Patent Baristas

A panel of experts put together by the U.S. Food and Drug Administration looked at the safety concerns surrounding the more than $5 billion drug-coated stent industry. These so-called drug-eluting stents are small metal tubes implanted into blood vessels to help prop up clogged heart arteries after they have been cleared. By coating the stents […]

Ranbaxy and Teva won a victory in the U.S. Court of Appeals for the D.C. Circuit that preserved their 180-day exclusivity when patents are delisted from the FDA Orange Book. Ranbaxy et al. v. Michael O. Leavitt, Secretary of Health and Human Services et al. (06-5154). Ranbaxy and Teva had challenged the decision on the […]

Legislators are stepping up the pressure in the long running saga of getting generic versions of biotech drugs to market. The FDA approves generic versions of pharmaceutical (small molecule) drugs once the patents for brand-name products expire. But complex biotech drugs do not have such an approval process. Representative Henry Waxman and Senator Orrin Hatch […]

AstraZeneca filed a request for an advisory opinion from the FDA pursuant to 21 C.F.R, § 10.85, asking whether patents directed to drug delivery systems, such as inhalation devices, that do not recite the approved active ingredient or formulation should be listed in the “Approved Drug Products With Therapeutic Equivalence Evaluations” (“Orange Book“). 21 C.F.R. […]

A pharmacies’ right to compound prescriptions came in jeopardy after the Food and Drug Administration argued that compounding creates new and unapproved drugs. In Medical Center Pharmacy, et al. v. Gonzalez, et al., No. MO-04-CV-130, District Court for the Western District of Texas, a suit was brought by 10 pharmacies against the Food and Drug […]

If you’re familiar with the drug industry, it should come as no great shock that the Generic Pharmaceutical Association (GPhA) disagrees with a report put out by the Pharmaceutical Research and Manufacturers of America (PhRMA). According to a recent report commissioned by the Pharmaceutical Research and Manufacturers of America (PhRMA), wholesale price discounts off brand […]

Without going into how much fun it is to look like a geriatric smoker walking around with an attractive nose cannula, there seems to be more and more interest in breathing in oxygen (at least air that has more oxygen than normal). There was even an oxygen bar at BIO this year. Now, the air […]

Merck is on the verge of losing patent protection for its multi-million dollar drug compound Simvastatin, paving the way for euphoric generic players to enter the U.S. Simvastatin market, which was worth around U.S. $4.4 Billion worldwide in 2005. Even though there is no current Para IV litigation for the Simvastatin tablet, the story so […]