The future of generic Copaxone?

A post concerning future generic "Copaxone" at raps.org begins


Generic versions of Teva's multi-billion-dollar per year multiple sclerosis drug Copaxone (glatiramer) are coming, but a closer look at which competitor might win the coveted 180-day exclusivity for its generic 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 40mg version of Copaxone, opening the door for generic competitors.


Link: http://raps.org/Regulatory-Focus/News/2017/05/25/27667/Copaxone-Generics-Who-Will-Win-First-Filer-Exclusivity/#sthash.7P2SLVjY.dpuf

From a press release on 30 January 2017:


Teva Pharmaceutical Industries Ltd. today [30 January 2017] confirmed the U.S. District Court for the District of Delaware ruling invalidating all asserted claims of the ‘250, ‘413, ‘776 and ‘302 patents for COPAXONE® (glatiramer acetate injection) 40 mg/mL. The patent infringement case involved five of six Abbreviated New Drug Application (ANDA) filers. Teva plans to appeal the decision.

“We intend to move forward with an immediate appeal,” said Erez Vigodman, Teva President and CEO. “We will continue to vigorously protect our COPAXONE® franchise against further challenges and through the duration of this process.”

Separately, a suit was filed against all six ANDA filers on December 19, 2016 in the U.S. District Court for the District of Delaware to assert a fifth Orange Book patent, U.S. Patent 9,402,874. Additionally, Teva has brought suit against multiple ANDA filers to assert a non-Orange Book process patent, U.S. Patent No. 9,155,775, in various jurisdictions.



In passing, by the time of the Supreme Court decision in Teva/Sandoz, all claims in the contested cases had expired except for those of US 5,800,808, which single claim recited:

A method of manufacturing copolymer-1, comprising reacting protected copolymer-1 with hydrobromic acid to form trifluoroacetyl copolymer-1, treating said trifluoroacetyl copolymer-1 with aqueous piperidine solution to form copolymer-1, and purifying said copolymer-1, to result in copolymer-1 having a molecular weight of about 5 to 9 kilodaltons.

See also: TEVA PHARMACEUTICALS USA, INC. v. Sandoz, Inc., 749 F. Supp. 2d 130 (S.D.N.Y. 2010)

See also: http://scholarship.law.berkeley.edu/cgi/viewcontent.cgi?article=2112&context=btlj