This article was in WSJ. It looks like a great idea on paper , but unfortunately the company cannot convince the FDA.
"In the latest tack by a
pharmaceutical maker to delay generic competition, Irish specialty drug maker Warner Chilcott PLC is trying something new: adding
a line across the top of a tablet.
The line, or "score,"
doesn't affect the chemical composition of Warner Chilcott's Doryx medicine for
severe acne. Rather, it makes it easier for patients to divide and take the
tablets in thirds, according to the company's filing with the U.S. Food and Drug
Administration.
If U.S. regulators accept Warner
Chilcott's argument, generic drug makers seeking to copy Doryx will have to
give their proposed generic versions a makeover to match the double lines. That
could delay the approval of low-priced generic alternatives.
Brand-name companies,
seeking to hold on to sales for aging products, have employed a range of
tactics to distinguish their medicines enough to prevent or delay a generic.
Companies have tweaked doses by small amounts, bought up the suppliers of key
ingredients, and turned their lotions into creams and creams into ointments. If
Warner Chilcott succeeds, it may be the first time a simple scoring of a tablet
has hung up generic competition, according to health-care experts.
"This is a new
one," said Eileen Wood, vice president of pharmacy and health-quality
programs at CDPHP, a health plan in New York state.
More than 383,000
patients in the U.S. take Doryx, according to Wolters Kluwer Pharma Solutions,
a health-care data company. A 180-count bottle of the 150-milligram pills costs
more than $3,000 on retail sites like drugstore.com, while bottles of the
75-milligram generic costs $1,380. Doryx generated $172.6 million in 2010
sales, about 6% of total revenue at Warner Chilcott, which also makes Actonel
for osteoporosis and Loestrin 24 Fe birth-control pills.
The Doryx tablets had
one score, which generic drug makers were preparing to copy and put on the
market as early as Sept. 30, according to Shibani Malhotra, an RBC Capital
Markets analyst. On Sept. 21, Warner Chilcott added the second score, and two
days later asked regulators to reject copies that don't have the new
configuration.
Approving generic
tablets with just one score, Warner Chilcott said in its petition filed with
FDA, "would raise public health concerns." A doctor could write a
prescription for Doryx and instruct a patient to divide the tablet into thirds,
but a generic version with just one score would make it difficult to get the
right dose, the company said. (If a generic is approved as equivalent to a
brand-name drug, it can be freely substituted for the costlier version by
pharmacists.)
A 1984 federal law
authorized generic drugs in a bid to rein in what is now more than $300 billion
in yearly spending in the U.S. on brand-name drugs. Generic drugs can cost as
much as 90% less than patent-protected branded medicines, and they now account
for about 78% of the country's dispensed prescriptions, according to the IMS
Institute for Healthcare Informatics.
Only a handful of
drugs are dual scored, such as anti-nausea medicine Phenergan and methadone for
pain, whose optimal dose ranges broadly depending on each patient's response
and therefore requires frequent adjustments, Ms. Wood said.
AdverseEvents Inc., a
California firm that collects and analyzes side-effect reports filed with the
FDA, found six reports of side effects, including one death, during the past
seven years that it says could have resulted from splitting Doryx pills, but
the FDA's database doesn't categorize reports by pill splitting and the reports
don't prove medicines caused the reported side effects.
An FDA spokeswoman
declined comment, saying the agency can't discuss standing petitions."
UPDATE: FDA has rejected this reasoning and the generics can enter the market.
Nice try Warner Chilcott but not good enough :).
