Hello question_will,
Thank you for your very interesting question.
Modafinil is sold in these different formulations:
Provigil
(United States, United Kingdom, Italy, South Korea)
Vigil
(Germany)
Modalert
(India)
Modavigil
(Australia, New Zealand)
Alertec or Vigicer
(Canada)
Modiadal
(Mexico, France, Sweden)
Cephalon Press Release, 2005
http://stocks.us.reuters.com/stocks/fullDescription.asp?symbol=CEPH.O&WTmodLOC=L2-LeftNav-8.5-FullDescription
"Outside of the United States, modafinil is approved in more than 30
countries, including France, the United Kingdom, Ireland, Italy and
Germany, for the treatment of excessive daytime sleepiness associated
with narcolepsy. In certain of these countries, Cephalon also has
approval to market modafinil to treat excessive daytime sleepiness in
patients with OSA/HS and/or SWSD."
Cephalon Press Release, 2002
"Cephalon Announces Modafinil Receives Marketing Clearance In
Australia, New Zealand and South Korea"
http://www.cephalon.com/newsroom/news_reader.aspx?ID=330060
Worldwide, most of these forms (including Vigil, Modiadal, and
Modavigil) are manufactured and sold by Cephalon Inc. However,
Modalert is sold by Sun Pharmaceuticals in India and Alertec is sold
in Canada by Draxis Health.
These countries require a prescription:
United States
United Kingdom (but with lesser restrictions than the United States)
Canada
Germany (same restrictions as United States; illegal to possess
without a prescription or license)
Australia
New Zealand
France
South Korea
-----------
Cephalon's patent on the drug expired in 2006. When a drug patent
expires, makers of generics often rush to the forefront and capture
business from the original drugmaker. However, this has not happened
yet due to an interesting court case begun by Cephalon. Four
companies applied to the US FDA for approval to market generic
versions of Provigil and they were all granted approval to make the
generics. Cephalon filed suit against all these companies for patent
infringement and the companies all settled out of court, in what some
have seen as a form of blackmail.
United Senior Action
"Help Challenge Drug Industry Attempts to Keep Generics off the Market"
http://www.usaindiana.org/challenge.cfm
"The case, which was filed in June 2006, claims that Cephalon, the
brand name manufacturer of Provigil, conspired with generic drugmakers
Teva, Ranbaxy, Barr and Mylan to keep generic versions of Provigil off
the market. The case alleges that when Cephalon's exclusive marketing
rights were set to expire, the generic companies applied for FDA
approval to market generic versions of the drug. Although the FDA
determined that each company had developed safe, effective and
bioequivalent generic versions of Provigil, they could not begin
marketing the drugs because Cephalon filed patent infringement
lawsuits against them.
Although they had strong arguments for invalidating Cephalon's patent
for Provigil, all four generic companies settled their cases with
Cephalon. Under these settlement agreements, each generic company
agreed to keep their generic versions of Provigil off the market until
2011 or 2012, in exchange for cash payments. The three payments to
Teva, Ranbaxy and Barr alone totaled up to $136 million."
Apotex, another generic drugmaker, has sued all the parties involved
alleging monopolistic practices.
"Apotex Accuses Cephalon and Four Generic Drug Companies of
Monopolizing the U.S. Market for Provigil"
http://www.orangebookblog.com/2006/07/apotex_accuses_.html
-----------
Provigil's sales (Cephalon)
2005-- $500 million
2004-- $289 million
2003-- $200 million
2002-- $150 million
2001-- $75 million
More than a million people have been prescribed Provigil in the United
States; since it is primarily approved for narcolepsy and there are
only 150,000-200,000 narcoleptics in the US, people are not just
taking it for narcolepsy but to remedy other sleep disorders. In
2004, the drug was approved for use with other sleep disorders such as
sleep apnea. At one point, it was being prescribed at the rate of
250,000 every three months.
"The Great Awakening:
With a Pill Called Modafinil, You Can Go 40 Hours Without Sleep -- and
See Into the Future"
By Joel Garreau
Washington Post Staff Writer
Monday, June 17, 2002
http://www.washingtonpost.com/ac2/wp-dyn?pagename=article&node=&contentId=A61282-2002Jun16¬Found=true
'There are only 125,000 to 250,000 narcoleptics in the United States.
Cephalon brags that hundreds of thousands of patients have taken
Provigil, with over a million prescriptions written as of 2001, and
sales soaring. Nonetheless, Cephalon spokesman Sheryl Williams says
that "we are not aware of any significant prescribing of the drug for
nonmedical conditions."'
In Cephalon's latest earnings call in October, the company reported
sales of $186.5 million for Provigil in the United States in the
previous three-month quarter and sales of $11 million in Europe, for a
combined total of $197.6 million in sales in three months. This
compared to a year earlier, when total earnings for that quarter were
$134 million combined. This meant that sales of Provigil increased by
almost 50% in the course of one year.
For the nine months ending on September 30, 2006, Provigil experienced
$494.5 million in sales in the US and $29 million in Europe, a 44%
increase from the year before.
The full balance sheet released by Cephalon can be seen here:
MSN Money
http://news.moneycentral.msn.com/provider/providerarticle.asp?feed=PR&Date=20061102&ID=6163626
Sales of Provigil are expected to increase even more:
Philadelphia Daily News
"Cephalon earnings more than double"
http://www.philly.com/mld/philly/business/15915834.htm
'"Provigil is on track to become our first billion-dollar product,"
said Frank Baldino Jr., founder and chief executive officer of
Cephalon, referring to the company's treatment for narcolepsy,
obstructive sleep apnea, and shift-work sleep disorder. Provigil
prescriptions were up 18 percent in the latest quarter, with sales of
$197.6 million.'
-----------
Vigil-- Germany
"Vigil" is simply a shortened version of the name Provigil, and Vigil
is marketed by Cephalon, the same company that markets the drug in
America under the Provigil moniker. It has been available in Germany
since 1998.
Cephalon Press Release
"Cephalon Receives Approval to Market Modafinil for Shift Work Sleep
Disorder in Germany"
http://www.cephalon.com/newsroom/news_reader.aspx?ID=750715
I could not find individual reports of sales in Germany or other
European countries, but instead all European numbers as seen above.
-----------
Modalert-- India
Some buyers of modafinil have stated that the Indian version,
Modalert, which is distributed by Sun Pharmaceuticals, is not as
effective as other forms of modafinil such as Provigil, manufactured
by Cephalon. The following thread clarifies why this may be:
"Re: PROVIGIL"
http://www.drugbuyers.com/freeboard/showthreaded.php?Number=312423
-------------
Alertec-- Canada
Alertec was made by Shire Pharmaceuticals in Canada until this year,
when Shire was divested by its parent company, Draxis Health, and
Draxis retained the rights to make and sell Alertec.
BioSpace-- Draxis Health Press Release
http://www.biospace.com/news_story.aspx?StoryID=20049020&full=1
-------------
Where do people buy it? How do they buy it?
Most people who take modafinil have a prescription. Ninety percent of
the prescriptions are for off-label usage-- to combat sleep
deprivation and other ailments. With a prescription, modafinil can be
readily obtained from any pharmacy or chemists'. Like any
prescription drug, it can also be bought at online pharmacies, which
may or may not have more competitive prices. Provigil is expensive.
If you are in the United States, Provigil is a Schedule IV controlled
substance, which means it's illegal to import it from a foreign
source. In other countries, it is not considered a controlled
substance and is not illegal to buy from other sources.
One thing a buyer of modafinil will find is that Provigil is more
expensive than Alertec or Modalert, the foreign forms of the drug.
This is because, while the different formulations are chemically the
same, Canadian and Indian manufacturers of the drug use different pill
shapes and formulas that are not covered under Cephalon's US patent.
Because they are "generics," although not official generics, Alertec
and Modalert are generally less expensive than Provigil.
Here are some places from which people have bought Provigil
successfully (with the recommendations I found):
Good Health Pharmacy
http://www.goodhealthpharmacy.com/new/catalog/product_info.php?ref=1&products_id=618&affiliate_banner_id=1
from:
"Modalert/Provigil CHEAP!"
topix.net
http://www.topix.net/forum/health/narcolepsy/T5G91I20L8QQNE68F
Quality Health-- UK
http://www.qhi.co.uk/list.asp
Biogenesis--
sells three different forms of modafinil
http://www.biogenesis-antiaging.com/advanced_search_result.php?search_in_description=1&keywords=modafinil&osCsid=6e324d4476e5bdd256f25eee7f9f3492&x=0&y=0
Modalert at Jan Drugs
http://www.jandrugs.com/momex/NavCode/drugs/DrugName/Provigil
Other recommendations from the Imminst.org thread are:
Freedom Pharmacy (Modalert)
http://freedom-pharmacy.com/Products2.asp?Brand=MODALERT+%28Modafinil%2CProvigil%29&T=m
Pharma-Orders
http://www.pharma-orders.com/advanced_search_result.php?osCsid=8612ccc28983aaef6d530636d20a1cb6&keywords=modafinil&osCsid=8612ccc28983aaef6d530636d20a1cb6&x=0&y=0
Sun Pharma-- Modalert
http://www.sunpharma.com/sunpharma-products/sunpharma-formulation/spopup13.php
Some posters recommend a site called airstream.com. I do not
recommend this site and it does not seem legitimate to me. On their
main page, the site has posted an announcement saying that they are
having difficulties with their credit card vendor and that they can
only accept wire transfers for now. The second a legitimate site had
problems with their credit card vendor, they would get a new one
rather than claim they could only accept wire payments. I do NOT
recommend buying any type of product from this site.
From:
Imminst.org Forum
"Modafinil Forms, Mediodal vs Alertec vs Provigil"
http://www.imminst.org/forum/index.php?s=&act=ST&f=169&t=10522&st=0&#entry109363
---
alt.med.fibromyalgia
"Provigil - Price went up!!"
http://groups.google.com/group/alt.med.fibromyalgia/browse_frm/thread/93c5ec5d63f6be8/fa3d710253dbc243?lnk=st&q=provigil+price&rnum=1&hl=en#fa3d710253dbc243
ABC Online Pharmacy
http://www.abconlinepharmacy.com/ns/customer/product2382-c-p1
Froogle Search for modafinil:
http://froogle.google.com/froogle?q=modafinil&btnG=Froogle+Search&ie=utf-8&oe=utf-8&scoring=p
-------------
Sources:
Boston Globe
"Who needs sleep? New pill hits scene"
By CAREY GOLDBERG
http://home.ease.lsoft.com/scripts/wa.exe?A2=ind0209C&L=wnn&T=0&F=&S=&P=13662
MSN Legalview-- Provigil
http://provigil.legalview.com/msn/
BLTC Research--
"Barr gets tentative OK
for narcolepsy drug"
http://www.modafinil.com/generic/index.html
Erowid-- Modafinil Laws
http://www.erowid.org/smarts/modafinil/modafinil_law.shtml
Search terms:
(on Google)
vigicer
india modalert prescription
sun pharmaceuticals modalert
modafinil sales
vigil modafinil sales
modafinil india sales
ranbaxy barr generic provigil
modalert sales
alertec sales
alertec sales shire
modafinil france prescription
modafinil australia prescription
modavigil sales australia
(on Google News Search)
modafinil sales
(Google Groups)
provigil price
If you need any additional clarification before rating, let me know
and I'll be happy to assist you. There were some parts of your
question which I was not completely clear if I was covering properly,
so if I have not, certainly inform me and I'll give you what
information you require.
--keystroke-ga |
Clarification of Answer by
keystroke-ga
on
02 Dec 2006 12:22 PST
Hello question_will,
Here are some legal and marketing issues related to the drug modafinil.
Legal--
Cephalon has run into trouble in the past for promoting its drugs for
off-label uses. In 2004, the Pennsylvania company was subpoenaed by
the Philadelphia U.S. Attorney's office regarding its marketing
practices. Fifty percent of Provigil sales are for off-label uses.
As with any other pharmaceutical company, Cephalon must deal with the
FDA. Cephalon attempted to get modafinil approved for children with
ADHD symptoms under the brand name Attenace or Sparlon. In August
2006, the FDA responded that Sparlon/Attenace had been rejected
because of a single case of Stevens Johnson syndrome in study. The
case was later shown not to be Stevens Johnson, but the FDA did not
change the ruling.
Still, some of the research was troubling.
http://www.scoop.co.nz/stories/HL0603/S00272.htm
"Just What Kids Need - Sparlon - Another ADHD Drug"
Monday, 20 March 2006
"Last week the FDA announced that an analysis provided by Cephalon as
part of its response to the FDA's 'approvable' letter found 4 suicidal
events, 2 events of psychosis/mania and 9 aggression events in the
double blind clinical studies of Sparlon, in a summary report for the
Pediatric Advisory Committee."
"'With respect to psychosis and mania events,' the memorandum wrote,
'although the numbers of such events with drug treatment were small,
the complete absence of such events with placebo treatment was
notable.'"
For information on a major legal barrier to Provigil, see the section
in my answer on the court cases that Cephalon has brought to prevent
other manufacturers from marketing a generic version of the drug.
Cephalon also applied in 2005 for over-the-counter status for
Provigil, horrifying some onlookers with the possibility that people
might try to self-medicate with the drug.
Marketing--
Modafinil only has approval for a few prescription purposes, including
narcolepsy and shift disorder. However, it is prescribed off-label by
physicians for a myriad of other disorders. Cephalon faces a quandary
in this instance because modafinil is useful, and used, for many more
things than it is approved for, but Cephalon cannot market directly to
these causes yet without approval.
New York Times
"A Biotech Outcast Awakens"
http://query.nytimes.com/gst/fullpage.html?sec=health&res=9401E6DE103DF933A15753C1A9649C8B63
The New York Times said of the drug:
"But the growing sales of Provigil are also raising questions about
the company's promotion of the drug and about society's use of it.
Already, some doctors say, Provigil is showing signs of becoming a
lifestyle drug for a sleep-deprived 24/7 society, used by people who
need to pull all-nighters for work or school or who just want to sleep
less so they can work or play more."
"Still, the F.D.A. admonished the company in January for advertising
Provigil in journals, on Web sites and via handouts to doctors as a
general remedy for sleepiness and fatigue rather than only for
narcolepsy, and for understating the side effects. Cephalon says it
has since changed its promotional material."
The military in both America and the UK has bought the drug in great
quantities,leading to concerns that soldiers are being plied with a
drug and forced to stay up for longer hours than they would otherwise.
Experts have questioned whether sleepiness is really a disorder that
needs treatment, or if it is simply a natural part of human life that
exists for humans' own health.
The National Institutes of Health is conducting a $10 million study on
whether modafinil can help cure cocaine addicts of their addiction.
If the preliminary results are repeated, it could be a huge windfall
for Cephalon and other modafinil makers. There is currently no
approved medical treatment for cocaine addiction. If modafinil is
approved for this use, it could gain a reputation similar to methadone
as a "drug addicts' drug." Cephalon may have a hard time marketing it
for other purposes if it is used to cure drug addiction. At the same
time, it is unlikely that modafinil would get the bad reputation that
methadone has, since it has a low addiction/abuse potential.
Cephalon also faces an uphill battle with insurance companies, who do
not want to pay for expensive Provigil when amphetamines are much less
expensive. The NHS of England mentions in its report on modafinil how
expensive the drug is in comparison to other drugs in its class:
NHS-- modafinil
http://www.refer.nhs.uk/ViewRecord.asp?ID=479
Sources:
Milwaukee Journal-Sentinel
"Pill may help break cocaine addiction"
http://www.jsonline.com/story/index.aspx?id=421677
"Modafinil May Help Cocaine Dependence"
http://alcoholism.about.com/od/cure/a/blup050110.htm
About:Pediatrics Provigil
http://pediatrics.about.com/od/adhdmedications/p/06_provigil.htm
Guardian
"Wired awake"
http://www.guardian.co.uk/life/feature/story/0,13026,1270902,00.html
The Neuroethics of New Drugs and Technology
By Lisa M. Krieger, (c) Mercury News, May 21, 2002
http://www.cognitiveliberty.org/news/neuroethics1.htm
Business Week
"This Pep Pill Is Pushing Its Luck"
http://www.businessweek.com/magazine/content/04_44/b3906099_mz018.htm
"Neural Enhancement: A Slippery Slope for Neurologists"
http://appneurology.com/showArticle.jhtml?articleId=184417512
Search terms:
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