Now cheaper Modafinil pills on the way thanks to Mylan Pharmaceuticals Inc.

[RockyBeach]

I am new to the ins and outs of the litigation and to the FDA process of moving drugs to generic status. Can someone catch me up / summarize where things stand on modafinil?

It sounds like Teva/Celaphon still have a corner on the market as they are now acting as suppliers to other manufacturers, such as Par. Do we know what Par's costs are?

Then it seems that with the above announcement, Mylan will begin shipping it August 10th, but will they produce it themselves or will they also purchase from Teva/Celaphon?

Why isn't it possible to see the entire agreement? Shouldn't this be available to the public if the FDA is involved in signing off on it?

Finally, how do Barr, Ranbaxy Labs and Watson Pharmaceuticals fit in. They had also made an agreement with Cephalon to delay selling generic modafinil until April, 2012. Why can't they now begin production?

[steel]

Modafinil helps me with my shift work disorder, a friend actually gave me a dozen, and it was godsent.Problem is at the moment I cannot afford to go to a doctor and am not sure exactly how and what pharmacy to trust to place an order, I am so new at this any help would be greatly appreciated.

[RockyBeach]

From the FDA, these companies have applied to produce modafinil, but none yet approved.



Drug Name and
FDA Application
Number Label
Info

Dosage Form/Route
Strength
Marketing Status
Company
MODAFINIL
(ANDA # 076594) Not Available TABLET; ORAL Multiple Strengths None (Tentative Approval) MYLAN PHARMA
MODAFINIL
(NDA # 076595) Not Available TABLET; ORAL Multiple Strengths None (Tentative Approval) RANBAXY LABS LTD
MODAFINIL
(NDA # 076596) Not Available TABLET; ORAL Multiple Strengths None (Tentative Approval) TEVA PHARMS
MODAFINIL
(NDA # 076597) Not Available Tablet; Oral Multiple Strengths None (Tentative Approval) BARR
MODAFINIL
(NDA # 076715) Not Available TABLET; ORAL Multiple Strengths None (Tentative Approval) CARLSBAD
MODAFINIL
(ANDA # 076935) Not Available TABLET; ORAL Multiple Strengths None (Tentative Approval) SANDOZ
MODAFINIL
(NDA # 077667) Not Available TABLET; ORAL Multiple Strengths None (Tentative Approval) APOTEX
MODAFINIL
(ANDA # 077892) Not Available TABLET; ORAL Multiple Strengths None (Tentative Approval) CARACO
MODAFINIL
(NDA # 078963) Not Available TABLET; ORAL Multiple Strengths None (Tentative Approval) ORCHID HEALTHCARE

[Lershac]

Man I can't wait till all those guys get in the game. The generic for my wife's prescription is still over $1300 a month. She just is a zombie without the provigil and pretty normal with it. In the works getting insurance, but I don't know what we will do for the next year until the exclusionary period for pre-existing conditions expires.

[RockyBeach]

Well, now I am more confused than ever. The following is the latest info from the FDA. So if Cephalon has patent that does not expire until 2024, how is it that these generics can be produced?
___________________________________
According to FDA's Electronic Orange Book, Provigil has mulitple patents with the latest patent expiring on May 29, 2024.

The Electronic Orange Book is a resource that you may review the patent terms for FDA approved drug products.

The method to do a search is as follows:

Go to: the FDA site, Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Search by using: Search by Proprietary Name
Enter the drug name
Select an application number
Select "view" under Patent and Exclusivity Info for this product

You may also find information regarding patents of the FDA site in the Industry section How can I better understand Patents and Exclusivity?

Further, the US Patent Trademark Office (USPTO) is the regulatory authority in determinations of patent issuance. The FDA does not make the determination of whether a drug product or sponsor qualifies for a patent.

[limbus]

Have anyone tried to talk to their doctor about the generic modafinil and see the price differential? Have they start releasing the prices yet?

Provigil prices are disgustingly high ($1.2 BILLION last year), especially since Cephalon steadily hiked the prices to drive people to Nuvigil and rake in as much money as possible before the patent expiration (on Provigil).

I talked to someone at a Rite Aid pharmacy about generic Provigil. They had it listed in the computer, but it was not available yet. The price difference between brand/generic was minimal. I don't remember the exact cost difference although I want to say around $50, so it's still TOO EXPENSIVE.

The pharmacy said that the generic prices are roughly equivalent to the brand for quite awhile. Once multiple manufacturers can make generics then that cost savings is passed on to the consumer, but that's going to take time.

Calling the pharmacy is the best way to find out about prices, but even that's hard at times because they need insurance info to give YOU your specific cost based on their contract with the insurance company.

My family member had to switch to Nuvigil or go without. Unfortunately, Nuvigil/Provigil are the only "safe" stimulants the doc will prescribe because of a history of heart troubles.

[lettsfinds]

I have been able to get the generic through my insurance at 90 days for about $30.00 TOTAL. It was $100 per month! The difference is wonderful.

[loveoften]

Can someone help me understand how Modafinil compares to Adderall XR? These are all new to me and as I've been on Adderall for so many years, I wonder is changing between Adderall and a different ADHD drug might keep the Adderall dose more effective? Thanks!

[Dr-Feel-Good]

Thanks for the update!

[gotpitbull]

I called CVS- oh... only 1,340! that's generic modafinil. It's still a freakin joke! What sux, is I'm in the coverage gap- thanks to Nuvigil- I pay 100% for everything, and still have to pay for drug insurance!

[the Punisher]

yes, here in my place is the price going down for 5 euro. hope that is not the end. but the quality wasn t that what vigil was. funny i thought they bought for a lot of millions the hole
stuff with anything on it....

[NastyNate]

To keep you guys updated. Mylan is now selling Generic Provigil Doses.

Mylan receives OK to sell generic Provigil doses - Businessweek

[renhall]

To keep you guys updated. Mylan is now selling Generic Provigil Doses.

Hopefully they will reduce their prices soon

[howardq99]

new to the forum here, I was just given a script by my doc for Provigil. Wow I can't believe the cost on that stuff at my local costco. No insurance so I'll have to look online for a less expensive alternative. Looks like I'll be spending the next several hours here doing some more research. Thanks for all the info!