GSK knockoff gains approval

A generic drug manufacturer has won approval from U.S. regulators to sell cheaper copies of one of GlaxoSmithKline's best-selling drugs.

Par Pharmaceutical of Woodcliff Lake, N.J., said the Food and Drug Administration has approved its application to produce generic versions of GSK's Zofran tablets.

Zofran is taken by chemotherapy patients to prevent nausea and vomiting. The tablets also are taken by surgery patients to prevent postoperative nausea.

GSK, whose patent protection for Zofran has expired, is a key economic driver for the Triangle. The London-based pharmaceutical giant has about 6,000 local employees; that includes a manufacturing plant in Zebulon and a U.S. headquarters in Research Triangle Park.

Sales of brand-name prescription drugs typically tumble quickly after generic copycats that sell for drastically reduced prices enter the market.

Total U.S. sales of Zofran, which includes multiple versions of the drug, such as an oral solution and conventional tablets that are taken with water, totaled $999 million for the nine months that ended in September, according to GSK. Zofran was the company's sixth-best-selling drug in the U.S. market during that span.

But Par is producing only one version -- 4-milligram and 8-milligram tablets that dissolve in the mouth without water. GSK's annual U.S. sales of that version are about $300 million, Par said, citing data from IMS Health.

GSK is counting on its pipeline of new drugs -- considered one of the strongest in the pharmaceutical industry -- to boost overall sales and compensate for declines triggered by new generic competition. Several of its drugs are about to lose patent protection, including Lamictal for epilepsy, the migraine treatment Imitrex and Coreg, a heart medication.

GSK officials couldn't be reached for comment.

In the third quarter, GSK posted a $2.68 billion profit on $10.6 billion in revenue.

Par, which has begun shipping generic Zofran, said it has been awarded 180 days of market exclusivity among generics for being the first company to file for approval.

Par is producing the tablets, which will be sold by New Jersey-based Barr Pharmaceuticals' Pliva subsidiary. Par said the two companies will split the profits.

Par spokesman Peter Wolf declined to disclose the company's projection for generic Zofran sales, or the price the company will charge for the drug.

Par shares rose 60 cents to close at $22.20 on Tuesday. GSK's American depositary receipts, which are the equivalent of stock for foreign companies, fell 3 cents on Tuesday.