Content about Pharmaceutical companies

PHOENIX — Managed care and prescription plans are working to switch patients to generic versions of Pfizer's Lipitor despite the drug maker's efforts to reduce costs for the branded version, a new study suggested.

According to a report released Wednesday by Wolters Kluwer Pharma Solutions' inThought research group, while Lipitor (atorvastatin) has 41% of the market share of all dispensed prescriptions of atorvastatin, it has 35% of the payer approval volume.

PITTSBURGH — The Food and Drug Administration has approved an antimicrobial drug made by Mylan, the drug maker said Thursday.

The FDA approved Mylan's doxycycline hyalite delayed-release tablets in the 150-mg strength. The drug is a generic version of Warner Chilcott's Doryx.

WHAT IT MEANS AND WHY IT'S IMPORTANT — For all the fears about the patent cliff, at least one disease state seems to be on the up-and-up in terms of new drug development and new products.

(THE NEWS: FDA approves Bydureon. For the full story, click here.)

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said Thursday.

Merck announced the approval of Janumet XR (sitagliptin and metformin hydrochloride) extended-release tablets as a once-daily treatment for the disease.

IRVINGTON, N.Y. — Prestige Brands on Tuesday announced that it has completed its previously announced purchase of 15-of-the-17 brands it agreed to acquire from GlaxoSmithKline.

Prestige did not identify the two brand acquisitions not yet completed.

The former GSK brands represent approximately $200 million in annual revenues, which is projected to push Prestige annual revenues above $600 million, Prestige stated in an investor presentation in December.

NEW YORK — A possible pill mix-up has prompted Pfizer to recall more than two dozen lots of a prescription contraceptive drug, the drug maker said.

Pfizer announced the voluntary nationwide recall of 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) tablets and 14 additional lots of the drug's generic version. Pfizer manufactured and packaged the drugs, while Akrimax Pharmaceuticals commercialized them, and they were sold under the Akrimax brand.

INDIANAPOLIS — The Food and Drug Administration has approved a new treatment for Type 2 diabetes made by Eli Lilly and Boehringer Ingelheim, the drug makers said.

The FDA approved Jentadueto (linagliptin and metformin) tablets, designed to be taken twice daily. The approval marks the second since the two companies announced their collaboration to develop diabetes drugs in January 2011; the first drug approved under the Lilly-BI partnership was Tradjenta (linagliptin), approved in May 2011.

PARSIPPANY, N.J. — Watson Pharmaceuticals and Mallinckrodt have reached a settlement concerning a painkiller for which the former had sought Food and Drug Administration approval.

PARSIPPANY, N.J. — A federal court has stopped an injunction that would have prevented drug maker Watson Pharmaceuticals and partner company Amphastar Pharmaceuticals from marketing or selling a generic version of a blood-thinning drug.

One issue that is unlikely to see resolution this year is the growing problem of drug shortages. As of October 2011, the Food and Drug Administration and the American Society of Health Systems Pharmacists found shortages of 168 drugs. According to healthcare analytics firm IMS Health, while this represents a small and highly concentrated portion of the overall drug market, it includes a number of critical drugs used to treat cancer, infections, cardiovascular disease, central nervous system disorders and pain.

With the patent cliff and subsequent innovation drought moving closer, generic drug makers are looking to move up the value chain and pursue new sources of revenue, and of all the piles of pay dirt out there, biosimilars represent one of the closest things to an El Dorado, though regulations won’t take their final form for a while.


If the patent cliff were a sports team, Pfizer’s cholesterol-
lowering drug Lipitor (atorvastatin) would be its mascot. Because it’s the top-selling drug, well, ever — with 2010 sales well in excess of $7 billion in the United States alone — Lipitor’s loss of patent protection on Nov. 30, 2011, didn’t start or end the patent cliff but in many ways symbolized it.