Kariva

NORTH WALES, Pa. -- In the universe of branded drugs and direct-to-consumer advertising, a name means everything. And in today's changing pharmaceutical landscape, the big guns in the generics industry are catching on, playing the name game in growing numbers.

On the branded front, all pharmaceutical products own three names: a chemical name, a generic name and a brand name. A branded drug is marketed under a specific trade name by a pharmaceutical manufacturer. Until recently, generic drugs never enjoyed that status. But the need to assign unique trade names to generic drugs has arrived, owing in part to a deluge of generic competition for drugs coming off patent, stronger pipelines and record numbers of abbreviated new drug applications.

Teva Pharmaceuticals USA, Watson Pharma and Barr Laboratories, ranked respectively by IMS Health as the No. 1, No. 3 and No. 10 generic drug makers by U.S. total prescriptions dispensed in 2003, are assigning unique names to generic drugs actively.

A dynamic name (think Kleenex), dominates a category by separating a product from its competitors. It also reinforces a unique position, creates a positive and lasting tie with its audience and becomes a no-cost public relations vehicle, according to San Francisco-based naming and branding agency Igor.

But unlike a box of tissues, when a pharmaceutical company goes to register a trademark for a product, the U.S. Food and Drug Administration and the World Health Organization--in addition to the U.S. Patent and Trademark Office--participate in the approval process, according to Testa, Hurwitz and Thibeault, a patent and intellectual property practice group.

While the USPTO is concerned mainly with whether a proposed trademark will be confused with an existing trademark, the FDA and WHO look to see if the name is in line with public health and safety concerns and whether it will be confused with other brand name products.

Generic drug makers, with their "no-name" drugs, are making their way through the trademark process for what appears to be purely practical purposes--at least for now.

Teva, for instance, manufactures bupropion hydrochloride 150 mg controlled-release tablets, the AB-rated generic equivalent of GlaxoSmithKline's Wellbutrin SR, marketed for the treatment of depression. Teva assigned the generic version the name Budeprion SR so pharmacists would not confuse it with the company's other generic formulation: bupropion hydrochloride 150 mg controlled-release tablets, the AB-rated generic equivalent of GlaxoSmithKline's Zyban, marketed for smoking cessation. Teva assigned that generic version the unique trade name Buproban.

Teva also has created color-coded shelf talkers for use behind the pharmacy counter, so pharmacists and pharmacy technicians know which version should be substituted for which branded drug. The shelf talker additionally serves as an easy way for pharmacy staff to identify which formulation to reorder when stocks are low. As part of an awareness and education initiative, Teva is promoting its shelf talkers to pharmacists nationwide through direct mail and journal ads, as well as through its company Web site.

Mylan Laboratories may find itself in a similar position with its generic drugs after it received FDA approval last month to market its levothyroxine sodium tablets, the AB-rated generic version of Jones Pharma's Levoxyl, marketed for the treatment of thyroid disease. Mylan now offers levothyroxine sodium tablets for the branded drugs Levoxyl; Unithroid, which Jerome Stevens Pharmaceuticals manufactures; and Synthroid, which Abbott Laboratories manufactures. Generic and branded tablets of levothyroxine may differ in the amount of levothyroxine they contain, as well as in the absorption rate and distribution of the drug throughout the body, so one generic levothyroxine may not have the same effect on the body as another generic or the branded drug.

Other examples of generic drug makers assigning unique trade names to drug formulations are largely seen in one therapeutic class: oral contraceptives.

Barr Laboratories, for instance, manufactures three generic versions of desogestrel and ethinyl estradiol tablets. Barr's trademarked Velivet is the generic version of Organon USA's branded oral contraceptive Cyclessa. Its Kariva 28 is the generic version of Organon USA's branded oral contraceptive Mircette. And finally, its Apri 28 is the generic version of Organon USA's branded oral contraceptive Desogen, as well as the generic version of Ortho-McNeil's Ortho-Cept.

Watson, another generic player in the oral contraceptive market, takes its trademarked drug names one step further. It promotes its trademarked drug Levora, levonorgestrel and ethinyl estradiol tablets, the generic version of King Pharmaceuticals' Nordette, on its Web site. The site, aimed at health care professionals, features the statement, "If you prescribe Nordette, choose Levora."

But according to Joe Grotzinger, director of marketing at Teva, the fact that generic drug makers are assigning unique trade names to their drug formulations will not necessarily impact whether a pharmacist will dispense a generic drug. But it will make the process more efficient, Grotzinger said.

"If you're aware there are two bupropion hydrochloride 150 mg controlled-release tablets and you run out of one, you have to look at the [national drug code] number to reorder. By having the trade name, it makes it one step easier for inventory management," he said.

But will assigning a unique trade name to a generic drug increase the chances a pharmacist will dispense a generic drug if available? "It's not our intention," Grotzinger said. "Whether it's happened, I don't know. We haven't studied it."

By generics now having unique trade names, one also may wonder whether there will come a time when a doctor will write a prescription for or a consumer will walk into a doctor's office or pharmacy and ask for a generic drug by its unique trade name.

When asked to comment on the possibility, Grotzinger said: "That would be conjecture. We're not promoting [trademarked generics] to physicians. We're doing this for convenience for pharmacists."

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