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Patent Expires On Best Selling Drug of All Time
Hugh Pickens writes "The U.S. patent has just expired on Lipitor, the best-selling drug of all time, as the first generic versions go on sale, marking the end of a brand that has dominated the drug industry, lowered the cholesterol of tens of millions of patients, and generated $10.7 billion last year in annual sales. But drug manufacturer Pfizer, dependent on Lipitor for almost one-fifth of the company's revenue, does not intend to go down without a fight. Pfizer is employing unprecedented tactics to hold onto as many Lipitor prescriptions as it can with an aggressive marketing plan and forging deals with insurers, pharmacy benefit managers and patients to meet or beat the price of its generic replacements because even at the lower price, Pfizer has a huge profit margin because of the relatively low cost of materials for Lipitor. Some deals require pharmacies to reject prescriptions for low-cost generics and substitute a discounted name-brand Lipitor while other deals block generic makers from mail-order services that account for an estimated 40 percent of all Lipitor prescriptions. 'Pfizer's tactic of dressing up as a generics company is pulling the rug under the incentive system created to foster the development of generic drugs,' says attorney David A. Balto."
Phizer was able to extend the drug by getting new patents on it. Then for these past few months they paid off the generic drug makers to not create generics for the drug. A scheme known as "pay for delay". Heard about it yesterday on Marketplace and was shocked to hear that a generic drug company has to go to court after the patent has expried to official unexpire it. "This is the government policy, set up in the 1980s, to bring us lower drug prices." http://www.marketplace.org/topics/business/lipitor-makes-way-generics
This bears only the most tenuous connection to the truth. Yes, the cholesterol synthesis pathway came out of a lot of university research. HMG-CoA reductase is a critical enzyme. There are a lot of compounds that will inhibit enzymes in vitro; the vast majority are utterly unsuited to use as anything but research compounds because they aren't safe, can't be made into an orally bioavailable form, have bad kinetics, or any of a thousand other things that can sink a potential drug.
Drugs come from... drug companies, not from universities, because drug companies have the billions of dollars to put a compound through clinical trials and the expertise to make the drugs usable.
If they want to outbid generics on price, nothing's wrong with that. But those agreements mentioned in TFS, where pharmacies must only prescribe their offering - that sounds rather anti-competitive to me.
Yep. The first one that comes to mind is claritin.
From what I remember, claritin is a... prodrug? - it metabolises to something else in vivo. So when they patent expired, they started marketing the metabolite instead, which they got a new patent on.
I've heard of other cases where drugs, previously a mix of L and R isomers became generic, so they launched a new drug with just one of the isomers.
Kind of nauseating, really.
Loratadine was eventually approved by the FDA in 1993.[2] It accounted for 28% of Schering's total sales[citation needed]. The drug continued to be available only by prescription in the U.S. until it went off patent in 2002.[citation needed] It was then immediately approved for over-the-counter sales. Once it became an unpatented over-the-counter drug, the price dropped precipitously, and insurance companies no longer paid for it. In response, Schering launched an expensive advertising campaign to convince users to switch to desloratadine (descarboethoxyloratadine, trade name Clarinex), which is the active metabolite of loratadine. A 2003 study comparing the two drugs found that "There is no clinical advantage to switching a patient from loratadine to desloratadine.
Sent from my PDP-11
Nope. Drug targets come out of universities. But drug targets are a dime a dozen. The real expense is in clinical trials, and that is paid by drug companies in almost all cases. When the cost is shared the university gets part of the patent.
- Pennsylvania, for instance.
"National Security is the chief cause of national insecurity." - Celine's First Law
Pfizer did not discover or invent Lipitor. Lipitor was discovered and invented by Warner Lambert/Parke-Davis in Ann Arbor, Michigan, in an industrial setting, not academic. Warner Lambert/Parke-Davis partnered with Pfizer to develop and market the drug and share the profits. From the profits of Lipitor alone, Pfizer was able to buy and takeover Warner Lambert/Parke-Davis, where it closed the Ann Arbor site a few years later in 2007 (http://www.youtube.com/watch?v=02krhNFfEq4). Of the 2200 scientists at the Ann Arbor site, approximately 600 remained with the company, of which approximately 300 relocated to Groton, CT, Pfizer's legacy discovery research site. The other 300 scientists relocated to sites in St. Louis, MO (winding down and eventually closing), La Jolla, CA, and Sandwich, England (now in the process of closing - over 2000 jobs lost). In these relocations, Pfizer was very generous and bought families homes for the original price and paid to relocate employees and their families across the world. Pharmaceutical site closures are very expensive and impact families and disrupt local economies significantly; purchasing employees homes is an incentive to retain talent. Pfizer assisted employees buy new homes by paying for real estate agents and paying closing costs on homes. In 2009, Pfizer bought Wyeth Laboratories and laid-off tens-of-thousands of scientists, many of them from Ann Arbor, MI, its most successful discovery research site ever based on the site talent, technology, and number of marketed drugs from that site, Groton, CT, and many from Wyeth various sites in the U.S. Several years ago, Pfizer was able to reduce the cost of manufacture of Lipitor more than 200-fold using a series of natural wildtype and industrially modified enzymes.
Pfizer's former CEO Jeffrey B. Kindler and former CEO of McDonalds, became so unpopular with the rank-and-file that he earned two nick-names, first "McBurger," and finally and more commonly known as "CLOWN SHOES" (http://www.youtube.com/watch?v=clgRId8x0ZM). Employees would and still post about dissatisfaction with the company's direction and leadership on BioFind.com (http://biofind.com/rumor).
In the early 1900s, nobody had NMR, IR, or mass spectrometry to determine structures and reproduce them. And we really had very few drugs - if you study the development of clinically useful drugs, modern mechanisms of action mostly didn't appear until the amphetamines of the 1920s, and penicillin and the antihistamines in the 1930s.
Lipitor has had an ANDA filed for a generic version by Watson, yes. However, the law allows Pfizer to grant a 180 day exclusivity contract to a manufacturer of their choice (in this case Watson) for the ANDA. To those affected by this drug going generic: IT HAS NOT GONE TRULY GENERIC YET! Wait until the 180 day exclusivity contract expires (in 179 days) and the true "invisible hand" will take effect in the market.
In the meantime, you're most likely going to need to get the BRAND NAME Lipitor for it to be covered to the fullest extent by your pharmacy benefit manager ("insurance company")! These PBMs get rebates (NOT kickbacks) to lower the cost of the brand-name drug, so it's financially advantageous to the member to not cover the generic yet. Here's why:
Lipitor (brand) 90ct bottle = $550 retail, minus $330 in rebates = $220 total cost of drug.
atorvastatin by Watson (generic) 90ct bottle = $530 retail, minus $0 in rebates (Watson doesn't offer any) = $550 total cost of drug.
(These amounts are fictional, however they represent true real-world scenarios.)
Disclaimer: I work for one of the US' largest Pharmacy Benefit Managers in the Clinical Review department. We had a meeting today regarding all of our Medicare Part-D patients and how they're affected by this specific drug going generic. No suits were involved and the members are receiving the best possible drug savings until the exclusivity contract expires. Once it expires the new generics will be placed on the tier-1 ("generic") copay structure.
I don't have the slightest clue as to why you're modded at +5, but I do know that you have literally no clue as to what in the hell you're talking about. I assume you're referring to the anti HPV vaccine Cevarix rather than Gardasil because you mention "the Australian taxpayer" and some of the technology used in Cevarix was discovered at Uni. Queensland. You conveniently neglect to mention that the Queensland researchers were collaborating with others at Georgetown, the Uni. of Rochester and the US National Cancer Institute, among others. The technology behind the discoveries made at these places was licensed to GlaxoSmithKline, a British company. The idea that the Australian taxpayer footed the bill for the FDA trials in the US is, frankly, idiotic. The trials were conducted by Glaxo, obviously. Additionally, there is no "US drug company that licenced [sic] it", it's being sold by Glaxo here just as it is everywhere else.
I know it's a crying shame that none of this fits into your wacky worldview where all corporations represent the nexus of evil and steal all their product ideas from "the people", but I guess you'll just have to find some way to get over it. I suggest you take some of your own advice about "paying more attention before writing" before your next post.
- "Hear that?! The percolations are imminent! Cease your ingress!"