Shares of Teva Pharmaceutical Industries Ltd.  (TEVA)  declined 3.8% to $18.52 on Tuesday as Novartis AG's (NVS) Sandoz unit announced it had gained approval from the U.S. Food and Administration for a generic version of multiple sclerosis drug Copaxone.

Sandoz announced the launch of Glatopa (glatiramer acetate injection) 40 mg/mL, which Sandoz developed with its collaboration partner Momenta Pharmaceuticals Inc. (MNTA) .

Novartis' American depository receipts traded at $83.60, down 0.5%, while shares of Momenta were down 1.8% to $16.00. 

The approval likely came earlier than expected, according to Leerink Partners LLC analyst Ami Fadia in a note.

"Previously, Momenta had been guiding to a launch in 1H18 and Teva's assumptions were for a launch as early as April, and we had modeled an early 2Q18 launch," Fadia wrote.  

"Our preliminary estimate for the impact of a ~6 week earlier launch of a 2nd generic Copaxone 40mg on Teva is ~$115M in 2018 sales and $0.09 in EPS," Fadia added.

In an email to TheStreet, a Teva representative said the company has anticipated and planned for a second generic Copaxone to enter the market this year, adding: "We remain committed to providing Teva's COPAXONE (glatiramer acetate injection) 40 mg to patients and continuing to support our patients with the wide range of resources available from Shared Solutions."

This is the second generic Copaxone 40 mg/mL greenlighted by the FDA, following the approval in October of Mylan NV's (MYL) generic versions of both Copaxone 40 mg/mL and 20 mg/mL.

The FDA in 2015 approved Sandoz and Momenta's Glatopa as a generic version of Copaxone 20 mg.

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