Results tagged “generic drugs” from Drugs & Medicaments

Drug companies increasingly are reaching legal settlements that delay the introduction of cheaper generic medicines and cheat Americans of billions of dollars in savings, regulators on Wednesday told lawmakers seeking to ban the agreements.

The Federal Trade Commission and others allege the settlements allow brand-name pharmaceutical companies to pay off would-be generic competitors, which then agree to delay introduction of their less costly but otherwise identical versions of the original medicines.

The FTC issued a report Wednesday, to coincide with a Senate Judiciary Committee hearing on the topic, that shows the settlements have become more common since two 2005 appeals court decisions upheld their legality.

Jan. 11 (Bloomberg) -- Barr Pharmaceuticals Inc., the second-largest U.S. maker of generic drugs, is lobbying for a U.S. law that for the first time would routinely allow the sale of copies of medicines made from biotechnology.

"It's what we're eating and breathing," said Jake Hansen, Barr's chief lobbyist in Washington. The company is dispatching about a dozen representatives to press Congress for the law, along with lobbyists from other generic-drug makers. "It's definitely our main focus."

The biotech industry, which includes companies such as Amgen Inc. and Genentech Inc., is countering with its own lobbying campaign. The biotech drugmakers say making copies of gene-based medications, which are more complex than traditional treatments, could pose health risks.

DARMSTADT, Germany (AFX) - Merck KGaA is considering selling its generics drugs business to focus on new medication, according to a report in Handelsblatt newspaper, citing sources.

Merck (nyse: MRK )'s generics unit could be worth around 4 bln eur, added the report.

The company's supervisory board has already given 'the green light' to look for a buyer, the report stated, citing sources.

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.

Not all companies are getting what they want for Christmas. Taking on the form of the FDA, Santa has left a lump of coal in some corporate stockings when approvable letters were issued to four companies. Remember that receipt of an approvable letter means that the FDA has some outstanding issues that need to be resolved before an approval can be issued.

These outstanding issues can be quite complex, involving a great deal of time and investment, such as new clinical trials, or relatively simple, such as a label adjustment or a manufacturing process issue. In any case, it means a delay, either slight or lengthy, in getting to market.

New River Pharmaceuticals (NRPH) and Shire (SHPGY)- A second approvable letter was issued to these two companies for a treatment for Attention Deficit Hyperactivity Disorder [ADHD]. The first approvable letter was issued on October 6, 2006 and the company speedily submitted a response on October 24, 2006. According to Yahoo Finance, the FDA is not requesting new studies.

HealthDay 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.

WASHINGTON -- 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.

Those already in Washington, and those newly elected to Congress, who want to artificially control drug prices got an important lesson in economics last week. They also got a tutorial on why new lifesaving drugs are so expensive.

The lesson came as Pfizer, a leading pharmaceutical maker, canceled trials of a new cholesterol-controlling drug — torcetrapib.

As the stock market opened on Monday, Pfizer's announcement over the weekend sent its stock tumbling 14 percent, kicking the stuffing out of the company's estimated worth by more than $20 billion.

by 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.

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.