Impax confirms patent challenge for generic Jalyn
HAYWARD, Calif. — Impax Labs has hit a roadblock in its attempt to market a generic version of a symptomatic benign prostatic hyperplasia drug.
The generic drug maker said that GlaxoSmithKline filed a patent infringement suit against Impax in the District of Delaware last week in connection with its attempt to market dutasteride and tamsulosin hydrochloride 0.5 mg/0.4 mg capsules, a generic version of Jalyn. The suit was filed after Impax submitted an abbreviated new drug application containing a paragraph IV certification for the drug with the Food and Drug Administration.
Once the ANDA is approved by the FDA, Impax’s generic division intends to commercialize the product.
Jalyn, designed to treat symptomatic BPH in men with an enlarged prostate, garnered U.S. sales of about $41 million for the 12-month period ended in July, according to Wolters Kluwer Health data.
Retail fraud incidence down, but dollar impact escalating
NEW YORK — For every $100 in fraudulent transactions, retailers incurred a “true” cost of $230, according to a new study released Tuesday by LexisNexis Risk Solutions.
According to the study, retail merchants and financial institutions reported an overall decline in fraud rates and transactions while total retail sales rose. Consumers also experienced a decline in fraud losses overall but the average time it took to resolve fraud issues rose by 57% and the out-of-pocket costs of fraud rose by $244.
However, fraud rates could be poised for an upswing. The number of fraudulent transactions has decreased, but the average dollar value of a completed fraudulent transaction is higher than last year, indicating the nature of transactions is becoming more severe. While on average, retail merchants report paying less per dollar for fraud than they were in 2010, small merchants and certain industries continue to report high out-of-pocket costs. E-commerce and mobile merchants are combating an influx of fraudulent transactions which tend to be large in dollar amount.
“It is true there has been industry progress in fraud mitigation, however fraud continues to cost retail merchants over $100 billion annually and consumers are feeling the increased affects of fraud,” stated Jim Rice, director of market planning for retail and e-commerce markets at LexisNexis Risk Solutions. “While e-commerce, mobile payments and international commerce provide the retail industry with the most growth opportunities, they also present the greatest challenge to fraud prevention.”
The study was conducted through an online survey completed by a merchant panel comprised of 1,006 risk and fraud decision-makers and influencers. The panel represents all company sizes, retail segments, channels and payment methods. A number of interviews also were completed with risk, fraud and financial institution executives. Finally, the study leveraged identity fraud victim data from a survey of 5,000-plus U.S. adults, including 466 fraud victims, representative of age, gender, income, and ethnicity to determine the consumer costs resulting from fraud. The full report is available here.
LexisNexis also is hosting a free webinar Sept. 14 at noon to discuss findings. To register, click here.
Watson launches generic Keppra XR
MORRISTOWN, N.J. — Watson Labs has begun shipping a drug designed to treat partial onset seizures in patients with epilepsy.
The drug maker said it launched levetiracetam extended-release tablets in the 500-mg and 750-mg strengths. The drug is a generic version of UCB’s Keppra XR. The drug is indicated to treat patients ages 16 years and older.
Watson said it began shipping the drug on Tuesday following approval of its abbreviated new drug application from the Food and Drug Administration.