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The Antihistamine Desloratadine (CLARINEX) - Son of Loratadine (CLARITIN)

Worst Pills, Best Pills Newsletter article March, 2002

By the time you read this, desloratadine (CLARINEX)—the Schering-Plough Corporation’s replacement for their $3 billion a year antihistamine loratadine (CLARITIN)—will be on pharmacy shelves. An army of sales people will be bribing your doctor with expensive meals, gifts, and vacations to switch your prescription from loratadine to desloratadine. Executives of your managed care organization or insurance company, depending on their concept of medical ethics, will be huddled in a back room with...

By the time you read this, desloratadine (CLARINEX)—the Schering-Plough Corporation’s replacement for their $3 billion a year antihistamine loratadine (CLARITIN)—will be on pharmacy shelves. An army of sales people will be bribing your doctor with expensive meals, gifts, and vacations to switch your prescription from loratadine to desloratadine. Executives of your managed care organization or insurance company, depending on their concept of medical ethics, will be huddled in a back room with Schering-Plough representatives negotiating for kickbacks, deep discounts or other favors, to make desloratadine the preferred antihistamine on their drug formularies.

Desloratadine is only technically a new drug. Patients who have been taking loratadine since it was approved in 1994 actually have been getting a dose of desloratadine because loratadine is broken down, or metabolized, to desloratadine in the body. Desloratadine is thereby produced as an active metabolite of loratadine.

Loratadine is due to lose its patent protection in December 2002 and Schering-Plough’s purpose in developing desloratadine can only be to protect its share of the brand name antihistamine market. It was certainly not to produce a safer or more effective antihistamine. The market for this drug alone accounts for about one-third of the company’s worldwide sales.

The market share protection scheme works like this. Loratadine has been Schering-Plough’s golden goose for years racking up tens of billions in sales, but loratadine is soon going to lose its patent protection. The question for the company was: how to protect loratadine’s market share to keep potential investors interested and current stock holders happy?

Schering-Plough used a simultaneous two pronged attack. First, they hired an army of Washington lobbyists spending millions trying to buy a three year patent extension for loratadine. When that failed, the company abused the intent of our patent laws to reward ingenuity and originality to get desloratadine, the metabolite of loratadine, protected and then got desloratadine past the Food and Drug Administration’s (FDA) outmoded 40 year old legal standard for marketing drugs, which does not require new drugs to be better than older ones.

Schering-Plough now has two antihistamines protected by patents—loratadine and desloratadine—that are inherently the same. With only 10 months left on loratadine’s patent, the goal is to switch as many patients as possible to the “new” desloratadine with its longer patent protection. This effectively extends Schering-Plough’s brand name monopoly in the antihistamine market for the life of the desloratadine patent and the company prays it will blunt generic competition to loratadine.

However, Schering-Plough has run into one very large hitch. There are no studies or data to show that loratadine and desloratadine are clinically different. And ethical managed care organizations and insurance companies are waking up to the fact that new drugs making it through the FDA’s drug approval process may be no more effective and can be less safe than drugs already on the market. Without evidence from head-to-head clinical trials testing a new drug against an old drug, ethical managed care organizations realize they would be buying a “pig in a poke.”

So, how does Schering-Plough plan to sell desloratadine when less expensive generic loratadine will be on the market in 10 months? Yet another tactic, other than those mentioned in the first paragraph of this article, is to offer desloratadine at a discount compared to loratadine. The wholesale list price for desloratadine has been announced at $1.83 per tablet, compared to $2.22 for loratadine, a difference of $0.39 per tablet.

A Wall Street analyst hit the nail on the head when he said “While the steep discount will mean less revenue growth for Schering in the short term, it will be beneficial over the longer term because it will speed up recruitment of Claritin [loratadine] users to Clarinex [desloratadine].” Put another way, in the long term consumers will have their pockets picked by Schering-Plough if they start using desloratadine.

Alas, the anarchy of the American “health care” system.

What You Can Do

There is no medical reason for you to be switched from loratadine to desloratadine. However, if you use desloratadine in the short term before generic loratadine is available you will save money. If you use desloratadine after generic loratadine is marketed you will be ripped-off.