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Senior Citizen Health & Medicine
Generic of the Statin Drug Zocor Approved by
FDA after Court Refuses Delay
 Cholesterol
drug cost to drop $14 million a year, says HealthPartners
Fourth generic approved this week; one for men's
hair loss
 June
23, 2006 – Hailing the action as an important step in the Food and Drug
Administration's effort to increase the availability of lower-cost
generic medications, the agency today approved the first generic version
of the statin Zocor (simvastatin). Last minute efforts by the drug
company Novartis to temporarily block the Simvastatin release, to allow
time to introduce its own generic version, was denied by a federal judge
earlier today. (Read the story on HealthPartners selling simvastatin
today below this report.)
Zocor, which grossed $4.4 billion in 2005 for its
distributor, Merck & Co., becomes the second statin to face generic
competition this year. The first, Pravachol, got a new generic
competitor called Pravastatin, when it was approved by the FDA in April.
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Brand-Name Drug Companies Paying Generic
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 April 26, 2006 – Yesterday, many senior citizens
welcomed the news of two new generic drugs being approved by
the Food and Drug Administration,
since an increasing number of studies show seniors can save large amounts of
money on generic drugs in the Medicare prescription drug program. The
bad news, however, was also reported yesterday by KaiserNet.org – the
brand-name pharmaceutical companies are paying off the generic drug
makers to not challenge their patents.
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FDA Approves Generic Cholesterol and Leg Pain Drugs
Encouraging news for senior citizens needing to
save on drugs
April 25, 2006 – Numerous studies have shown senior
citizens can save tremendous amounts of money by using generic drugs,
even in the Medicare prescription drug program. The Food and Drug
Administration today announced approvals for two generics that will be
of interest to many older people. The first, Pravastatin, is a generic
version of the cholesterol-lowering drug Pravachol. The second,
Cilostazol, is a generic for Pletal, which is prescribed for those who
get pain in the legs when walking.
Read more...
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Health & Medicine |
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Simvastatin is recommended for use along with a
diet restricted in saturated fat and cholesterol to treat
hypercholesterolemia (high cholesterol) and to reduce the amount of
certain fatty substances in the blood such as triglycerides and other
lipids.
According to the research firm, IMS Health, statins
accounted for $16 billion in U.S. sales in 2005. Zocor was the second
most widely prescribed statin.
"This approval is another example of our agency's
efforts to increase access to safe and effective generic alternatives as
soon as the law permits," said Gary J. Buehler, Director, Office of
Generic Drugs. "Simvastatin is a widely-used cholesterol lowering agent,
and its generic version can bring significant savings to the millions of
Americans with this disease."
Simvastatin Tablets (5 mg, 10 mg, 20 mg and 40 mg)
are manufactured by IVAX Pharmaceuticals, Inc. (IVAX) of Northvale, New
Jersey and simvastatin tablets (80 mg) are manufactured by Ranbaxy
Pharmaceuticals, Inc. of Princeton, New Jersey.
In addition to today's approval of Simvastatin, FDA
approved the following first generic products earlier this week:
● Finasteride Tablets, 1 mg (Propecia) -- for
the treatment of mild to moderate male pattern hair loss in men between
18-41 years of age.
● Finasteride Tablets, 5 mg, (Proscar) -- for the treatment of benign
prostatic hypertrophy (BPH) in men with an enlarged prostate to improve
symptoms by reducing the size of the prostate.
● Lamotrigine Tablets (Chewable), 5 mg and 25 mg (Lamictal) - therapy
for treating patients with seizures due to epilepsy.
The economic benefits of FDA's generic drug
approval program are significant because generics can cost a fraction of
the price of the brand name drugs and generic drugs represent about
two-thirds of total prescription doses sold in the U.S. in 2004,
according to IMS data on U.S. retail sales.
Competition from these four generics and from
future generics that are substitutable for these products may quickly
lead to reductions in spending of about $1 billion per year. This
estimate of savings assumes each drug attracts only two generic
competitors and these competitors would capture about 50% of the brand
name sales.
The savings would likely increase as more
competitors enter the market (See
http://www.fda.gov/cder/ogd/generic_competition.htm.)
The Office of Generic Drugs (OGD) states that it
continues working "expeditiously" to review and take action on generic
drug applications as quickly as possible. For more information on other
first generic versions, please see
http://www.fda.gov/cder/ogd/approvals/1stgen0506.htm
For additional information related to FDA's Office
of Generic Drugs, go to:
http://www.fda.gov/cder/consumerinfo/generic_equivalence.htm.
Cost for Treating High Cholesterol to Drop $14
Million Due to Zocor Generic
HealthPartners says their stores have
simvastatin and will begin sales today
June 23, 2006- HealthPartners, the largest
consumer-governed, non-profit health care organization, projects that
drug costs for treating high cholesterol will decline by as much as $14
million annually with the introduction of the Zocor generic.
The second-biggest-selling cholesterol-lowering
drug in the U.S., Zocor will now face the generic Simvastatin, which was
pre-shipped to all HealthPartners pharmacies and will be available for
sale beginning today.
"HealthPartners drug cost increases have dropped to
single digits for two years in a row and increased use of generics is
one of the biggest factors behind that trend," said Richard Bruzek, vice
president of HealthPartners pharmacy services. The average prescription
for Zocor is $171.
The final price for simvastatin has not yet been
released, but generic drugs are generally 30 to 80 percent lower than
the brand version.
Zocor is one of six top selling drugs that will
lose patent protection in 2006.
"Last year, six in ten prescriptions for our
members were for generic drugs and we expect that to increase five to
ten percent in 2006," said Bruzek. Since 2002, HealthPartners has
increased generic drug usage from 45 percent to 60 percent. Every one
percent increase in the use of generics reduces HealthPartners expenses
by nearly $5 million.
The availability of a generic version of Zocor will
also reduce out-of-pocket expenses for the 15,000 HealthPartners members
who take Zocor. The average co-pay for generic drugs is $20 less than
brand name drugs.
Another top-selling drug that will lose patent
protection this month is Zoloft, A generic version of the most commonly
prescribed drug for depression will become available beginning June 30,
2006.
About HealthPartners
HealthPartners (www.healthpartners.com)
is the largest consumer-governed, non-profit health care organization in
the nation with commercial and Medicare Advantage plans that received
the highest rating of "Excellent" from the National Committee for
Quality Assurance.
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