A few days ago, foreign media reported that according to the latest class-action lawsuit, the patent agreement reached between Takeda and Endo’s Par Pharmaceuticals delayed the launch of Takeda’s constipation drug Amitiza generic drug, suspected of violating the antitrust law, causing The patient's medical expenses exceeded hundreds of millions of yuan.

For many years, brand-name drugmakers have been reconciling with generic drug companies to expand and extend market exclusivity. These "deferred payment" transactions are often criticized for violating the principle of fair competition. Now Japanese pharmaceutical giants Takeda and Endo are facing scrutiny because they have reached a settlement agreement for generic drugs in advance.

The plaintiff claimed in the Federal Court of Massachusetts in the United States that the transaction allowed the two companies to "maintain their monopoly on Amitiza" and effectively delayed the competition for the generic drug for several years. The lawsuit claims that the two companies have made "hundreds of millions of dollars" in profits during this period, and because there is no impact from generic drugs, the price of the drug has been high, and the amount that patients spend on this is "much higher" than they should have paid. cost of.

Previously, Takeda obtained the commercial rights to Amitiza through a license agreement with Sucampo Pharmaceuticals, which is now part of Mallinckrodt Pharmaceuticals. At the end of 2012, PAR reminded Sucampo that the company was seeking FDA approval for a generic drug of Amitiza and hoped to market the generic drug after a key patent for the drug expired in 2014.

At that time, Takeda quickly filed a lawsuit against the generic drug company, accusing it of infringement of 6 patents of the original drug. In the end, the two companies reached a settlement agreement in the fall of 2014. PAR promised to postpone the sale of its own-made Amitiza generic drugs, or to use authorized generic products provided by Takeda, and the date of the agreement will be maintained until 2021. PAR also agreed to pay Takeda the royalties incurred from the sales of its generic drugs.

According to FDA regulations, the first company to apply for a generic generic drug has six months of exclusivity. During this period, other generic companies are not allowed to enter the market. Based on the previous settlement, PAR is already the first manufacturer of generic drugs. Subsequently, Takeda has reached a separate settlement agreement with several other manufacturers of Amitiza generic drugs to further postpone the release of Amitiza generic drugs until 2023.

Although Amitiza is not the best-selling drug in the industry, the drug has always been an important asset of Takeda. In the fiscal year ending in March this year, Takeda reported Amitiza sales of 21.2 billion yen (approximately 191 million U.S. dollars), a decrease of approximately 25% from the previous year's 28.1 billion yen (approximately 253 million U.S. dollars).

In recent years, it is not uncommon for major pharmaceutical companies to make settlement payments for the postponement of the listing of generic drugs, and they have gradually attracted the attention of regulatory authorities. In 2019, California became the first US state to ban such commercial operations. According to an estimate by the U.S. Federal Trade Commission (FTC), such transactions result in approximately $3.5 billion in overspending on medicines each year.

In addition, the US Federal Trade Commission is suing Endo for another deferred payment agreement. The antitrust agency stated that Endo violated the antitrust law and reached a similar profit-sharing agreement with Impax Laboratories in 2017, which resulted in the suspension of the listing of the generic drug Opana ER, an analgesic it developed.