MS Speaks

At long last the generic version of Copaxone has been approved though it's not known yet when it will be available or at what cost. Meanwhile, Teva Neuroscience has very cleverly come out with the 3-times-a-week Copaxone and encouraged people to switch to it. It will NOT be available in a generic form for years because its patent protection will last a while.

So if you want the generic Copaxone, you'll still be doing daily shots.

From the New York Times, April 16, 2015:

Generic Version of Copaxone, Multiple Sclerosis Drug, Is Approved

By ANDREW POLLACK

The Food and Drug Administration on Thursday approved the first generic substitute for Copaxone, a widely used drug for multiple sclerosis and the biggest selling product for Teva Pharmaceutical.

The approval of the generic, which was developed by the team of Sandoz and Momenta Pharmaceuticals — could bring some price competition to the market for multiple sclerosis drugs. Prices for those drugs have tripled in the last several years, to over $60,000 a year, even as more products have come to market, seemingly defying the laws of economics.

It was not immediately clear when the generic version would go on sale and how much it would cost. Teva may still have a patent that extends until September.

Teva is the largest manufacturer of generic drugs in the world and has often challenged the tactics used by brand-name drug companies to stave off generic competition.

But with Copaxone, which is a brand-name product, Teva has resorted to many of those same tactics.

It began selling a more concentrated formulation of Copaxone that requires an injection only three times a week instead of once a day, and it priced the new version lower than the old one to encourage people to switch.

About two-thirds of patients using Copaxone have already switched to the new version, which has patent protection that lasts for many more years. It might now be hard for insurers to get patients to switch to the lower-priced generic, which is a copy of the original Copaxone and requires injections every day.

Teva has also filed petition after petition with the F.D.A. arguing that Copaxone, known generically as glatiramer acetate, has such a complex composition that it is impossible to prove a generic is an exact copy and that subtle differences might harm patients.

In announcing the approval on Thursday, the F.D.A. sought to assuage any such concerns.

“Health care professionals and patients can be assured that F.D.A.-approved generic drugs have met the same rigorous standards of quality as the brand-name drug,” Dr. Janet Wood, the director of the agency’s drug division, said in a statement. “Before approving this generic product, given its complexity, we reviewed additional information to make sure that the generic product is as safe and effective as the brand-name product.”

A little more information here. The court ruling might speed up the availability of Glatopa by a few months but not necessarily. From the New York Times Business Day, June 18, 2015:

Ruling May Clear Way for Generic Version of Multiple Sclerosis Drug

By ANDREW POLLACK

A federal appeals court on Thursday again invalidated a patent protecting Teva Pharmaceutical’s big-selling multiple sclerosis drug, Copaxone, which could clear the way for the introduction of a generic version.

The first generic, developed by Sandoz and Momenta Pharmaceuticals, was approved by the Food and Drug Administration in April. But the companies have not started selling it, perhaps because they wanted to wait for the ruling on the patent.

A spokeswoman for Novartis, which owns Sandoz, welcomed the decision, but would not say when the generic drug would go on sale.

Teva suggested it would not give up trying to block the generic, saying it was “committed to pursuing all legal pathways, including seeking further appellate review.”

The patent in question will expire on Sept. 1 anyway.

Copaxone is one of the leading drugs used to treat multiple sclerosis. The price of the drug has jumped from about $9,000 a year when it was introduced in 1996 to around $60,000 now.

A generic could provide some price relief. Sandoz and Momenta have not said how much they will charge for their generic version, which they have named Glatopa.

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. About $3.1 billion of those sales were in the United States.

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 many patients to a new formulation that requires 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.