Otsuka Sues FDA, Wants Alkermes Rx Approval Yanked

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By Dana A. Elfin

Oct. 19 — Otsuka Pharmaceutical Co., the maker of the blockbuster schizophrenia treatment Abilify (aripiprazole), sued the FDA in federal court Oct. 15, asking a court to vacate and reverse the agency's recent approval of Aristada, a competitor to Otsuka's long-acting injectable formulation of aripiprazole.

In its complaint, filed in the U.S. District Court for the District of Columbia, the Japanese drugmaker claims the FDA's approval of Alkermes plc's Aristada (aripiprazole lauroxil), an extended-release injection to treat adults with schizophrenia, was arbitrary, capricious, and unlawful. It seeks to block the Food and Drug Administration from approving Aristada until Dec. 5, 2017, when the company's exclusivity rights on the product expire.

Approval Alleged to Violate Exclusivity Rights

Otuska alleges that the FDA’s approval of Aristada violates those exclusivity rights, rights that the FDA had granted to Abilify Maintena, Otsuka's long-acting injectable formulation of Abilify. Otsuka's three-year exclusivity for aripiprazole covers the use of aripiprazole to treat schizophrenia in acutely relapsed patients.

In addition, Otsuka's complaint says the FDA shouldn't have approved Aristada because it's not an innovative drug and doesn't represent a therapeutic advance or any new or additional therapeutic benefit over Abilify Maintena.

The FDA approved Dublin-based Alkermes's Aristada Oct. 5.

“[F]or all therapeutic purposes, aripiprazole lauroxil is aripiprazole,” Otsuka says in its complaint.

Otsuka claims the agency's reading of the federal Food Drug and Cosmetic Act is “unsound” and “allows for nonsubstantive, therapeutically meaningless, technical changes to already-approved drugs to undermine hard-earned statutory exclusivity for drugs that actually do make meaningful, substantive changes.”

FDA Taking Inconsistent Positions?

Otsuka claims that the FDA is trying to have its cake and eat it, too, when it comes to its approval of Aristada.

Otsuka says that while the agency determined that Abilify Maintena and Aristada are different for the purposes of exclusivity, it treated them as the same for purposes of approving Aristada's Alkermes 505(b)(2) new drug application.

The 505(b)(2) process is an abbreviated pathway that allows the FDA to rely on data not developed by the applicant for approval of a new drug application—in this case, on Otsuka's data. The FDA let Alkermes rely upon Otsuka’s aripiprazole safety and effectiveness data because aripiprazole is the same therapeutic agent used in both products, Otsuka said.

“[I]n a regulatory sleight of hand, FDA determined that Abilify Maintena and Aristada are different for purposes of exclusivity, but because aripiprazole is the only active therapeutic agent in both (i.e., the same), [the agency determined] that Aristada could rely upon Otsuka’s aripiprazole safety and effectiveness data,” the complaint says.

“FDA’s decision is fundamentally unfair and badly misconstrues the FDCA’s three year exclusivity statute,” the complaint says. “FDA’s decision allows Alkermes to obtain a Hatch-Waxman benefit (i.e., reliance on aripiprazole under 505(b)(2)), but not to be subject to the corresponding Hatch-Waxman tradeoff (i.e., subject to aripiprazole’s exclusivity).”

Alkermes Pledges to `Vigorously Defend Aristada.'

Meanwhile, Ireland-based Alkermes said Otsuka’s action is meritless. In an Oct. 15 8-K regulatory filing with the Securities & Exchange Commission, Alkermes, which has already launched Aristada, pledged to “vigorously defend Aristada” against Otsuka's attempts to get the drug's approval rescinded.

On Oct. 16, Alkermes filed an unopposed motion to intervene in the case. According to the docket, a status conference is scheduled for Oct. 26.

The case has been assigned to Judge Ketanji Brown Jackson.

Otsuka's Citizen Petition Shut Down 

Otsuka's lawsuit follows the FDA's denial of the company's citizen petition asking the agency to refuse to approve or delay approval of Aristada. The FDA approved Aristada and denied Otsuka's citizen petition the same day.

The agency said in its denial that the ingredient in Aristada is structurally different from the ingredient in Abilify and that the three-year exclusivity applicable to Abilify can't block Aristada's approval because Aristada contains a different active moiety than Abilify.

In another recent development related to Otsuka's efforts to protect its Abilify franchise, a federal court Oct. 13 dismissed the company's patent infringement claims against three generic drug companies over their generic versions of Abilify tablets. Otsuka is also facing claims that it engaged in sham judicial proceedings aimed at prolonging its monopoly in the aripiprazole market and to delay generic competition.

Ralph S. Tyler III, of Venable LLP in Baltimore represents Otsuka, a Japanese company with U.S. headquarters in Princeton, N.J.

Roger J. Gural, of the Department of Justice, represents the government.

William M. Jay, of Goodwin Procter LLP in Washington represents Alkermes Pharma Ireland Ltd. Of counsel are Christopher T. Holding and Sarah K. Frederick, of Goodwin Procter LLP in Boston.

To contact the reporter on this story: Dana A. Elfin in Washington at

To contact the editor responsible for this story: Brian Broderick at

A copy of the complaint is at

A copy of Alkermes' memorandum of law in support of its motion to intervene is at