules coming off patent.
However, a series of major patent expiries from 2001 onwards
will give renewed impetus to the US generics market, which
is forecast to exhibit rapid growth between 2001-2004. Branded
drugs with aggregate US sales of close to $10bn are due to
come off patent in 2001-2002 alone.
These include AstraZeneca's Losec (omeprazole), the leading
molecule worldwide in 1999, in terms of sales, which is already
off patent in several countries and is facing intensifying
generic competition. Other major brands approaching patent
expiry include Merck & Co's Zocor (simvastatin), Bristol-Myers
Squibb's Pravachol (pravastatin) and Lilly's Prozac (fluoxetine).
The table below indicates patent expiry dates for the five
most important drugs that will be exposed to generic competition
in the major world markets during the next five years, ranked
in terms of current original brand sales.
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Most
Important Patent Expiries in Major Markets, 1999-2004
|
|
Country
|
1999
(inc. SPC)
|
2000
(inc. SPC)
|
2001
(inc. SPC)
|
2002
(inc. SPC)
|
2003
(inc. SPC)
|
2004
(inc. SPC)
|
| France
|
Omeprazole
|
Budesonide
|
|
Fluoxetine
Paroxetine Amoxicillin/ Clavulanic acid |
|
|
| Germany
|
Omeprazole
|
Lovastatin
|
Simvastatin Ciprofloxacin |
Cetirizine |
|
|
| Italy
|
Omeprazole
Enalapril Ceftriaxone Lisinopril |
|
Ranitidine |
|
|
|
| Japan |
Aciclovir
|
|
Simvastatin
Enalapril |
Pravastatin |
|
|
| Spain |
Ranitidine
|
|
Enalapril
|
Sertraline
|
Ciprofloxacin |
Aceclofenac |
| UK |
Paroxetine
Lisinopril |
Fluoxetine
|
Simvastatin |
Omeprazole |
|
|
| USA
|
|
Simvastatin
Pravastatin |
Omeprazole
Fluoxetine Loratadin |
|
|
|
Source:
IMS HEALTH
The potential for generic market growth is
not limited to the developed markets. 2000 could be the
year in which the generics market takes off in Latin America.
New legislation designed to promote generic drug use was
passed in Brazil during 1999 and the first true generics
appeared on the market in 2000. The government expects the
sector to be worth $700 million in three years' time.
Also, doctors in Mexico are now required by law to prescribe
generically for products on a list of 'interchangeable generics'
- a move that has encouraged an increase in the number of
generic manufacturers operating in the country. The first
'interchangeable generics' - certified as bioequivalent
- reached the Mexican market in the late 1990s.
Detailed information on patent expiry dates is available
from Patents
International
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