Doryx

Bloomberg News More than 383,000 patients in the U.S. take Warner Chilcott's Doryx, a medicine for severe acne.

Drug Maker's Ploy to Delay Generics: Add a Line to Pill Jonathan D. Rockoff 2011

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.

Drug Maker's Ploy to Delay Generics: Add a Line to Pill Jonathan D. Rockoff 2011

The line, or "score," doesn't affect the chemical composition of Warner Chilcott's Doryx medicine for severe acne.

Drug Maker's Ploy to Delay Generics: Add a Line to Pill Jonathan D. Rockoff 2011

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.

Drug Maker's Ploy to Delay Generics: Add a Line to Pill Jonathan D. Rockoff 2011

More than 383,000 patients in the U.S. take Doryx, according to Wolters Kluwer Pharma Solutions, a health-care data company.

Drug Maker's Ploy to Delay Generics: Add a Line to Pill Jonathan D. Rockoff 2011

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.

Drug Maker's Ploy to Delay Generics: Add a Line to Pill Jonathan D. Rockoff 2011

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.

Drug Maker's Ploy to Delay Generics: Add a Line to Pill Jonathan D. Rockoff 2011

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.

Drug Maker's Ploy to Delay Generics: Add a Line to Pill Jonathan D. Rockoff 2011

The company has a record of extending patents on drugs, including acne-treatment Doryx, by tweaking the formula or form of dosage.

Warner Chilcott's Shrewd Drug Gamble 2009

Food and Drug Administration has granted the company final approval for the generic version of Doryx, a drug used to treat bacterial infection, in 75 and 100 milligram tablets.

East West Bancorp: Premarket Trading - Yahoo! Finance 2010