Bloomberg Anywhere Remote Login Bloomberg Terminal Demo Request


Connecting decision makers to a dynamic network of information, people and ideas, Bloomberg quickly and accurately delivers business and financial information, news and insight around the world.


Financial Products

Enterprise Products


Customer Support

  • Americas

    +1 212 318 2000

  • Europe, Middle East, & Africa

    +44 20 7330 7500

  • Asia Pacific

    +65 6212 1000


Industry Products

Media Services

Follow Us

Bloomberg Customers

Teva May Face Copaxone Copy From Novartis, Momenta Next Month

A copy of Teva Pharmaceutical Industries Ltd.’s top-selling multiple sclerosis medicine Copaxone may win U.S. approval as soon as next month, Bank of America Merrill Lynch analysts said.

A 30-month stay of approval on the copy, manufactured by Novartis AG and Momenta Pharmaceuticals Inc., expires on or around Jan. 16, New York-based analyst Gregg Gilbert said in a note today. Approval of the generic is possible “at least in theory” on that day, though the Food and Drug Administration will likely need more time to review it, Gilbert said.

Teva has said the drug’s molecular structure is so complex that clinical trials should be required to prove that any copied version has the same effect. The drug has about 40 percent of the MS market, Gilbert said. It accounted for 18 percent of Teva’s $13.9 billion in sales last year and contributes “disproportionately” to profit, Teva said.

“While key patents protect the drug into 2014, generic challengers in the U.S. hope to launch sooner,” Gilbert wrote.

Teva has sued to block the copy from Basel-based Novartis and Cambridge, Massachusetts-based Momenta. The partners are free to launch at-risk without warning Teva beforehand if the FDA approves their copy, Gilbert said.

The Petah Tikva, Israel-based drugmaker has asked the FDA for approval of a lower-volume version of Copaxone. A ruling on the new version of the drug may come after Jan. 1, Gilbert said.

Please upgrade your Browser

Your browser is out-of-date. Please download one of these excellent browsers:

Chrome, Firefox, Safari, Opera or Internet Explorer.