Provigil Generic

[its2much]

I've seen some posts here that provigil is going generic next month. I'm assuming that mean April 2012. Right now it is extremely expensive - it's another drug I can't afford. Where can one locate information as to the date that it will be generic and the new cost?

[jessiesmom]

There is no generic form of Provigil sold in the U.S. at this time. Provigil is protected in the U.S. by a patent that does not expire until 2014 and that covers the pharmaceutical composition of the form of modafinil contained in Provigil.

The FDA granted preliminary approval to Barr Pharmaceuticals Inc. in 1/2004 and to Ranbaxy Laboratories Limited 2/2004 to market generic forms of modafinil. That means that the FDA deemed the generic versions to be safe, effective and bioequivalent to Provigil. The drug companies will not, however, have a product on the shelves any time soon because Cephalon, Inc., the U.S. maker of Provigil alleges the companies are infringing on its patent on the drug. Lengthy legal battles will most likely continue before any generic prescription of Provigil is made available in the U.S.



Cephalon made an agreement with four major generics manufacturers Teva, Barr Pharmceuticals, Ranbaxy Laboratories, and Watson Pharmaceuticals between 2005 and 2006 to delay sales of generic modafinil in the US until April 6, 2012 by these companies in exchange for upfront and royalty payments. Litigation arising from these agreements is still pending including an FTC suit filed in April 2008. Apotex received regulatory approval in Canada despite a suit from Cephalon's marketing partner in Canada, Shire Pharmaceuticals. Cephalon's 2011 attempt to merge with Teva was approved by the FTC under a number of conditions, including granting generic US rights to another company; ultimately, Par Pharmaceutical acquired the US modafinil rights.


The litigation is extremely complex but I hope this has given you a little of what you hoped to find.

[Tapdancer]

So which is it? April, 2012 or 2014? I have always read that it would be off patent in April 2012. I know it can take up to a year or so for the price to actually come down after a drug goes off patent. Are we looking for Par Pharmaceuticals to sell this?

[poohb3ar]

i knew about the april 2012 and was banking on it to go backon provigil and be almost normal again!!!

i refuse to pay the ridiculous price they're asking, even after ins., even if i could afford to hand them 1/2 by disability check every mo.!!
it's just plain greedy!!! they know they can charge whatever they want and lots of people or ins. will pay it.

if they're in legal battle after making a deal that's even worse! who knows when all the red tape will be sorted out.

oh well, i'm thankful for the 2 mos. i was finally able to take it (took 2 yrs of appeals to get it!)

take care and may God bless ya!

[schnauzerbrows]

This came across my SkyGrid this morning:

JERUSALEM--(BUSINESS WIRE)--

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA - News) announces the launch of the authorized generic of Provigil® (modafinil). Provigil® is marketed by Cephalon, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd. This product will continue to be manufactured under the brand product's new drug application at the same facility where it is currently produced. Shipping of the product has commenced.
The brand product had annual sales of approximately $1.1 billion in the United States, based on IMS sales data.

------------

Shipping of the product has commenced? w00t!

------------

schnauzerbrows
Obey the schnauzer!

[Tapdancer]

schnauzer, you made my day! Thanks so much for the report.

its crazy, when i first started taken provigal it was like 1100 bucks a month now its like 2100 thank God its free for curtisey of Uncle Sam and Tri Care