Perrigo files regulatory application for Taclonex generic
ALLEGAN, Mich. — Generic drug maker Perrigo has filed for approval of a drug to treat psoriasis with the Food and Drug Administration.
Perrigo announced Tuesday that it had filed an application with the FDA for calcipotriene and betamethasone dipropionate in the 0.005%/0.064% strength. The drug is a generic version of Leo Pharma’s Taclonex and is used to treat psoriasis vulgaris in adults.
Taclonex had sales of $135 million during the 12-month period ended in November 2010, according to Wolters Kluwer Health. Perrigo included in its application a Paragraph IV certification, a legal assertion that the patent covering Taclonex is invalid, unenforceable or won’t be infringed, attracting a patent infringement lawsuit from Leo, though a different generic company was the first to file for approval with the FDA.
Prasco agrees to distribute authorized generic of Pentasa
CINCINNATI — Prasco Labs will distribute an authorized generic version of an ulcerative colitis treatment made by Shire in the event that any other company steps forward to file an abbreviated new drug application for the drug.
Prasco announced an agreement with Shire US Manufacturing for mesalamine controlled-release capsules, an authorized generic of Shire’s Pentasa, in the 250-mg and 500-mg strengths, whereby Prasco will distribute the authorized generic when the Food and Drug Administration approves a generic version of the drug. At present, no generic version is available.
An authorized generic is a branded drug sold under its generic name at a discounted price, usually as part of an agreement between the branded drug’s manufacturer and a third-party company.
Medco’s Q4, fiscal-year sales rise
FRANKLIN LAKES, N.J. — Sales at Medco Health Solutions increased to $16.9 billion during fourth quarter 2010 and to $66 billion for the fiscal year as a whole, representing respective 11.1% and 10.3% increases over the same periods the year before, the pharmacy benefit manager said Tuesday.
Profits for the quarter were $378.5 million, a 10.8% increase over fourth quarter 2009, while profits for the year were $1.4 billion, an 11.5% increase over fiscal year 2009.
Specialty pharmacy sales for the quarter were nearly $3 billion and were more than $11.3 billion for the year, representing respective increases of 21.3% and 19.1% over the year before. The generic dispensing rate increased by 3.9% to 72.2% for the quarter, while increasing by 3.5% to 71% for the year as a whole.