Apotex

History

Apotex began with limited staff in a 10,000-square-foot warehouse. When Barry Sherman started Apotex, at first he was losing so much money "that his wife urged him to close his business before he lost everything." In 1980, Apotex was the first company to market a generic version of propranolol, the blood-pressure drug, which boosted Apotex's company profile.

By the mid-1990s, Apotex was earning $700 million in annual sales, which allowed it to control approximately 40 percent of the Canadian generic drug market. As an important development step, in 2003 Apotex became the first to market a generic version of Paxil, the antidepressant originally patented by GlaxoSmithKline. Apotex launched their generic version of Paxil "at risk", meaning before patent litigation between Apotex and GlaxoSmithKline over Paxil had concluded.

In 2007, Apotex acquired a Belgian generic drug maker, Topgen ESV, from Zambon Group SpA of Italy as a way for Apotex to expand its European footprint. That same year, Apotex acquired Lareq Pharma SL of Spain from Industria Quimica Y Farmaceutica to extend the company's presence in Western Europe. In 2010, Apotex launched a generic version of Pfizer Inc.'s cholesterol-lowering Lipitor drug in Canada, after four years of patent litigation with Pfizer. Apotex's generic version was launched under the name of Apo-Atorvastatin. This saved provincial health programs over $800 million per year.

In 2010, Apotex was listed in the eighth position in a report published by FiercePharma listing the top U.S. generic companies, based on sales from January 2009 to December 2009.

In 2012, Apotex launched a generic version of Crestor, the cardiovascular drug originally patented and manufactured by AstraZeneca. Apotex's generic version of Crestor is called Apo-Rosuvastatin.

On Friday, December 15, 2017, Apotex founder Barry Sherman and his wife Honey were discovered murdered at their home in North York. Toronto Police were still investigating as of June 2021 when the estate files were unsealed by order of the Supreme Court of Canada (SCC). "In June 2018, a lower court judge issued an order protecting the files, which concern the appointment of estate trustees and would ordinarily be available for public inspection."

Launch of first generic Plavix pill

In 2006, Sanofi-Aventis SA and Bristol-Myers Squibb Co., the producers and patent owners of Plavix, the blood thinner drug, settled a patent lawsuit with Apotex. In the settlement, Apotex agreed not to sell a generic version of Plavix until September 2011, in exchange for an unspecified amount of money. The settlement contained a clause that allowed Apotex to bring to market a generic version of Plavix in the situation where the agreement between Apotex and Bristol-Myers was not upheld by the U.S. Federal Trade Commission. In this situation, Apotex would be able to bring to market a generic version of Plavix, even before the expiration of Sanofi-Aventis SA and Bristol-Myers Squibb's patent on the drug.

In July 2006, the Attorney General rejected the agreement between Apotex and Sanofi-Aventis SA and Bristol-Myers Squibb Co. On August 8, 2006, Apotex launched their generic version of Plavix and during the five days that the company was able to produce the drug, Apotex "flooded the market with many months' supply of the generic drug."

A critical review of Miriam Shuchman's 2005 book about Dr. Nancy Olivieri versus Apotex, summarizes how "Nancy Olivieri is famous for raising doubts about an experimental drug with which she was treating thalassemia patients. Her principled stand, and the resulting scandal, led universities to offer researchers some protection against illegitimate drug company pressure. Medical journals changed their publication rules. Research hospitals changed their policies. She became an international icon. Apotex, the drug company which tried to silence her, has attracted international opprobrium. The company threatened to sue Olivieri if she publicly revealed her fears about the inadequacy of their drug, deferiprone. She sued them for libeling her; they sued her ($20 million) for libeling their drug."

Regulatory issues

Apotex received a warning letter from the FDA regarding its Etobicoke plant on June 25, 2009 for good manufacturing practice (GMP) violations. It also received a warning letter citing similar GMP violations in the Signet plant on March 29, 2010. The FDA issued an import ban on all drugs manufactured at these two plants and prevented the company from seeking new marketing authorizations in the US on August 28, 2009. The import ban was subsequently lifted on May 6, 2011. On February 29, 2012, Apotex filed a claim to the International Centre for Settlement of Investment Disputes seeking arbitration with the US. In the filing, Apotex cited unfair treatment by FDA which constituted a violation of the North American Free Trade Agreement (NAFTA). Apotex further claimed that the action of FDA 'decimated its business'. On August 26, 2014, NAFTA tribunal rejected Apotex's claim.

FDA inspected the same plants again in 2013 and issued warning letters for more problems.

In April 2014, FDA banned a manufacturing plant owned by Apotex in Bangalore, India. In the warning letter, FDA indicated that the plant routinely deleted failed test results and replaced with retest results that passed. FDA found that the violations are systemic and were dated back for many years, having the same issues noted in past inspections since 2006.

As of September, 2018 Apotex remains in violation of Current GMPs required by the FDA.

Price-fixing

In 2020, the US DOJ fined Apotex $24,100,000 for colluding with other pharmaceutical companies to price fix—raising costs of vital drugs for users who needed its cholesterol medicine. In the words of Special Agent in Charge Scott Pierce: "When generic drug companies conspire to fix prices and rig bids, they do so to the detriment of many who depend on these medications to maintain good health". In the words of U.S. Attorney William M. McSwain, "Compromising the health and welfare of innocent people by artificially inflating the price of a much needed medication is not only morally wrong, but illegal. Preying on the public in this manner for the sake of financial gain is something that must be rooted out of the pharmaceutical industry”.

On October 31, 2024, Apotex and Heritage Pharmaceuticals agreed to pay $49.1 million to resolve allegations of price-fixing in collusion to artificially raise drug prices as charged by a coalition of 50 U.S. state attorneys general.