Class Action Alleges AbbVie, Allergan, Forest Labs Blocked Generic Form of Bystolic Beta Blocker from Market

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A proposed antitrust class action alleges a host of major pharmaceutical companies unlawfully conspired to tamp down competition in the market for blockbuster prescription drug Bystolic, a beta-blocker used to treat high blood pressure. 

According to the 73-page lawsuit, AbbVie, Allergan, and Forest Laboratories, i.e. Bystolic’s manufacturers, worked together to prevent generic, more affordable versions of the drug from entering the market. 

“Potential new generic market entrants filed Abbreviated New Drug Applications … with the United States Food and Drug Administration … to manufacture, market and sell generic versions of Bystolic on December 17, 2011,” the complaint says. “Despite these ANDAs, no generic competitor has or will enter the market until September 17, 2021.” 

The case describes Bystolic as an important cardiovascular drug that blocks the hormone epinephrine—adrenaline—and causes the heart to beat slower and with less force, thereby lowering blood pressure. Whereas name brands of such a drug command top dollar on the market, “bioequivalent” generic versions can enter the U.S. market so long as they perform 99.8% the same as their name-brand counterpart, the suit explains.

Access to less expensive generic prescription drugs is crucial to society as they enable consumers and the health industry to save billions, the lawsuit stresses, noting generics “typically cost 50% less” than name-brand varieties while capturing 80 percent or more of the market share within the first six to nine months of their release.

Accordingly, name-brand “blockbuster” drugs tend to lose millions in sales each day as generics erode their market share due to the increasing dispensation of generics by pharmacists, according to the suit.

To avoid or delay these “market realities,” Forest Labs entered into a series of illegal reverse-payment agreements with potential generic competitors—including Hetero, Torrent, Alkem, Indchemie, Glenmark, Amerigen and Watson—by which the parties stipulated they would not compete with Forest or enter the market for Bystolic prior to September 17, 2021 unless another competitor took the plunge first, the lawsuit alleges. In exchange, Forest Labs offered “consideration” to the generic competitors via “side deals” and cash payments, according to the complaint.

Allergan and AbbVie have “perpetuated this illegal conduct” in the market for Bystolic, “all at the expense of consumers and health insurers,” the case alleges. 

Absent patent infringement lawsuits filed in December 2011 by Forest Labs and the 30-month stays triggered by law as a result of those actions, the defendants’ generic competitors would have been ready to bring their cheaper, already FDA-approved versions of Bystolic to the market “well before” September 17, 2021, the complaint claims. The case poses the litigation sparked by Forest Labs was “weak” and would have ended in favor of the generic competitors, which would have allowed the companies to launch their Bystolic counterparts.

Rather than face competition from the generic drug makers as early as July 2015 for Bystolic, and subsequent dips in sales and revenues, Forest Labs entered into “reverse-payment agreement[s]” with the companies, agreeing to share monopoly profits as incentive to stay clear of the market until September 2021, according to the complaint. 

“The result: the pharmaceutical companies won and health insurers and consumers, the intended victims of the anticompetitive scheme, were the biggest financial losers,” the contests. 

The suit looks to cover all persons and entities in the U.S. and its territories that indirectly bought, paid and/or provided reimbursement for some or all of the purchase price of Bystolic in any form, other than for resale, from June 2, 2015 “through and until the anticompetitive effects of Defendants’ unlawful conduct cease…" 

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