Generic Drugs News: November 2006 Archives

Impax Laboratories Inc. said Wednesday the U.S. Court of Appeals for the Federal Circuit remanded a patent issue back to the lower court, vacating its ruling that was in favor of Sanofi Aventis LLC.

Hayward-based Impax (OTCBB: IPXL) said the patent relates to the use of riluzole in treating amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease.

In December, U.S. District Court for the District of Delaware granted a preliminary injunction motion brought by Bridgewater, N.J.-based Aventis, which delayed the entry of Impax's generic version into the market.

LONDON (Reuters) - AstraZeneca Plc said on Wednesday it expected 2006 earnings per share to be at the lower end of its $3.85 to $3.95 forecast range following the launch of a copycat version of its heart drug Toprol XL on Tuesday.

The Anglo-Swedish drugmaker also said it had signed an agreement for Par Pharmaceuticals to distribute an authorised generic version of Toprol XL in the United States.

This follows the launch of an unauthorised copycat formulation by Novartis AG's Sandoz on Tuesday.

(c) Reuters 2006

CHICAGO -- Target Corp. expanded its $4 generic drug program to all of its U.S. pharmacies on Monday, moving beyond states where it was matching a plan offered by rival Wal-Mart.

Target said all of its 1,287 pharmacies across the United States would now offer some generic drugs for $4. It was not immediately clear which generic drugs were on Target's list. Previously, the discount retailer had matched the list of drugs being sold for $4 at Wal-Mart. 

Wal-Mart Stores Inc., the world's largest retailer, started selling certain generic drugs for $4 per prescription in Florida in September. Since then, Wal-Mart has brought the $4 drugs to 37 more states and said it plans to extend the plan to additional states as fast as it can.

NEW YORK (Reuters) - The newly empowered Democrats' vow to cut healthcare costs might spell bad news for the brand-name pharmaceutical industry, but could provide new momentum for generic drug rivals, the Wall Street Journal reported on its Web site on Tuesday.

Boosting the generics industry may prove to be a politically palatable way to follow up on the party's campaign promises, the paper reported.

It quotes Jake Hansen, a vice president at generic drug manufacturer Barr Pharmaceuticals Inc., as saying that because of the shift in Congress, next year could be the most important year to the generics industry since 1984 -- when Congress passed the law that opened the door to the modern generics business.

Bloomberg -- Alcon Inc., the world's largest eye- care company, sued Apotex Inc. to keep it from selling a generic version of the eye-allergy drug Patanol.

Apotex is seeking U.S. Food and Drug Administration approval to sell a copy of the treatment, whose key ingredient is olopatadine hydrochloride. Alcon, a Swiss company, and its Japanese partner Kyowa Hakko Kogyo Co. claim in a suit filed yesterday in Indianapolis the generic version would infringe a patent expiring in 2015. Patanol first got FDA approval in 1996.

Patanol is the top-seller in the U.S. for the treatment of allergic conjunctivitis, a cause of itching, redness and tearing. The U.S. market for eye-allergy treatments was $460 million last year, Alcon said in its annual report, without disclosing how much of that was in Alcon sales.

BENTONVILLE, Ark. - Wal-Mart Stores Inc., the world's largest retailer, said Thursday it is expanding its $4 generic prescription program to 11 additional states and adding 17 more prescriptions to the program.

The company is adding 502 stores in Idaho, Kentucky, Maine, Massachusetts, Nebraska, Oklahoma, Rhode Island, South Carolina, Utah, Washington and West Virginia, making the plan available in 38 states so far.

Wal-Mart said it intends to continue to push for expansion to other states as quickly as possible.

source - AP 

Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Eli Lilly and Company's ZYPREXA(R) Zydis(R) (Olanzapine) Orally Disintegrating Tablets, 5mg, 10mg, 15mg and 20mg. The Company anticipates receiving final approval following the expiration of the 30-month stay in April 2007.

There is currently a disagreement between Barr and Eli Lilly regarding the length of the patent on Zyprexa - and whether Barr is ultimately allowed to sell the generic drug has yet to be decided.

ZYPREXA (olanzapine) is indicated for the treatment of schizophrenia and for the short-term treatment of acute manic episodes associated with Bipolar I disorder.

A tentative approval reflects FDA's preliminary determination that a generic product satisfies the substantive requirements for approval, subject to the expiration of all statutorily imposed non-approval periods. A tentative approval does not allow the applicant to market the generic drug product.

Cholesterol lowering 'statin' drugs are cost effective in far more people than current guidelines recommend and should be considered for a wider range of people, say researchers in a study published online by the BMJ today.

Large trials have shown that lowering blood cholesterol levels with statins greatly reduces major vascular events, such as heart attacks and strokes, in people at high risk.

And research published in 2005 from the largest of those trials (the heart protection study) showed that when cheaper generic versions are used, several years of statin treatment is cost effective for a wide range of people with vascular disease or diabetes.

Medco Health Solutions Inc., the biggest U.S. drug-benefits manager, said Friday that third-quarter profit rose 19 percent on sales of biotechnology medicines and cheap generic copies of Zocor cholesterol pills and Zoloft antidepressants.

Net income climbed to $185.8 million, or 62 cents a share, from $156.7 million, or 53 cents, a year earlier, Franklin Lakes-based Medco said. Revenue gained 12 percent to $10.5 billion, helped by a 2005 acquisition. Profit beat analysts' estimates.

Medco, a middleman between drugmakers and health insurance plans, capitalized on patent expirations for Pfizer Inc.'s Zoloft and Merck & Co.'s Zocor, allowing sales of less-expensive pills at higher markups.