Generics

One of the main plotlines of the big story called the drug industry over the past several years has been the patent cliff, the steady loss of patent protection on blockbuster primary care drugs and subsequent generic competition that has forced many drug companies to find new revenue streams. Much of this has taken place in the form of a gradual shift to specialty drugs for such conditions as cancers and autoimmune disorders, but recent developments have shown that primary care drugs may still have some steam left in them.


MORRISVILLE, N.C. — Poor medication adherence is a national problem, but it can be particularly problematic among populations with low health literacy or limited English proficiency.

A deal between two companies aims to provide mobile medication adherence services to both groups. Polyglot Systems and CellepathicRx have partnered to use CPRx's mobile health platform to deliver Polyglot's Meducation content to hard-to-reach patients through mobile Web and email technologies and smart phone applications.

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 — Mylan is changing the name of its branded specialty pharmaceutical business, the company said Wednesday.

The drug maker announced that it would change the name of Dey Pharma to Mylan Specialty. Dey makes treatments for respiratory diseases, psychiatric disorders and severe allergic reactions, including the EpiPen (epinephrine).

PITTSBURGH — Generic drug maker Mylan plans to challenge a court decision that requires it to pay almost $20 million to a drug company whose product it tried to market as a generic.

Sunovion Pharmaceuticals sued Mylan and several subsidiaries in the U.S. District Court for the District of Delaware when the latter sought to market a generic version of Sunovion's Xopenex (levalbuterol hydrochloride) inhalation solution, a drug for asthma and chronic obstructive pulmonary disease. The jury's verdict includes an $18 million award.

PARSIPPANY, N.J. — A subsidiary of Watson Pharmaceuticals is seeking approval for its version of an oral contraceptive from the Food and Drug Administration.

Watson Labs has filed an abbreviated new drug application with the FDA and is seeing to market drospirenone and ethinyl estradiol and levomefolate calcium tablets in the 3-mg/0.02-mg/0.451-mg strength and levomefolate calcium tablets in the 0.451-mg strength, a generic version of Bayer HealthCare Pharmaceuticals' Beyaz.

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday issued a public warning that the use of proton-pump inhibitors or H2 blockers may be associated with an increased risk of Clostridium difficile–associated diarrhea, or CDAD.

Patients should immediately contact their healthcare professional and seek care if they take PPIs and develop diarrhea that does not improve, the agency stated.

WASHINGTON — The generic drug industry's main lobby is hoping Congress will act on a proposed user fee program for generic drugs that it helped negotiate with the Food and Drug Administration.