TEL AVIV, July 25 (Reuters) – Shares in Teva Pharamaceutical Industries (TEVA.TA) fell sharply on Sunday on fears of looming competition for its blockbuster multiple sclerosis drug Copaxone.

Shares in Teva, the world’s biggest generic drugmaker, were down 5.8 percent to 198.80 shekels at 0933 GMT, after its Nasdaq shares (TEVA.O) slid 8.6 percent to $49.38 on Friday.

U.S. health regulators approved on Friday the first generic version of widely used Sanofi-Aventis (SASY.PA) blood clot treatment Lovenox to the Sandoz generic drug unit of Switzerland’s Novartis AG (NOVN.VX), which is allied with smaller partner Momenta Inc (MNTA.O). [ID:nN23123382]

The approval of the complex medicine has spooked Teva investors, who fear the FDA now might be willing to approve a generic version of Copaxone, which like Lovenox is complicated to make.

“If Momenta succeeded in getting approval for one complex molecule it’s possible it will also get approval for Copaxone, and soon,” Bank Hapoalim analyst David Levinson said.

Momenta and Novartis are seeking U.S. approval of a generic Copaxone, and Momenta said on a conference call on Friday it was working with the FDA on its Copaxone application.

Harel Finance analyst Steven Tepper said he believed the path to approval of a generic version of Copaxone is long and complicated and called the comparison with Lovenox weak.

“The complexity of Copaxone is different from that of Lovenox and the process of approval is expected to be different,” Tepper said. “Like Lovenox, the process for approving a generic version of Copaxone is expected to be long and take about five years.”

Teva said on Friday any potential generic version of Copaxone would need to be evaluated with full-scale clinical trials, given Copaxone’s complexity.

Copaxone is patent protected until 2014, and Momenta and Sandoz will have to persuade the courts they are not violating the patent, Harel Finance’s Tepper said.

Teva is also seeking to sell a generic form of Lovenox and Bank Hapoalim’s Levinson said investors questioned why the company had not received approval yet.

Teva said it believed its generic Lovenox met FDA criteria and could be approved.

“There is no doubt we are at the beginning of the end for Copaxone,” Levinson said.

Even if Copaxone sales continue to grow in the coming year or two, Teva’s shares will be volatile because the drug represents about 20 percent of Teva’s sales, he said.

“We believe these sharp drops represent a long-term buying opportunity,” Levinson said, who rates Teva outperform. “We believe the share is trading at a low price earnings multiple relative to the industry.”

Harel Finance’s Tepper maintained a buy rating for Teva but lowered his price target by $2 to $64 a share. ($1 = 3.85 shekels) (Editing by Karen Foster)