Drugs

Depomed Wants Nucynta ER ANDAs Changed

Depomed is petitioning FDA to delay granting final approval to ANDAs citing Nucynta ER (tapentadol) as the reference-listed drug until the sponsors submit a revised patent certification for the ’130 patent as it is currently listed in the Orange Book. The petition calls on the agency to delay granting final approval of ANDAs with a section viii statement relating to the ’130 patent until the applicants comply with FDA rules by:
amending or withdrawing their section viii statements in response to the amended ’130 patent use code; submitting a relevant patent certification for the ’130 patent; providing the required notice of any Paragraph 4 certification submitted; and updating their labels, as needed, to conform with the amended use code.

Depomed says that it purchased the Nucynta ER franchise from Johnson & Johnson in 2015 and became aware that the ’130 patent claims were much broader than what was reflected in the use code on file in the Orange Book. Thus, it says, the company amended the use code for the patent to accurately reflect the scope of the patent claims.

“The amended use code now completely ‘overlaps’ both of the labeled indications for Nucynta ER; thus any pending ANDA applications containing a section viii certification statement must be withdrawn or amended and an appropriate patent certification filed for the ’130 patent,” Depomed says. “Under FDA rules, final approval cannot be granted for any ANDA that is not in compliance with patent certification and labeling sameness requirements.”

The petition argues that with the update to the patent code, a section viii statement is no longer appropriate as any carve out will require the removal of both labeled indications for Nucynta ER and anything less will overlap the new use code and infringe the patent. Therefore, it says, ANDA applicants with section viii statements must amend their applications to address the new use code as required by FDA regulations.

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