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GENERICS ON WAY SOONER? BUSH BACKS SHORTENED PATENT PERIODS.

Byline: Evan Pondel Staff Writer

A new mandate Monday that the Food and Drug Administration effectively speed up the introduction of generic drugs could save U.S. consumers more than $3 billion a year, but industry analysts say the proposal does little to curb soaring health care costs.

In a sector that is already riddled with rising hospital fees, spiking premiums and expensive medications, President George W. Bush is attempting to ``close the loopholes'' by making generic drugs more accessible. The new plan would improve access to generic drugs by changing regulations that govern patents.

Congressional Democrats assailed the plan as a stripped-down version of a Senate proposal recently rejected by Bush.

The proposed rules ultimately alter the playing field for brand-name drug makers by allowing more generic labels to enter the market. Clifford Hewitt, analyst with Legg Mason in Maryland, said large pharmaceutical companies have often cast a shadow on generic-drug makers by extending their patents.

``But if these companies could no longer extend their patents as easily, you would think drugs will eventually cost consumers less money,'' Hewitt said. ``Still this isn't anything new, and companies, just like consumers, have been struggling from the cost of drugs.''

Last spring, WellPoint Health Networks petitioned to reduce the cost of allergy drugs in an effort to improve consumers' access and save the company money by consolidating pricey prescriptions.

Joshua Raskin, an analyst with Lehman Brothers in New York, said it could cost $70 a month per member to provide prescription drugs.

A federal advisory panel recommended that nonprescription Claritin be approved so people could eventually buy the drug over the counter. And though a nonprescription form of the allergy drug ultimately depends on the Food and Drug Administration, Thousand Oaks-based WellPoint is advocating its approval.

``The problem is, if you're cutting costs on drugs, hospital fees are bound to go up,'' said Fariba F. Ghodsian, analyst with Roth Capital Partners in Los Angeles. ``It seems like we're trying to fix a problem by exacerbating another issue.''

HealthNet of California spends about $500 million a year on prescription drugs for its members. The company recently eliminated Claritin and Allegra from its list of recommended drugs. They were replaced by Clarinex, a more affordable allergy drug. Clarinex costs $15 less per prescription than Allegra and $25 less per prescription than Claritin, according to HealthNet.

``Any proposal that attempts to get a grip on the steep rise in pharmaceutical costs is a good one,'' said Brad Keiffer, a Health Net spokesman. ``Rising drug costs make it a challenging environment for us to maintain affordable access.''

But for the brand-name drug makers, rising costs are a result of the industry's evolution. The costs associated with manufacturing drugs increases as technologies advance, Ghodsian said.

Though Amgen Inc. doesn't have any generic competitors, the biotechnology giant's patents keep its products exclusive.

The Thousand Oaks-based company has patents on drugs that extend beyond 2010. ``So they are pretty well insulated,'' Ghodsian said. ``I don't expect them to feel any pressure from the FDA's new plan, either.''

The Bush administration didn't provide any sort of time line for its prescription drug plan. The new regulations stem from the Hatch-Waxman law passed in 1984.

``There has been a lot of pressure on the administration as of late from older Americans to take care of rising drug costs,'' Hewitt said. ``And though the administration has this so-called new proposal, its implementation is difficult to foresee at the moment.''

PATENTS EXPIRING

A look at the brand-name drugs whose patents are close to expiring. Patents already being litigated would not be affected by the administration's proposal.

Patents expiring in 2002

--Claritin by Schering-Plough

--Augmentin by GlaxoSmithKline

--Intron A by Schering-Plough

--Axid by Eli Lilly

--Relafen by GlaxoSmithKline

Patents expiring in 2003

--Cipro by Bayer

--Singulair by Merck & Co.

--Flovent by GlaxoSmithKline

--Flonase by GlaxoSmithKline

--Engerix-B by GlaxoSmithKline

Patents expiring in 2004

--Lovenox by Aventis Pharmaceuticals

--Diflucan by Pfizer

--Lupron by Tap Pharmaceutical

--Lamisil by Novartis Pharmaceuticals

--Paraplatin by Bristol-Myers Squibb

--Xenical by Roche Laboratories

Patents expiring in 2005

--Zocor by Merck & Co.

--Prevacid by Tap Pharmaceutical

--Zoloft by Pfizer

--Pravachol by Bristol-Myers Squibb

--Zithromax by Pfizer

--Biaxin by Abbott Laboratories

--Zofran by GlaxoSmithKline

--Aredia by Novartis Pharmaceuticals

--Zoladex by AstraZeneca

- Source: Generic Pharmaceutical Association

- Associated Press

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PATENTS EXPIRING (see text)
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Title Annotation:Business
Publication:Daily News (Los Angeles, CA)
Article Type:Statistical Data Included
Date:Oct 22, 2002
Words:722
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