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Feb. 3 — Depomed Inc. is petitioning the FDA to stay final approval of generic applications for the extended-release opioid pain medication Nucynta ER (tapentadol), because the drug now has an expanded use code.
In a citizen petition posted to the regulations.gov website Feb. 1, Depomed asked the Food and Drug Administration to delay granting final approval for any abbreviated new drug applications (ANDAs) that fail to submit a patent certification for U.S. Patent No. 8,536,130 (the '130 patent) containing the updated use code for that patent. The name of that patent is “Use of 1 phenyl-3-dimethylamino-propane compounds for treating neuropathic pain.”
The Depomed petition said that for method of use patents, the new drug application holder is required to identify the patent claims that “read on the label” and to provide a use code that describes the label language that would infringe those claims.
According to the petition, dated Jan. 29, the expanded use code for one of the patents covering Nucynta now encompasses both of the drug's FDA-approved indications, meaning that generic applicants won't be able to carve out one of the drug's indications from the approved labeling.
Depomed’s update to the patent's use code means that any generic applications that attempt to carve out one of the labeled indications for Nucynta ER will overlap the new use code and infringe the patent, the company said.
If the FDA grants Depomed's petition, it means that any generic applicants that sought to omit one of the indications will instead have to either challenge the patent's validity and enforceability or wait for the patent to expire.
Depomed told the agency that if it doesn't grant its petition, generics could launch with labels that violate federal food and drug law.
Absent the FDA granting the petition, Depomed said the agency could approve one or more of the pending generic applications without the required certification for the '130 patent and “with labels that are in violation of the sameness requirement.”
Under FDA rules, final approval cannot be granted for any ANDA that is not in compliance with patent certification and labeling sameness requirements, Depomed said.
The '130 patent is listed in the Orange Book (formally titled “Approved Drug Products with Pharmaceutical Equivalence Evaluations”). According to the Orange Book, the '130 patent doesn't expire until Sept. 22, 2028. Meanwhile, the compound patent on the drug is scheduled to expire June 6, 2017.
The Orange Book is a listing of patents that innovator drug companies claim cover their drug products.
Generic applicants could launch their generic versions of Nucynta ER “at-risk”—that is, before the patent litigation over the branded drug is resolved.
The generics would face damages if the patents are later found to be valid and enforceable.
Nucynta ER is approved for two indications: (1) the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate; and (2) the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
According to the petition, shortly after Depomed purchased the Nucynta ER franchise from Johnson & Johnson (J&J) in March 2015, the company reviewed the patents on the drug and discovered that the '130 patent claims were “actually much broader than what was reflected in the use code then on file in the Orange Book.”
To accurately reflect the scope of the patent claims, Depomed subsequently amended the use code listed for the '130 patent.
“[T]hus, any pending ANDA applications containing a section viii statement must be withdrawn or amended and an appropriate patent certification filed for the '130 patent,” the petition said.
Generic applicants seeking FDA approval to market products before the patents on the drug expire can file section viii statement seeking to omit or carve out the patented use from its label.
As of December 2015, Depomed said it was aware of three ANDAs referencing Nucynta ER, one of which has received tentative approval. Two of those applicants have submitted section viii carve-out statements and one has filed a Paragraph IV certification and notice for the '130 patent (which challenges the patent), Depomed said.
Depomed said it has sued the three applicants for patent infringement and the statutory 30-month stay on generic approval is to expire on May 20. According to information in federal court dockets, those generic applicants include Actavis Elizabeth LLC, Alkem Laboratories LLC and Roxane Laboratories Inc.
Depomed is the exclusive licensee of the '130 patent. German company Grunenthal GmbH is the patent holder of the '130 patent.
Depomed is based in Newark, Calif. Terry G. Mahn of Fish & Richardson P.C. in Washington submitted the petition on behalf of Depomed.
To contact the reporter on this story: Dana A. Elfin in Washington at email@example.com
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The citizen petition is at http://src.bna.com/co9.
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