Sunday, March 4, 2012

Drug maker's ploy to delay generics: ADD A LINE TO PILL

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, 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 :).

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