So far, the market looks ripe for copies of Teva's ($TEVA) multiple sclerosis hit, Copaxone. And Pfizer ($PFE) wants to get in on that.
The pharma giant has inked a pact with generics-maker Synthon, whose knockoff of the blockbuster is under FDA review. Pfizer will market the product in the U.S.--provided it wins regulatory approval.
"Pfizer's significant experience in successfully bringing meaningful medicines to market together with Synthon's scientific expertise in neurodegenerative diseases will enable us to leverage our core capabilities in support of improving patient health in the United States," said Diem Nguyen, Pfizer's North America president for established products, in a release.
Only one Copaxone copy has yet launched since a U.S. court struck down Teva's patent on the treatment, and that's Glatopa, a knockoff from Momenta Pharmaceuticals ($MNTA) and Novartis' ($NVS) Sandoz unit. That drug got off to a quick start this summer, racking up 18 prescriptions in its first week of launch--a number that had soared to 472 by the two-week mark.
That trajectory flattened out a bit in the weeks that followed, according to Evercore ISI analyst Umer Raffat. But with MS drug prices hovering at about $60,000 per year, there should still be room for Copaxone generics to make their mark.
To fill the void, Teva has been switching patients over to a new, long-acting formulation of the drug, an endeavor that's scored enough success to surprise analysts. But after a lengthy court battle over the original formulation's IP protection, the new version is now under attack, too--and Synthon is among the attackers.
As Pfizer said in a statement, Synthon filed an ANDA for the thrice-weekly iteration of Copaxone back in early 2014, and it thinks it was the first to do so--meaning it could be eligible for 180 days of shared marketing exclusivity. And under the new marketing deal, that exclusivity would belong to Pfizer.
But other competitors are waiting in the wings, too. Last August, both Mylan ($MYL)--which is still awaiting FDA approval for its 20mg copycat--and the Momenta/Sandoz team announced that the FDA had accepted their ANDAs for the longer-acting 40mg dose.
- read Pfizer's release
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