FDA Rejects Otsuka Claims, Gives Go-Ahead to Generic Abilify

The FDA last week gave four drugmakers the green light to market generic versions of Otsuka’s blockbuster Tourette syndrome therapy Abilify, saying a labeling carveout would protect the brand maker’s pediatric exclusivity on the drug.

The approvals — for Alembic Pharmaceuticals, Hetero Labs, Teva and Torrent Pharmaceuticals — come just over a week after Abilify’s (aripiprazole) original exclusivity ran out on April 20 and cap off a bitter legal battle by Otsuka to block generic Abilify.

The FDA approved the drug for children with Tourette syndrome in mid-December, which granted Otsuka 10 years of orphan drug exclusivity. However, in February the agency expanded the indication to cover the general Tourette population, an indication Otsuka had not sought.

The drugmaker complained to the FDA, claiming it was inadvertently allowing a carveout for adult generic versions of the drug during the pediatric version’s exclusivity period. Otsuka also argued that the FDA’s actions violated the Orphan Drug Law, because orphan exclusivity bars all generic versions a drug for its approved indications.

Otsuka subsequently filed suit in federal court, leading a U.S. district court judge in Maryland to order the FDA to turn over all of its documents relating to the Abilify sNDA.

In an April 29 letter to Otsuka attorney Ralph Tyler, the FDA said the brand maker’s orphan exclusivity would remain protected because pediatric use would be carved out from the labeling on generic versions of Abilify. The agency notes that Abilify’s labeling includes no dosing information for Tourette in adults and that regulations permit generics to omit indications protected by exclusivity if the omission doesn’t lessen the drug’s safety or effectiveness for the nonprotected conditions.

While Otsuka Pharmaceuticals Co., Ltd. v. Sylvia Mathews Burwell et. al. is pending, it apparently isn’t stopping generics makers from marketing their drugs. Teva spokeswoman Denise Bradley tells DID that the company is launching 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg versions of Abilify immediately.

Otsuka did not respond to a request for comment by press time. Read the FDA’s letter at www.fdanews.com/04-28-15-Otsukaletter.pdf. — Lena Freund