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I suppose I'm the guilty one who's been throwing that date around wim.
Here's the "speculative" answer.
Teva was granted FDA approval on the 40mg (1) yr. ago on 11-19-13, I believe, as well as the 30mg and tentative on the 15mg if I remember correctly. Since they were first to file on the 40mg they were given 180 exclusivity to market, just like IPCI was given on the 15mg.
By all rights that exclusivity should have expired at the same time IPCI's expired in May IF they had launched which I don't believe occurred.
So it would appear they launched on May 28th with the 15mg and perhaps their 30 mg as they're all listed in this link on the same day.
I would think IPCI is keeping their eye out for approval after the 28th, imo.
http://www.empr.com/teva-launches-generic-focalin-xr/article/348893/
SAR flip again, Doog
Trading above the 50dma with the breakout volume.
And we're off. Picked up some more to help
Haven't heard that one in awhile, Tony. You think we'll have reason to celebrate?
Nice to see 10 mm's on the bid ABOVE the last close. Don't see that very often do we?
Looks like Rexista, etal, will still be a better choice.
"These drugs, along with Hysingla, can still be abused when swallowed intact — the most common method for abusing painkillers."
The best possible news we could hope for is a partnership with Pfizer in regards to Regabatin (pregabalin), Z, good choice.
They are locked in with (4) more yrs until their (2) remaining patents expire with Lyrica. The generic's got together to challenge their rights and lost out in the appeals court earlier this yr. Our once a day formula would be an attractice come-on to replace (3) of their tablets. At $4 a pop (and $360/month/user) that'll be a significant jolt to their earnings in a few yrs. Makes all the sense in the world to front-load IPCI through their phase 3 trials and keep some of that market that'll be lost to generics starting in 2018.
Nice news Doog. I knew Teva's launch had to be recent since I've been keeping an eye out for their launch's. Nice that IPCI is keeping a lookout also.
It appears it was on the 11th of this month. Note the 40mg has been listed as well, like I thought, so, hopefully, we'll get an approval on it soon.
http://www.empr.com/teva-launches-new-generic-focalin-xr-strength/article/382530/
"This move is like a star free agent from a championship sports team suddenly jumping ship to an upstart team he feels he can win another championship with!"
Umm, er, Dr Oddidi just call me by my nickname "Le Bron", lol.
Oh and uh and make my Lambo red!
Doog, his credentials oozes with "get er done" style. He'll be the running back of the organization. Give him the ball and watch. There's no doubt, after reading that article, (at least for me), that he doesn't feel empowered to get to the end result which, in our present case,is our upcoming parnership/licensing deals coming up.
One thing we all might keep in mind is that the longer we wait for Rexista news the more confident we should become that the news we're waiting for (phase 1 trials with PODRA's) may be done by the time we hear about it, instead of getting started. If I remember correctly the phase 1 trials for PODDD's were never pr'ed and we weren't aware of them until after they were done.
So, I think 12 weeks with 12-14 trial applicants is about right to get PODRA's phase 1 done. In any event, perfect timing for Domenic to do what he does best, deciphering value, and bringing home the bacon with lucrative phase 3 deals on both our NDA's and, as you mentioned, any of our ANDA's the company chooses to partner with.
Yeah I think what sealed the deal with the Oddidi's was his comment he was going to make Teva his b*itch
Great selection by the company Doog. Great qualifications and self-motivated to be totally engulfed in the business and not just typical CFO duties.
Everyone notice his last interview detailing his involvement at Teva with a picture. Very seasoned individual.
http://advantagemagazine.ca/2014/teva-canada/
Well, you did alright, better than those that bought in the 2.80's before a seller showed up yesterday.
Won't be long when we'll leave these levels for good anyway.
Sounds good Z. Put that "probe" of money on this "comet" and see where it will take us.
Hey Muddy, we've touched on this with speculation as to what is going on with Teva since their exclusivity period should have expired at the end of May IF they had launched upon approval. The short answer is they(Teva) appear to be in the drivers seat as per the regulations which have been challenged in court and then appealed by many companies on different drugs.
There are several issues here, as I see it. The reason IPCI/Par had reached settlements with the other companies is because they can defend their Focalin cocktail as being different utilizing their proprietary formulation technology. This was important because the patent for Focalin doesn't expire for another year yet and they figured they would be coming to market prior so they didn't want any problems, upon approval.
I don't think Teva wants to risk going to market with the lower strengths because they may not be in a position of strength in a court battle with the technology basically unchanged and even if they did prevail it would undoubtedly be appealed and possibly loose anyway. I think that's why they pulled them off the market before. Also this deceision would make sense from a business standpoint if the "active ingrediant", for ADHD, that is controlled by the DEA, is indeed in short supply. Teva can therefore kill several birds with one stone: stay out of litigation, make more money at the higher dosages and lock-in the exclusivity period until they're ready to take advantage of it.
While we've touched on IPCI to take litigation action against this "gaming" of the rules, with only a yr left on the patent I would think that would be a waste of money for IPCI to pursue. It took the company a yr. to settle with Novartis, etal before.
It will be interesting to see if we pick up the 40mg for sales after the 28th of this month without a hitch which we should, imo.
So, attached is the rules such as they are. There doesn't appear to be a "statute of limitations" just litigation to fight it if the company so desires. I highlighted the answer in bold lettering:
The statute provides an incentive of 180 days of market exclusivity to the "first" generic applicant who challenges a listed patent by filing a paragraph IV certification and running the risk of having to defend a patent infringement suit. The statute provides that the first applicant to file a substantially complete ANDA containing a paragraph IV certification to a listed patent will be eligible for a 180-day period of exclusivity beginning either from the date it begins commercial marketing of the generic drug product, or from the date of a court decision finding the patent invalid, unenforceable or not infringed, whichever is first. These two events - first commercial marketing and a court decision favorable to the generic - are often called "triggering" events, because under the statute they can trigger the beginning of the 180-day exclusivity period.
In some circumstances, an applicant who obtains 180-day exclusivity may be the sole marketer of a generic competitor to the innovator product for 180 days. But 180-day exclusivity can begin to run - with a court decision - even before an applicant has received approval for its ANDA. In that case, some, or all, of the 180-day period could expire without the ANDA applicant marketing its generic drug. Conversely, if there is no court decision and the first applicant does not begin commercial marketing of the generic drug, there may be prolonged or indefinite delays in the beginning of the first applicant's 180-day exclusivity period. Approval of an ANDA has no effect on exclusivity, except if the sponsor begins to market the approved generic drug. Until an eligible ANDA applicant's 180-day exclusivity period has expired, FDA cannot approve subsequently submitted ANDAs for the same drug, even if the later ANDAs are otherwise ready for approval and the sponsors are willing to immediately begin marketing. Therefore, an ANDA applicant who is eligible for exclusivity is often in the position to delay all generic competition for the innovator product.
Only an application containing a paragraph IV certification may be eligible for exclusivity. If an applicant changes from a paragraph IV certification to a paragraph III certification, for example upon losing its patent infringement litigation, the ANDA will no longer be eligible for exclusivity.
Back to Top
Court Decisions and FDA Actions
This 180-day exclusivity provision has been the subject of considerable litigation and administrative review in recent years, as the courts, industry, and FDA have sought to interpret it in a way that is consistent both with the statutory text and with the legislative goals underlying the Hatch-Waxman Amendments. A series of Federal court decisions beginning with the 1998 Mova1 case describe acceptable interpretations of the 180-day exclusivity provision, identify potential problems in implementing the statute, and establish certain principles to be used by the Agency in interpreting the statute.
In light of the court decisions finding certain FDA regulations inconsistent with the statute, the Agency proposed new regulations1 (Federal Register notice) in August 1999 to implement the 180-day exclusivity.
Since then many comments have been submitted and there have been additional court decisions further interpreting the 180-day exclusivity provision and complicating the regulatory landscape. The Agency has not yet published a final rule on 180-day exclusivity. As described in a June 1998 guidance for industry, until new regulations are in place, FDA is addressing on a case-by-case basis those 180-day exclusivity issues not addressed by the existing regulations.
One of the most fundamental changes to the 180-day exclusivity program that has resulted from the legal challenges to FDA's regulations is the determination by the courts of the meaning of the phrase "court decision." The courts have determined that the "court decision" that can begin the running of the 180-day exclusivity period may be the decision of the district court, if it finds that the patent at issue is invalid, unenforceable, or will not be infringed by the generic drug product. FDA had interpreted the "court decision" that could begin the running of 180-day exclusivity (and the approval of the ANDA) as the final decision of a court from which no appeal can be or has been taken - generally a decision of the Federal Circuit. FDA's interpretation had meant that an ANDA applicant could wait until the appeals court had finally resolved the patent infringement or validity question before beginning the marketing of the generic drug. FDA had taken this position so that the generic manufacturer would not have to run the risk of being subject to potential treble damages for marketing the drug, if the appeals court ruled in favor of the patent holder. The current interpretation means that if the 180-day exclusivity is triggered by a decision favorable to the ANDA applicant in the district court, the ANDA sponsor who wishes to market during that exclusivity period now may run the risk of treble damages if the district court decision is reversed on appeal to the Federal Circuit. As a practical matter, it means that many generic applicants may choose not to market the generic and thus the 180-day exclusivity period could run during the pendency of an appeal.
In one of the cases rejecting FDA's interpretation of the "court decision" language in the statute, the court determined that the applicant who relied in good faith on FDA's interpretation of the 180-day exclusivity provision should not be punished by losing its exclusivity. The court, therefore, refused to order FDA to begin the running of 180-day exclusivity upon the decision of the district court in the patent litigation at issue. FDA has taken a similar approach in implementing the courts' decisions: the new "court decision" definition will apply only for those drugs for which the first ANDA was submitted subsequent to March 30, 2000. In adopting this course, a primary concern for the Agency was to identify an approach that would minimize further disruption and provide regulated industry with reasonable guidance for making future business decisions.
To advise the public and industry of this position, FDA published a Guidance for Industry2 in March 2000. FDA intends to incorporate the courts' interpretation of the "court decision" trigger for 180-day exclusivity into the final rule implementing the changes in 180-day exclusivity.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069964.htm
I agree Doog. Just on the Rexista front this says a mouthful:
"We believe this confirms our thinking that IPCI has the best-in-class abuse resistant and tamper resistant formulation of oxycodone."
Thanks for posting the report and link, hog. Only a small portion with no link was posted on 10-27.
Not understanding their math however when, at the time of the article, (3) of our ANDA's hit the (4) yr mark last month even after starting the clock upon FDA acceptance for filing rather than the company filing date which would have been even more time. Clearly the first in, first out system is compromised if they still believe the average time for approval is "currently" 36 months. Also, if they don't understand the delay, they realistically can't come up with an approval timeline themselves so the 12-18 months was just thrown out there as a catch-all in their report,imo.
Personally, I think what's happening, if one looks at the monthly ANDA reports, it's apparent there's more emphasis put on proper current safety labelling, changes and additions with supplements and other data on approved drugs with the unreviewed ANDA's taking a back seat until the trained new reviewers get on board.
Regardless, we'll get there. I don't think we're going to have wait that long however.
Looking forward to a licensing deal for Pregabalin and phase 1 final completion news with Rexista shortly.
I suppose you missed the one from (3) weeks ago?
http://ih.advfn.com/p.php?pid=nmona&article=64055848
Phosphate rock price unchanged for the end of October @ $115/mt.
"The Company intends to present the following information arising from its Regabatin™ XR product development program at the upcoming American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition in San Diego from Nov 2-6, 2014."
http://www.aaps.org/annualmeeting/
Morning Doog, yeah it's not like they can't divert their sales to the lower strengths, for the humanitarian needs of children, KNOWING the higher strengths are already covered by the competition with plenty of supply and also trying to lock out IPCI as long as possible on the 40, imo.
Teva still claiming shortages for Focalin as of (3) days ago affecting 2.5, 5, 10 & 40mg.
Novartis still on record as well.
Dexmethylphenidate Hydrochloride (Focalin) Tablet
Status: Currently in Shortage
» Date first reported: 02/13/2014
» Therapeutic Categories: Pediatric; Psychiatry
Novartis (Revised 04/30/2014)
Company Contact Information:
888-669-6682
Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Focalin 10mg Tablet (NDC 0078-0382-05) Available Please check with your wholesaler for available inventory. Demand increase for the drug
Focalin 2.5 mg tablet (NDC 0078-0380-05) Available Please check with your wholesaler for available inventory Demand increase for the drug
Focalin 10mg tablet (NDC 0078-0382-05) Available Please check with your wholesaler for inventory Demand increase for the drug
Focalin 5mg tablet (NDC 0078-0381-05) Available Please check with your wholesaler for inventory Demand increase for the drug
Teva Pharmaceuticals (Reverified 10/27/2014)
Company Contact Information:
800-545-8800
Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
2.5 tablet; 100 count bottle (NDC 0093-5275-01) Available Shortage of an active ingredient
5 mg tablet; 100 count bottle (NDC 0093-5276-01) Available Shortage of an active ingredient
10 mg tablet; 100 count bottle (NDC 0093-5277-01) Available Shortage of an active ingredient
40 mg ER Capsule; 100 count bottle (NDC 0093-5562-01) Available Shortage of an active ingredient
-
http://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Dexmethylphenidate Hydrochloride (Focalin) Tablet&st=c&tab=tabs-1#
I think we were doing better when you were chasing tornado's in Kansas. We'll see if curbing lava flow will be as good
Yep, knocking on 3.50's door would be nice!
Ultra low volume but $3+
Nice reiteration by Mackie, Doog. Ole Andre keeps in close tabs with the company since he's been to their facility (3) times this yr.
Let's pray for another failed 3rd phase3 trial by Pfizer to capitalize big, lol.
Looking good for IPCI regardless as the market is big enough to accomodate them.
Nice close Doog. Shares were held tight all day. Let's hope for a follow-through tomorrow to solidify that bust through the 50dma.
Thanks for the info, hog, appreciate it!
That's good to know. What determines the switch/capture? The product?, purchasing agent?
Lots of competition in the Protonix market versus the other (2) ANDA's so I would be thrilled if they could corner 5% of it. More than that we should be estatic and it would say volumes of their product.
Nice Doog, was waiting for an analyst report and reiteration on the earnings release, thanks.
SAR flip today!, eom
Nice to hear Regabatin phase 1 trials being successful. We were so engulfed with Rexista it was almost an afterthought that we were due news on this front. Now let's finish phase 1 trials on Rexista and get both of these partnered for phase 3.
Yep, little did IPCI envision the market dynamics at play, at present, upon approval, when they submitted their Focalin ANDA yrs. ago.
The next (3) ANDA's however aren't dealing with treatment of ADHD, are all in the generic markets already with Teva in those spaces already as well, and aren't tracked by the DEA at all in any category. So we should hit the market running as we had originally envisioned for Focalin but without the snags we've thus encountered. Market share will determine our fate nothing else.
Some dated fun facts for us to be aware of upon approval:
*metformen (Glucophage XR) is now believed to be the most widely antidiabetic drug in the world. In the U.S. alone more than 48M perscriptions were filled in 2010.
*venlafaxine (Effexor XR) In 2007 venlafaxine was the 6th most commonly prescribed antidepressent in the U.S. retail market with 17.2M perscriptions.
*pantoprazole (Protonix) treats gastro-esophageal reflux disease (GERD). In the western world between 10-20% of the population affected.
Nothing exciting awaiting news from our next ANDA approval and Rexista update. Just relaying the facts for the wonder why people. We may need help getting through the 50dma @2.85 regardless of the market.
For anyone who may be interested. While I was researching the launch of Focalin 40mg by TEVA, the lack of the launch of lesser dosages by TEVA and the shortages of the drug going back 5+ yrs., it became apparent something wasn't right. It will be interesting if we launch the 40mg within a couple of weeks from the 28th of Nov. just as TEVA did when we lost our exclusivity at the end of May. The question will be, will Par get additional methylphenidate to make the tablets. Hopefully they won't have a problem and will launch as they have done before.
It would appear the drug is a Schedule 2 controlled substance listed in the Controlled Substance Act (CSA) listings. This falls under the stewardship and control of the Drug Enforcement Administration (DEA). Schedule 1 drugs aren't legal. Schedule 2 drugs are considered to have a "high potential for abuse" so they're monitored and quotas approved as they deem appropriate. The problem is the DEA is behind the curve, not in front, and seem to feel we have adequate supply to meet the need. Their position seems to be the drug companys' control the supply to the most lucrative markets at the expense of the cheaper generics. Thus the general public hasn't been getting the benefit which is acknowledged in my last post in 1 of the links. Teva had launched the lesser strengths yrs ago but pulled them. The DEA also feels the drug is oversubscribed and abused and therefore supply is adequate. As in 1 of the links I've provided, the FDA has been countering their claims but the DEA has the power it seems. The links are 2-3yrs old but it does show us how long this has been a problem. Granted this may not affect us when we have approval for the 40 mg but unless this political quagmire comes to some sort of victory for the consumer, Teva won't/can't relaunch their lower Focalin strengths keeping us out of those markets it would seem.
I hope we have greater flexability and less regulation to be concerned about when our opiods go to market as they're listed as well.
May be nothing to be concerned over but I personally like to be informed of what's going on especially when things don't add up and our free market system is being tampered with especially at the expense of the general public. The need is rising each yr. Hopefully they'll get ahead of the curve instead of behind. They did raise quotas 2 yrs ago but apparently still not enough.
Note: There're links inside the links for additional info.
http://www.nytimes.com/2012/01/01/health/policy/fda-is-finding-attention-drugs-in-short-supply.html?pagewanted=1&_r=3&
http://psychcentral.com/blog/archives/2012/01/02/dea-doesnt-care-about-adhd-medication-shortage/
http://www.raps.org/focus-online/news/news-article-view/article/1880/dea-to-increase-supply-of-adhd-opioid-ingredients-in-light-of-shortages.aspx
"the FDA has really stepped up to lighten up the heavy ANDA backlog they faced..."
Hey Z,
Perhaps this may be a feeble attempt to clarify our expectations just a tad. As you yourself noticed there's a slowdown in the monthly ANDA approval tally. I think the disconnect is the FDA is working the backlog however they think appropriate utilizing the Complete Response Letter (CRL) as their means of communication with the companies if they have questions. The response(s) is/are then resubmitted back to the FDA. First, just a little background (bare with me)
Our dilemma as we are all aware is the FDA staffing didn't keep pace with the workload. I believe I read they didn't hire anyone for 5yrs. From 2006-2009 the ANDA backlog was growing @ 200 new applications/yr. 2010 & 2011 it doubled to 400/yr now totaling 2700, at this point, needing review. The approval timeline went from 16.6 months in 2005 to 26.7 in 2009 alone before the big push getting this out of hand.
As we know, the Generic Drug User Fee Act (GDUFA) went into affect on 10-1-12, the start of the FDA fiscal yr., to address the problem by charging ANDA fees to hire more people. If an ANDA was already in the system prior to 10-1-12 then $17k/ANDA was required to stay in the system. That figure came about to generate $50M divided by the # of ANDA's in the system. All new ANDA application fees after 10-1-12 would increase to $51k.
As you might guess, there was a rush by some applicants to get their submission in before that date to save money upfront even though the review time was suppose to be a little quicker and loosing out on the early revenue upon approval.
The problem is when the GDUFA went into affect the FDA stated they would "review and act upon 90% of the backlog (applications pending on 10-1-12) by the end of FY 2017." So what happens to the applications submitted in Sept 2012 to avoid the increased fees? They're at the end of the backlog and may not get reviewed in 5yrs. as per their statement as that would be 100%. At the end of 2017, it is planned to review 80% of the applications in 12 months. (ummm... ok)
So the ANDA fees are projected to bring in 921 extra people over a (3) yr period. 234 were added in 2013, 461 were to be added this yr. and the balance (226) next yr. All we know is they're added to reduce the backlog but the paperwork has increased dramatically as well. Prior to 10-1-12, a simple phone call would solve some questions and the review could continue. The CRL's now utilized are chewing up a lot of time and ANDA approvals are suffering as a result. While IPCI's submissions may be flawless, the review process is slowed getting to them which is what I think we're seeing.
Some other functions this extra help will cover is lab inspections (both home and abroad), issuing application rejection notices, maintaining drug master files (DMF), etc. Several changes in drug labelling is part of the review process along with stability testing requirements that have been implemented recently that need reviewing.
The reason I'm bringing all this out is because OCT 2013 new ANDA application fees increased again from $51k to $63k to hire 50 scientists as reviewers. So as suspected, the 921 people previously announced, didn't have enough ANDA reviewers which is what we're all hoping for to speed things up. They were suppose to be on board and trained by now (6-8 months). Since that deceision, the new ANDA applications are projected @1500 for this yr versus 400 just (3) yrs. ago. 600 came in June alone.
So, in summary, what we want to hear as investors is there's a recent addition of scientists on board each grabbing an ANDA to review rather than doing other functions to reduce the backlog.
I've attached a few links giving additional useful info. Hope there are some that found this post useful. I did my best to keep it short, lol.
http://www.pharmacytimes.com/publications/issue/2014/July2014/Will-Lagging-Generic-Approval-Rates-Increase-FDA-Backlog
http://blogs.wsj.com/pharmalot/2014/07/29/is-fda-buried-under-a-backlog-of-generic-drug-applications/
http://www.drugstorenews.com/article/gdufa-tackles-backlog-drug-approval-applications-fda-hires-more-staff
Agreed Doog. Don't know how accurate those short #'s on Yahoo are but an additional 1.29M shares that need covering can't hurt either, lol.
I've been doing the same Z. I'll post a more extensive dd later but for now don't forget mopar's post (2) months ago
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=105662438
This is suppose to be a first in first out system. It shows they're chewing through the Oct, 2010 submissions. So I'd like to think it's in some clamy scientists hands already, lol.