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.