Just hours after Bristol-Myers Squibb beat Wall Street expectations with earnings that got a goose from antipsychotic Abilify, the FDA opened the floodgates to generics of the blockbuster.
When you tot up the billions of sales at risk of patent expiration in 2015, the result is $44 billion, the biggest number since the debacle of 2012. But in 2015, generics are expected to take a much smaller bite from the drugs losing exclusive access to their respective markets. That's because several of the big expiries involve biotech drugs.
Otsuka's patent cliff is coming, with the expiration date on best-seller Abilify's IP shield just around the corner. But now, the Japanese pharma has signed a $3.5 billion agreement to pick up Avanir Pharmaceuticals that could help soften the blow.
What happens when the worst of the pharma patent cliff passes and new drug approvals surge? A big leap in drug spending. After a sluggish 5 years or so, global outlay on pharma products will jump by up to 30%--or $335 billion--by 2018, according to a new report from the IMS Institute of Healthcare Informatics.
A time-honored technique for boosting drug sales is simple: Raise prices. Lately, plenty of drugmakers pressed by patent-cliff losses have done just that. But some notable price hikes on diabetes drugs may be backfiring with payers. With diabetes costs taking double-digit increases--and expensive newer meds launching--insurers are tightening restrictions on drug use.
Forest will discontinue its original Namenda pill in August, pushing current patients onto Namenda XR--and hoping they won't bother to switch back when generics appear next April.
The antitrust crackdown in pharma has moved to Australia. Once again, Pfizer finds itself in the middle of a legal fight over its efforts to hang onto Lipitor sales after the drug went off patent and faced competition from cheaper generics.
After reports that cattle fed the growth supplement had problems walking or standing, Merck said it would temporarily suspend Zilmax sales in the U.S. and Canada to allow for an audit. The announcement followed Tyson's refusal last week to accept cattle treated with Zilmax.
Call it what you will: chutzpah, optimism, wishful thinking, spin-doctoring, or just plain confidence. In any case, the headline on Sanofi's earnings release--"Last Quarter with Significant Negative Impact from Patent Cliff"--was one of the few positive statements on the page.
U.S. drug spending dropped last year. While that may be welcome news for healthcare budgets, it's not so good for branded drugmakers. It may not be so good for patients, either.