Perrigo brings two new Products to market
Allegan pharmaceuticals maker Perrigo Co. has received FDA approval to produce a generic competitor to Johnson & Johnson’s Monistat-1 Combination Pack. The company also has acquired the rights to Novel Laboratories’ pending “abbreviated new drug application,” or ANDA, for the Halflytely and Bisacodyl Tablets Bowel Prep Kit.
The U.S. Food and Drug Administration approved Perrigo’s ANDA for over-the-counter versions of Johnson & Johnson’s miconazole nitrate vaginal cream and suppository, treatments for vaginal yeast infections and for external itching and irritation caused by such infections.
The approval includes 180 days of generic marketing exclusivity, according to an announcement from Perrigo.
Monistat-1 has had annual retail sales of approximately $90 million dollars, according to Perrigo. Perrigo was the first pharmaceutical company to file an ANDA containing a Paragraph IV certification, and the resulting patent litigation filed by Johnson & Johnson was previously dismissed.
"This is another example of Perrigo's commitment to innovation by challenging brand patents and bringing new products to market. These innovations help save OTC health care consumers more than an estimated $1 billion annually," said Perrigo Chairman and CEO Joseph C. Papa.
Perrigo announced in late May that it had acquired rights to Novel Laboratories’ pending ANDA for a generic version of the Braintree Laboratories brand of prep kit for colonoscopy patients. Braintree sales of the product were approximately $80 million, according to Wolters Kluwer, an information services company that studies the health care market.
Novel Laboratories believes it was first to file an ANDA containing a Paragraph IV Certification with the U.S. Food & Drug Administration, and therefore the product is expected to be approved with 180 days of generic exclusivity. The brand marketing exclusivity ends Sept. 24, 2010. The company has not been sued.
Under terms of the Perrigo/Novel agreement, Novel will manufacture the product exclusively for Perrigo.