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Atorvastatin is a statin medication used to lower cholesterol levels in the blood. It was originally developed by Pfizer and is commonly sold under the brand name Lipitor. Here is a brief overview of its life cycle.
Drug Discovery: Atorvastatin, then codenamed CI 981, was first synthesized by Warner-Lambert chemist Bruce Roth in August 1985. Initially Warner-Lambert management were reluctant to advance candidate CI 981 into clinical trials reasoning that by its chemical structure it was a me-too version of the rival Merck & Co.’s orphan drug lovastatin (brand name Mevacor). Mevacor, was first marketed in 1987, was the industry’s first statin and meanwhile Merck’s synthetic version – simvastatin – was already in the advanced stages of development. Despite these reservations, Bruce Roth and his company superiors convinced the Merck executives in 1985 to advance the compound into costly clinical trials.
Development, Approval, Business Acquisition & Sales: In the late 1980s, Atorvastatin went through rigorous clinical trials to demonstrate its safety and efficacy in reducing cholesterol levels. Early clinical trial data comparing atorvastatin to simvastatin demonstrated that atorvastatin appeared more potent and with fewer side effects. It received approval from regulatory authorities in various countries, including the U.S. Food and Drug Administration (FDA) in 1996. In the same year, Warner-Lambert entered into a co-marketing agreement with Pfizer to sell Lipitor, and then in 2000 for $US90.2 billion, Pfizer acquired Warner-Lambert. By 2003, Lipitor had become the top selling pharmaceutical in the US.
Patent Expiry & Brand Loyalty: Like many other medications, Atorvastatin had a patent protection period, which granted Pfizer exclusive rights to manufacture and sell the drug. The patent for Lipitor expired in the US at the end of November 2011 with various countries following suit at different times thereafter, allowing other pharmaceutical companies to produce generic versions of Atorvastatin. Meanwhile in Europe, Pfizer managed to extend the drug’s patent protection by six months to May 2012, with the announcement of new paediatric data which enabled Pfizer to launch of a chewable grape-flavoured version of Lipitor for hyperlipidemic children in the European market. With the patent expiry looming, Pfizer had already initiated a series of marketing ploys aimed at encouraging prescribers and patients to continue using its own brand. The company managed to sign up to a series of discounting deals with pharmacy benefit managers and health insurers, as well as agreements for pharmacies to substitute credit for generic atorvastatin with discounted Lipitor, according to advocacy group Pharmacists United for Truth and Transparency. Pfizer had also taken the unconventional initiative of setting up its own mail-order service to supply Lipitor, targeting patients who have been taking Lipitor for years and who would been reluctant to switch to a different generic version. This was unprecedented for a pharmaceutical company to exploit the elements of brand loyalty and emotional attachment in their marketing ploys. Usually, pharma companies compete with one another based on clinical and product-related features and price. Brand loyalty does play a key role with over-the-counter (OTC) medicines; however, Pfizer was able to use its Lipitor brand at the time as a competitive advantage as a new defensive strategy against their generic rivals.
Generic Availability: After full patent expiration of Atorvastatin worldwide, numerous generic versions of the medicine became available in the market. Generic medications are equivalent in active ingredients and effectiveness but are typically more affordable than brand-name drugs. On the day of the US patent expiry, a licensed generic version of atorvastatin from Watson Pharmaceuticals was released on the US market. While Ranbaxy Laboratories, which had first-to-file, six-month exclusivity for generic atorvastatin in the US were under the scrutiny of the FDA relating to manufacturing compliance. Almost a year later after the US patent expiry of Lipitor, Ranbaxy halted production and recalled 41 lots of atorvastatin due to glass contaminant being discovered in some of its samples. In the same year, an apparent dosage mistake was found in which 20 mg tablets were discovered in a 10mg labelled bottle of atorvastatin tablets; this culminated in the voluntary recall of roughly 64,000 bottles in the US in 2014. Prices for the generic version of Lipitor did not drop to the level of other generics; a month supply for $US10 or less a packet at the time, until other manufacturers began to supply the medication in May 2012.
Market Dominance: Lipitor was one of the best-selling drugs globally during its patent-protected period. From 1996 to 2012, under the brand name of Lipitor, atorvastatin became the world’s best-selling prescription medicine of all time, with more than $US125 billion in sales over roughly a timeframe of 14.5 years. Global Lipitor sales reached its peak in 2006, at almost $US13 billion, with just over 60% of those sales coming from the U.S. After its patent expired, generic Atorvastatin became widely available, leading to a decrease in the market share of the brand-name product.
Continued Use Abroad: After Lipitor’s patent lapsed in late 2011, sales started declining drastically in the US as numerous generic atorvastatin pills were released into the market. However, since 2014, annual sales have hovered around the $US1 to 2 billion mark thanks to the huge size of the Chinese market. In recent years, Pfizer had managed to secure bids to sell Lipitor in Chinese hospitals, “as they could more easily offer quality assurances for their higher-cost medicines,” according to Bloomberg at the time. By 2018 Pfizer had grown a strong market share for Lipitor in China and having a presence beyond the major cities, enabled them to supply 74 per cent of atorvastatin to Chinese hospitals according to Chinese bank Bocom International. However, after losing a large hospital bid in the same year, Pfizer lowered Lipitor’s price in China by 30% “in the hope patients would buy it privately,” the Financial Times reported in 2019. Nowadays Lipitor is mostly bought overseas but holds a small stake in its domestic US market.
Present Day Landscape: In 2017, Lipitor generated $US1.92 billion per year in sales for Pfizer, even though its patent had expired six years prior. By 2020 Lipitor failed to even be included in the top 20 of best-selling prescription medicines worldwide attributable to the generic competition. Virtually most of Pfizer’s Lipitor sales now come from China and other emerging markets. However, Lipitor’s ability to remain a “cash cow” drug, despite so many generic competitors setting their price as low as a few cents per pill reveals elements of economic unfairness in the global pharmaceutical market. Nowadays there are numerous brand names which atorvastatin is sold by generic medication including Atoris, Atorlip, Atorva, Atorvastatin Teva, Atorvastatina Parke-Davis, Avas, Cardyl, Liprimar, Litorva, Mactor, Orbeos, Prevencor, Sortis, Stator, Tahor, Torid, Torvacard, Torvast, Totalip, Tulip, Xarator, with even Pfizer competing in the generics market with its own generic version under the name Zarator.
Forecasted Sales Share: The brand Lipitor is predicted of all prescription medicines, to reach the third highest lifetime sales by 2026. Until 2021, the Lipitor’s cumulative lifetime sales exceeded $US163 billion which is forecasted to increase by another $US5.5 billion up to 2026.
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