Teva Ruling Clears Way for Generic Version of Multiple Sclerosis Drug
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The first generic version of a multiple sclerosis drug went on the market Thursday, hours after a federal appeals court again invalidated a patent for the brand-name drug, Copaxone, a major moneymaker for Teva Pharmaceutical.
The generic drug, which will be made by Sandoz and Momenta Pharmaceuticals and will be called Glatopa, was approved by the Food and Drug Administration in April but the companies held off starting sales, apparently waiting for the court to rule on the patent.
Patients and insurers hoping for big price relief from the introduction of the generic might have to wait somewhat longer, however. Novartis, which owns Sandoz, said the generic version would have a wholesale list price of more than $63,000 a year.
That is about 18 percent less than the list price of Copaxone, according to figures supplied by Novartis, but hardly cheap. Sandoz said it would offer financial support to eligible patients, something not usually made available for generics.
There could be more price relief behind the scenes, if Sandoz and Teva vie to win favorable placement from insurers by offering bigger discounts and rebates. Prices might also drop if other companies, like Mylan, win approval from the F.D.A. to sell generic versions of Copaxone.
Teva suggested it would not give up trying to block the generic medicine, saying it was “committed to pursuing all legal pathways, including seeking further appellate review.”
Teva’s American depositary receipts closed up 18 cents, at $60.33, on Thursday though the shares dropped a little after hours. Momenta’s shares rose nearly 7 percent in regular trading and more after hours.
The patent in question would have expired on Sept. 1 anyway, if it had not been invalidated.
Copaxone is one of the leading drugs used to treat multiple sclerosis. The price of the drug has climbed steadily from about $9,000 a year when it was introduced in 1996. The original version, which the generic will mimic, requires one injection a day and now has a list price of about $74,000. A newer version of Copaxone, which requires three injections a week, costs around $60,000.
Copaxone is a rare brand-name product for Teva, which is mostly known for generics. It is also Teva’s biggest product, with sales last year of $4.2 billion, accounting for 21 percent of the company’s revenue and nearly half its profit. The United States accounted for about $3.1 billion of those sales.
Teva has fought hard to delay generic competition, filing one petition after another with the F.D.A., arguing that Copaxone was too complex a substance for a generic company to copy accurately. It has also switched most patients to the new formulation that requires only three self-injections a week, rather than an injection every day. That may make it harder for the generic, which also requires a daily injection, to gain traction.
The appeals court, the Court of Appeals for the Federal Circuit, first rejected the patent claim last year. Teva appealed to the Supreme Court, which in January said the appellate court might have erred and should reconsider the case.
The appellate court on Thursday, in a 2-1 decision, again invalidated the patent, but using somewhat different reasoning.
The issue was whether the patent claim was definite enough. The claim used the term “molecular weight” without specifying which of three possible methods should be used to measure it.
Story Source: The above story is based on materials provided by NYTIMES
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