Generic Drugs News: December 2006 Archives

chinaSHANGHAI, China-A Chinese court has upheld the validity of drug maker Pfizer Inc.'s patent for Viagra, ordering two companies to stop sales of generic versions of the erectile dysfunction treatment and pay compensation for trademark infringements, a court official said Thursday.

The Beijing No. 1 Intermediate People's Court ordered Beijing Health New Concept Pharmacy Co. to stop sales of blue pills similar to Viagra, according to a court official who gave only his surname, Wang.

More generic rivals approved for Zocor

zocor U.S. regulators cleared six more companies to begin selling generic copies of Merck & Co.'s cholesterol drug Zocor, signaling steeper price reductions.

The approvals posted on the Food and Drug Administration's Web site Wednesday are in addition to those granted Teva Pharmaceutical Industries Ltd. and Ranbaxy Laboratories Ltd. in June when Merck's patents expired. The new versions of the world's second-best-selling cholesterol-lowering pill will drive prices down as much as 70 percent, analysts said. Teva has been selling copies for 8 percent less than Merck.

The price drop may hurt sales of Pfizer Inc.'s Lipitor, the world's top-selling drug, with revenue last year of $12.2 billion, and the source of almost half of the New York-based drugmaker's profits. Lipitor prescriptions declined 6 percent in the fourth quarter as health plans encouraged patients to switch to generic copies of Zocor, Bear Stearns analyst John Boris said in a Dec. 21 research report.

Generic Proscar Approved


proscarHealthDay News -- The U.S. Food and Drug Administration has approved a generic version of Merck & Co.'s Proscar (finasteride). The drug is used to treat symptomatic benign prostatic hyperplasia (BPH), the medical term for an enlarged prostate.

More than half of men in their 60s and as many as 90 percent in their 70s and 80s have some symptoms of BPH, the U.S. National Institutes of Health says.

Approval to produce a 5 mg. generic version of finasteride was granted to Mylan Laboratories Inc., the Pittsburgh-based company said Tuesday.

In the year ending Sept. 30, total U.S. sales of finasteride 5 mg. tablets were $553 million, Mylan said.

Lobbyists focus on safety in debate over generic drugs


generic drugsWASHINGTON -- Biotechnology lobbyists attempting to slow the development of cheap generic versions of the world's most expensive drugs have been emphasizing questions about their safety in an effort to win support among the new Democratic leaders of Congress.

James C. Greenwood , a former congressman who is president of the Biotechnology Industry Organization , began raising qualms about drug safety with former colleagues on Capitol Hill even as the lawmakers were enlisting cosponsors for legislation to create a speedy mechanism for so-called biogenerics to reach the market.

"We think safety needs to be the primary concern. We think that in order to assure safety, you have to bring a full complement of data with the follow-on product," Greenwood told the Globe in a recent interview.

New schizophrenia drugs no better than generic


perphenazine.jpgby Shankar Vedantam

Treating schizophrenia with an older, cheaper drug, rather than with heavily promoted newer medications, reduces the cost by as much as 30 percent with no apparent difference in safety and effectiveness, according to the first study to examine the economic implications of antipsychotic drug prescribing practices in the United States.

The newer drugs, such as Zyprexa, Seroquel and Risperdal, have cornered the lucrative U.S. market for antipsychotic drugs at a cost of $10 billion a year -- or around $100 for every family.

The findings have roiled the field of psychiatry in a fierce debate over the study's implications and have triggered concerns it could lead public and private insurers to limit drastically which drugs they will pay for.