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Industry faces new issues concerning generic drug regulations

BY Alaric DeArment

NEW YORK — While settlements constitute the most prominent patent-related issue for generic drugs, two others have cropped up this year as well.


In June, the Supreme Court said it would hear the case of Caraco Pharmaceutical Labs, Ltd. v. Novo Nordisk A/S, concerning Novo Nordisk’s Type 2 diabetes drug Prandin (repaglinide). Novo Nordisk had patent protection for the drug when combined with metformin, but not as a stand-alone therapy. Caraco sought approval of generic repaglinide for use alone, without metformin, under a provision of the Hatch-Waxman Act that allows the Food and Drug Administration to approve a generic version of a drug for approved uses not covered by any patent, allowing Caraco to avoid patent litigation. But Novo Nordisk changed its use code, a description of the patent required for FDA filing, to encompass use of Prandin alone, thus requiring the FDA to turn down Caraco’s approval application. Caraco filed a counterclaim requesting that Novo Nordisk be required to change the use code back to the original because its patents only cover Prandin in combination with metformin. 


Another issue is the America Invents Act, introduced in March. The Generic Pharmaceutical Association has expressed opposition to a provision of the bill that it said would allow patent holders who knowingly falsify or omit information in their original patent applications to retroactively correct their filings without any consequences. Generic drug companies frequently use falsifications and omissions in patent applications as a basis for challenging the validity of patents when they wish to market a generic version of a drug prior to patent expiration.

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Innovative nails

BY Antoinette Alexander

NEW YORK — It is no secret that nail polish is hot, and today’s beauty mavens are changing their nail shades as frequently as they change shoes or purses to complete an outfit or look. So why not offer a broad assortment of shades packaged in smaller bottles; after all, how many women finish an entire bottle of nail 
polish? Enter Pixel from Innovative Beauty.


Packaged in mini bottles (0.17 fl. oz.), the new Pixel brand is aptly named after the single point in a graphic image. The collection is comprised of 72 different shades, priced at $2.49 each, to bring even greater flexibility and accessibility to nail enamel.

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Pharma faces its own hurricane season

BY Alaric DeArment

At press time, Hurricane Irene was slowly barreling toward the East Coast and threatening the area with a deluge that prompted cities to shut down and had store shelves wiped clean.


A similar phenomenon is happening in the drug industry as the patent cliff barrels, Irene-like, toward branded and generic drug manufacturers alike, forcing them to scramble for new sources of revenue in the coming years. According to IMS Health, $102 billion worth of drugs will face generic competition between 2011 and 2015. This presents problems for branded drug companies, which must find a new business model to replace the traditional blockbuster drug model, as well as generic drug companies, which will find themselves competing for an ever-dwindling pool of top-selling molecules. “The most important [trend] has been the wave of patent expiries,” IMS Health VP industry relations Doug Long told Drug Store News.


Chief among these is Pfizer’s Lipitor (atorvastatin calcium), a drug with sales more than $7 billion per year in the United States alone and which is scheduled to go generic by the end of this year. A chance remains that Ranbaxy, the company planning to launch the generic, might face delays in getting approval from the Food and Drug Administration due to concerns about problems at its manufacturing plants in India. Watson is planning to launch an authorized generic version of the drug around the same time.


After the patent cliff, one trend that will likely accelerate is consolidation among generic drug makers. “I think you’ll see more of those types of things,” Long said. “I think the market’s still not consolidated enough. When some of these small molecules [decrease] after 2014, there will be more mergers.”


One merger highlighted by Long was Par Pharmaceutical’s acquisition last month of Anchen Pharmaceuticals, a $410 million deal that gave Par access to Anchen’s portfolio of injectable drugs. While companies like Hospira have long specialized in generic injectables, it’s a field in which many generic companies may take an increasing interest in the years to come. “People are starting to expand outside the oral solid generic business and getting into other, more specialty types of generics, like injectables in particular,” Long said.


Authorized generics may represent another area of opportunity. To be sure, authorized generics are controversial in the generics business, with groups like the Generic Pharmaceutical Association opposing them. Authorized generics are branded drugs marketed under their generic names at a reduced price, usually through a third-party company, such as the case with Watson’s authorized generic version of Lipitor. Under the Hatch-Waxman Act of 1984, the first company to file and win approval from the FDA for a generic version of a drug gets 180 days in which to market the drug in direct competition with the branded version, after which any generic company can apply for approval of a generic version, eventually resulting in the molecule becoming commoditized. 


But with authorized generics, the branded company can compete with the generic company on two fronts: one with its branded version and one with the cheaper authorized generic marketed by a third-party company. A number of traditional generics companies, such as Watson and Sandoz, market authorized generics, while others, such as Prasco, specialize in them. Despite the GPhA’s opposition, a study by the Federal Trade Commission found that while a generic drug could drive down the cost of the average $100 prescription by between $18.30 and $81.70, an authorized generic could drive it down by a further $8.10.

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