Patent lawsuit over Perrigo’s Monistat-1 dismissed
ALLEGAN, Mich. Perrigo on Thursday announced that the Hatch-Waxman litigation relating to Miconazole Nitrate Vaginal Cream and Suppository between Johnson & Johnson and Perrigo has been dismissed. Accordingly, Perrigo plans to launch a store brand version of the Monistat-1 Combination Pack following Food and Drug Administration approval, the company reported.
“This is another example of Perrigo’s commitment to continue bringing new store brand products to the market, stated Perrigo president and chief executive officer Joe Papa. “The one-day Miconazole cream and suppository introduction to the store brand market provides an important new product in the feminine hygiene category to our retail and wholesale customers while providing significant savings for the consumer. Perrigo is working every day to make quality healthcare more affordable.”
Earlier this year, Perrigo had been sued by Johnson & Johnson’s McNeil unit for infringement of a patent related to Perrigo’s filing of an ANDA for a generic to Monistat-1 Combination Pack in the United States District Court for the District of New Jersey.
Monistat-1 has annual retail sales of approximately $80 million dollars, Perrigo reported. The dismissal of the lawsuit ends the 30 month Hatch-Waxman stay period, which was originally set to expire in September 2010. Perrigo expects its pending launch to have 180 day first-to-file exclusivity.
FDA announces meeting to explore OTC flu treatments
ROCKVILLE, Md. Treatments to be used in the event of a pandemic flu epidemic may one day be available over-the-counter. The Food and Drug Administration on Tuesday announced a joint meeting of the Antiviral Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee in the Federal Register to determine the types of studies and trial designs needed for an influenza antiviral MedKit for the treatment or prevention of pandemic influenza.
The meeting will be held Oct. 29 at the Hilton in Rockville, Md.
According to the announcement, committee members will be tasked with providing advice on issues such as the role of personal MedKits, home stockpiling, non-prescription availability of influenza medications and interfaces of home readiness with public health systems.
Congressman recognized for stand against organized retail crime
WASHINGTON The Coalition Against Organized Retail Crime on Wednesday commended Rep. Bobby Scott, D-Va., chairman of the House Judiciary Committee, Subcommittee on Crime, Terrorism and Homeland Security for holding a hearing devoted to tackling organized retail crime.
The hearing is scheduled to take place Sept. 22.
Organized retail crime involves sophisticated crime rings that steal and stockpile huge quantities of merchandise that they then sell often to unwitting buyers. ORC gangs target high value consumer goods such as power tools, razors, over-the-counter medicines, items that are in high demand and are often easily concealable. The stolen merchandise is then sold through flea markets, swap meets, pawn shops and increasingly through internet auction sites.
Merchandise, such as baby formula and diabetic test strips, which can be damaged if not stored at proper temperatures, are often mishandled after being stolen, the coalition noted.
“With the recent introduction of three bills, Congress has taken a strong step forward to protect consumers and demonstrate their commitment to addressing organized retail crime,” the coalition stated.
In July Reps. Brad Ellsworth, D-Ind., and Jim Jordan, R-Ohio, introduced the Organized Retail Crime Act of 2008 (HR 6491). The bill would amend federal criminal code, making it illegal to engage in activities that further organized retail crime.
Soon after Scott introduced the E-Fencing Enforcement Act of 2008 (HR 6713), which addresses the selling of stolen goods online.
In the Senate, S. 3434, the Combating Organized Retail Crime Act of 2008, was introduced by Sen. Richard Durbin, D-Ill. The Durbin bill would clarify existing law to give law enforcement the tools to prosecute ORC, require online and offline marketplaces to investigate suspicious sales, and place basic disclosure requirements on online marketplaces.
The Coalition Against Organized Retail Crime, formed in 2001, is composed of 33 national manufacturing and retail organizations as well as individual companies that have come together to fight a new type of retail crime.