Updated: Copaxone Generics: Who Will Win First Filer Exclusivity?

Posted 04 October 2017 By Zachary Brennan

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Generic versions of Teva's multi-billion-dollar per year multiple sclerosis drug Copaxone (glatiramer) have arrived, but a closer look at which competitor might win the coveted 180-day exclusivity reveals an unusual and complex situation.

Back in January, a US District Court for the District of Delaware ruling invalidated all asserted claims on Teva's patents on its 40 mg version of Copaxone, opening the door for generic competitors.

Late Tuesday, Mylan announced FDA's approval of its 40 mg generic version of Copaxone, which is the first approval, as well as its 20 mg version. Mylan said it and other first filers may be eligible for the 180 days of generic drug exclusivity but FDA "has not made a formal determination on exclusivity at this time."

Meanwhile, Sandoz and Momenta's 40 mg generic Copaxone (their 20 mg version first won FDA approval in April 2015) has been delayed due to manufacturing issues at a Kansas-based site, though they may still end up sharing exclusivity with Mylan.

Momenta has also said that the FDA warning letter does not restrict the production or shipment of the 20 mg version, known as Glatopa, which is currently marketed by Sandoz and for 2016, recorded $74.6 million in product revenues.

A total of four generic companies – Momenta, Synthon, Mylan and Dr. Reddy's – have filed for approval of their copycat versions of Copaxone days after the brand name 40 mg version was approved 28 January 2014, and all four claimed the status of first-filer, though it's unclear which one actually filed first, Ronny Gal, analyst at Bernstein, explained in a note to investors in May.

The generic companies, which all had previously filed other abbreviated new drug applications (ANDAs) on a different version of Copaxone, then, according to Gal, "presumably all amended their applications to include a paragraph IV that day" the 40 mg version of Copaxone was approved, which is standard practice when new patents are listed in FDA's Orange Book.

Teva, meanwhile, anticipating the early filings while wanting to delay lawsuits and competition, according to Gal, "took the maximum time allowed before filing their patents in the Orange Book" on 26 February 2014. Teva also attempted to delay generics by filing FDA citizen petitions that were later rejected.

But Gal says that under his reading of the law, the Medicare Prescription Drug, Improvement, and Modernization Act, each company that certified its ANDA as paragraph IV on the date the patent lists will share the exclusivity. So even if a company filed an original ANDA for Copaxone "one or two days late," the companies that amended their filing to include a paragraph IV certification on 26 February likely will share exclusivity.

"For a complex ANDA like Copaxone where companies may have used different approaches to show bioequivalence or at least presented their data in different formats, it is quite possible that the timelines to affirm completeness [from FDA] varied significantly," Gal noted. "In fact, all the companies who filed ANDA against Copaxone in January notified Teva of their filing only during the summer, suggesting lengthy pre-acceptance FDA reviews (Dr. Reddy on Aug 1, 2016, Sandoz/Momenta on Aug 28, 2014, Mylan/Natco on Aug 29, 2014, and Synthon on Oct 8, 2014)," Gal noted.

There also has been speculation that the date in which Teva filed lawsuits against the generic companies correspond to the order of the filing, but Gal says he does "not believe this is the case."

Editor's Note: This story, originally published in May, has been updated on 10/4/17 with the note on Mylan's approval.

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Categories: Generic drugs, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA

Tags: Copaxone, Teva, Mylan, Momenta, Synthon, Dr. Reddy's

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