NOTICE Notice: This is an old thread. The last post was 722 days ago. If your post is not directly related to this discussion please consider making a new thread.
Results 1 to 18 of 18

Thread: Provigil Generic Scheduled for April 2012. [modafinil]

  1. Default Provigil Generic Scheduled for April 2012. [modafinil]

    Cephalon made an agreement with four major generics manufacturers Teva, Barr Pharmaceuticals, Ranbaxy Laboratories, and Watson Pharmaceuticals between 2005 and 2006 to delay sales of generic modafinil in the US until April 2012 by these companies in exchange for upfront and royalty payments.
    http://en.wikipedia.org/wiki/Modafinil#Patent_protection_and_antitrust_litigati on

    I haven't been able to find recent news - is this still going to happen? I haven't even seen talk about it on the forums, though discussion of sources for ******** modafinil continues.

    I'm excited, I think?
    Like fish_bulb liked this post


  2. Good News!

    3/30/2012 10:45:18 AM

    JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) 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.

    (Teva acquired Cephalon in 2011)

    edit: Replaced the image with text. It was the first article I saw - I was excited!
    Last edited by ssj.long; 04-01-2012 at 10:01 PM.
    Helpful fish_bulb Rated helpful
    Like Gladheart liked this post

  3. #3
    That is funny, my doctor wouldnt prescribe provigil for night shift sleep disorder but now he is ok with prescribing nuvigil but there is no generic since that is relatively new. Arent they very similar? Glad there is a generic soon to be available, provigil, and nuvigil are outrageously priced.
    Be kind, everyone is fighting their own battles

  4. Default Provigil vs Nuvigil

    Provigil and Nuvigil are actually the same drug- the difference is that provigil is a racemic mixture of R and S forms of modafinil, whereas nuvigil is pure R-modafinil. In terms of effects, there's very little difference- there's some evidence that the R form is eliminated more slowly, but both forms are pharmacologically active, so it's not a big deal (vs Ritalin and Focalin, where only the D form is active, allowing smaller dosing with fewer side-effects).

    In the short term, I can understand where your doc is coming from- with the release of generic provigil coming up, (an authorized generic supposedly started shipping last week, though I've yet to see it) Cephalon, and now Teva (which purchased Cephalon last october) stand to lose a lot of money. To give you an idea, yearly sales of provigil are over 1 billion US$, even with a one month supply costing in excess of a thousand dollars. In an effort to prevent that, Cephalon released Nuvigil (the patent for which is good for the next decade) and drastically increased the cost of provigil- it's actually about 30% more expensive than the newer version, which is completely artificial.

    Docs prescribe modafinil for all sorts of reasons, but the only FDA approved uses are Shift work sleep disorder, narcolepsy, apnea, and day-time sleepiness- those are thus the only ones that insurance will usually pay for- and because of the price difference, many only cover nuvigil.

    So short term, your doc is probably thinking in your best interests- with or without insurance, nuvigil is cheaper. Long term though, there is no little benefit to nuvigil, and the provigil will likely plummet in price very soon (not much now, as it's an authorized generic- another way of saying that it's a brand name pill without the label- but regular generics should be available in september) Once the price of provigil falls enough, I would actually insist on it over nuvigil- the difference in effect isn't worth the cost. If the doc will still only prescribe nuvigil, find out what his reasoning is- and if it isn't logical, find another doc.

    Hope that helps.
    Helpful tzabcan, Gladheart Rated helpful
    Like fish_bulb liked this post

  5. Default Provigil Generic - More Funny Business

    I too was all excited that Provigil was going to go generic in April 2012. Then I found out that Teva, the first to market the generic on March 29, had received a six-month exclusivity ruling from the FDA. That means there will be no generic competitors with Teva for six more months.

    Here's where the fun begins. Last year Teva, the generic producer, bought Cephalon, the proprietary patent holder for Provigil and Nuvigil. So when Teva brought out its generic version, it was only competing with itself. They can keep the price of generic Modafinil as high as brand-name Provigil, because US consumers have nowhere else to go.

    Mylan Pharma, another generic manufacturer, has filed suit in an attempt to get this overturned. They claim various technical violations, and also that the FDA ruling effectively nullifies Cephalon's previous agreement in the antitrust settlement to allow Mylan to market Modafinil starting in April.

    What is even more hilarious is that when Provigil's patent expired 8 or 9 years ago, Cephalon bought off four generic producers to get them to refrain from competing with Cephalon. That is what brought on the initial antitrust suit and the consent agreement allowing Provigil to go generic in 2012. And who were those four generic companies? One was Teva, and another one was Mylan.

    So Cephalon paid Teva $200MM not to compete with Cephalon. Then Teva bought Cephalon (and presumably got its $200MM back). Now that Teva owns the company it was going to compete with, it has come out with the generic version of its own product, so it can hold off all other competitors for another six months.

    But the story gets better. As part of its acquisition of Cephalon, Teva agreed to license Par Pharma to market generic Modafinil. So Par will be able to compete with Teva's proprietary Provigil, after all. And Mylan, which sounded so righteous in challenging Teva's six-month exclusivity ruling, is actually seeking the same exclusivity for itself. If Mylan wins, there won't be any more competition than there is now.

    It's a wonderful life -- if you own a pharma company!


    Quote Originally Posted by ssj.long View Post
    Good News!

    3/30/2012 10:45:18 AM

    JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) 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.

    (Teva acquired Cephalon in 2011)
    Last edited by Malbone; 04-06-2012 at 12:04 PM. Reason: correction and additional facts
    Like MaggieA liked this post

  6. #6
    Join Date
    Nov 2011
    Location
    South Bay
    Posts
    605
    Gladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to behold

    I had very good insurance Aetna with my old company that covered Provigil and Nuvigil. I have switched companies and now have BlueCross BlueShield. I am worried that BC BS with not cover my Nuvigil script. I take Nuvigil to help me with my lack of energy as I detox from opiates using Suboxone. I know most insurance companies do not consider this use of the drug as a critical need. I have my fingers crossed that BC BS will cover Nuvigil. I would never pay $500 for 30 250mg pills! The retail price for this medication is outrageous! We need generic Provigil to be approved for the masses!

    It should be available to most folks insurance or not! Big Pharma Sucks!
    Live Free or Die

  7. I found a recent news release on the Par Pharmaceutical website regarding the availability of generic Provigil:

    WOODCLIFF LAKE, N.J., April 6, 2012 /PRNewswire/ -- Par Pharmaceutical Companies, Inc. (NYSE:PRX) today announced that it began shipping all strengths of modafinil tablets, a generic version of Teva's Provigil® brand. Par's initial shipments will comprise generically-labeled presentations of the Provigil® product. Par acquired the U.S. marketing rights to modafinil from Teva in connection with Teva's acquisition of Cephalon in 2011. According to IMS Health data, annual sales in the U.S. for Provigil are approximately $1.1 billion.
    However, at this point I see little reason to get too excited. I checked the cost of a 90 day prescription at the legitimate mail-order pharmacy Express scripts, and their current pricing is as follows:

    Brand Provigil 200mg Tablet, 90-day supply, $2,291.28
    Generic Modafinil 200mg Tablet, 90-day supply, $2,158.41

    Z



  8. Ten characters of mad.

  9. Thumbs down Not Overly Enthusiastic about Generic Provigil

    I have medicare, and each year since there has been a "Part D program," I go into the "donut hole" in March or early April due primarily to the cost of Provigil. I wasn't sure we would ever see a generic...I'm not sure we will now, exactly.

    My pharmacy was overjoyed to tell me that the generic had finally arrived. We put through my monthly prescription for 60 x 200 mg. and no one was prepared for what they saw next.....my co-payment went from $925.00 to over $1,400. for a one month's supply. The so-called generic (although if you look at the actual tablets - they are imprinted Provigil) was $500. more than the brand.

    In NYS once a generic is available the prescription must be filled that way, unless the doctor stipulates Dispense As Written so now I need a new prescription to get the medication at the lesser amount, if I could ever afford it.

    I wish they would provide a VIABLE generic and not just lip service.....
    Helpful Gladheart Rated helpful

  10. Quote Originally Posted by cesiumfluoride View Post
    Provigil and Nuvigil are actually the same drug- the difference is that provigil is a racemic mixture of R and S forms of modafinil, whereas nuvigil is pure R-modafinil. In terms of effects, there's very little difference- there's some evidence that the R form is eliminated more slowly, but both forms are pharmacologically active, so it's not a big deal (vs Ritalin and Focalin, where only the D form is active, allowing smaller dosing with fewer side-effects).
    This always confuses me. Isn't it "Armodafinil"? Or is Armodafinil just the name of the R-modafinil

  11. Provigil is the Cephalon branded name for the generic drug modafinil. Nuvigil is the branded name for the drug containing the pure R enantiomer of modafinil. In theory, R and S enantiomers of a chiral drugs generally have different biological properties, with one possessing the desired medicinal effects to a much greater extent. For this reason, the single enantiomer Nuvigil should be more potent than the racemate (since the R enantiomer is the "active" form). In practice some drugs undergo racemization, making enantiomeric drugs no different in potency to a racemic mixture, often with vastly different marketing and pricing structures. Omeprazole and esomeprazole are a good example of this sort of pharma price gouging.
    Like Gladheart liked this post

  12. #12
    Join Date
    Nov 2011
    Location
    South Bay
    Posts
    605
    Gladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to behold

    I feel it is all about marketing and keeping the retail price high for Cephalon on Nuvigil. I actually prefer Provigil over Nuvigil, but my doctor wants to write Nuvigil scripts. With the retail price for these drugs being so high I think it is just wrong that people without insurance that could really benefit from these medications don't have the cash to pay over $500 for 30 Nuvigil pills. I have been told that even though Provigil went generic the retail prices are about the same as Nuvigil. I know big pharma says they need to make back all their money spent on R&D.


    Just my .02 on these helpful medications.

    I apologize for posting almost the same information I posted back in April.
    Last edited by Gladheart; 07-15-2012 at 09:10 AM.
    Live Free or Die

  13. WhaT are the majority of people getting Provigil for? I have had a lot of dr unfamiliar with it... And it is too bad how costly it is.. there used to be an anti aging site that had it fairly cheaply.

  14. I've been reading a lot of recent papers on "next generation" modafinil development. Cephalon has made a ton of money from this class of compounds and they are definitely developing new agents with the same mechanism. I'll be very curious to see what follows from all this work.

  15. #15
    Me to I have used Modafinil and while there is no comparison to amphetamines IMO, it did work some what, it would be nice to see next gen to boost the focus and mood factor of the drug.

  16. #16
    Provigil is a hot topic now in the world... people consider it to be a "secret of success", giving energy and wish to move forward..quite funny that these pills have become like some miracle pills

  17. Not sure how many here will be able to follow the pharmacology, but here are links to the latest publications by the R&D teams at Cephalon in their quest for next-gen modafinil analogs.

    ScienceDirect.com - Bioorganic & Medicinal Chemistry Letters - Wake-promoting agents: Search for next generation modafinil: Part I

    ScienceDirect.com - Bioorganic & Medicinal Chemistry Letters - Wake-promoting agents: Search for next generation modafinil: Part II

    ScienceDirect.com - Bioorganic & Medicinal Chemistry Letters - Wake promoting agents: Search for next generation modafinil, lessons learned: Part III

    ScienceDirect.com - European Journal of Medicinal Chemistry - Wake-promoting agents: Search for next generation modafinil: Part IV

    Particularly interesting is the wake-promoting activity of compound 3 from paper III. Makes me wonder if the equivalent metabolite from modafinil, diphenylmethanol, is also responsible for activity. These structures are certainly not typical stimulant-type structures.
    Helpful DianeNYS Rated helpful
    Like Gladheart liked this post

  18. #18
    Join Date
    Nov 2011
    Location
    South Bay
    Posts
    605
    Gladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to beholdGladheart is a splendid one to behold

    I find Nuvigil and Provigil helpful. It sounds like they are working on a new and improved version of the drug for the future. I think they can do a lot with this medication to make it a "superpill" IMO. I only use Nuvigil may 2 or 3 days a week at most. CVS sure likes to bill my insurance company the outrageous rates for the medication. I have it on autofill and every 30 days I get an automated call from CVS your prescription is ready for pickup. Sometimes I skip a refill because I feel bad hitting my health insurance company for almost $500 for a medication I only need every other day at best.


    It is all about profit for these pharmacies and big Pharma! That is no secrete. My company has less than 5,000 employees, so I am sure it does not help the health plan premiums stockpiling this wicked expensive medication.

    I thought generic Provigil was coming out and would be priced reasonably. I have not seen the discount in the retail price. I personally prefer Provigil over Nuvigil. My doctor only likes to wrtie the new stuff. It really is just a big game that pushes up the cost of healthcare for everybody!

    *Again I apologize for posting similar information in several posts above. I am going to shut up on the topic as you know my feelings on the price of this medication*
    Last edited by Gladheart; 07-31-2012 at 06:45 AM.
    Live Free or Die


Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •  
Protected by Copyscape CopySentry. Do not copy.