Friday, March 05, 2010

Does Ranbaxy intentionally forfeited 180-day exclusivity for monetary benefit?

Often strategic business moves are played within the closed walls of the Management Boardroom that can even take market analysts with surprise. Lately, Ranbaxy failed to launch its generic version of Flomax which was expected to go on sales in the US market on March 02 with 180-day market exclusivity. Ranbaxy in its statement reasoned regulatory delay in obtaining final approval for its failure to launch generic Flomax.

Flomax is marketed by Boehringer Ingelhiem in the US and its active ingredient, tamsulosin hydrochloride is protected by the US Patent No. 4,703,063 issued to Astellas Pharma Inc. Ranbaxy had “First-to-File” status for generic version of Flomax, with Impax Laboratories in paragraph IV race. Ranbaxy got sued by Boehringer and Astellas for patent infringement but in November 2007 announced out-of-the-court settlement that allowed Ranbaxy to launch its generic Flomax on March 02, 2010 i.e., eight weeks ahead of the expiration date of ‘063 patent. Similarly, Impax got sued for patent infringement and in October 2009 announced out-of-the-court settlement with Boehringer and Astellas interestingly having similar sort of arrangement (as that of Ranbaxy) that allowed Impax to launch its generic Flomax on March 02, 2010.

Now the question is when Astellas/Boehringer already entered into a settlement deal to allow FTF generic company Ranbaxy to launch its generic Flomax on March 02, 2010 knowing that the Ranbaxy also entitled to 180-day market exclusivity then how Astellas/Boehringer made similar sort of agreement with Impax to allow its generic Flomax launch on March 02, 2010? Does Ranbaxy which received tentative approval for its generic Flomax more than two-and-half years back (June 2007) seriously failed to obtain regulatory clearance despite settling patent dispute back in November 2007 with clear idea of launch date? Or does Ranbaxy made some strategic deal to allow Impax to launch its generic version on March 02, 2010? If yes, then with whom --- Astellas/Boehringer or Impax? Interestingly, a news piece by is suggesting that Ranbaxy may likely to receive one-time payment for enabling the launch of generic version in the US market, and also that Ranbaxy itself allowed Boehringer to bring in Impax for launching generic Flomax.


  1. The very premise of the blogpost is wrong. The patent expired in October 2009. There was no 180-day exclusivity on this product.

  2. The original patent expired in October 2009.Including the additional paediatric exclusivity of additional 6 months, it expires on April 27. Both Ranbaxy and Impax had 8th weeks exclusivity .. Can some one clarify if Ranbaxy could not launch the drug, does the 2nd applicant (apparently Impax in this case) automatically gets the FTF status and thus enjoy the exclusivity..

  3. Firstly, I don't think the blogpost anywhere talks about the patent expiry date rather than the date on which generic product was supposed to be launched (date as per the waiver in settlement agreement) by applicant, hence no mean to decide the premises of Blogspot here.

    First thing that I am sure about is: forfeiture applies only for all “first applicants” and hence subsequent applicants are not subject to exclusivity. If all first applicants forfeit exclusivity, subsequent applicant does not inherit 180-day exclusivity.
    As we see that all Ranbaxy course of action (Including settlement agreement) completed even before the Impax fled its ANDA and therefore atleast this point of time Ranbaxy’s agreement with Impax can not be understood. If Ranbaxy had any such strategy in mind, it would have gone to make such agreements with Innovator and why would with Impax or involve Impax with them.
    About 180 days exclusivity, it would never be prudent for Ranbaxy to lose the exclusivity and allow Impax to launch. Further as Innovator agreed with Impax to allow it launch before patent expiry, certainly there were no exclusivity issue. Hence Ranbaxy had, at that point of time, anyhow forfeited the exclusivity or simply had no exclusivity.(Now the position over how the forfeiture occurred is not clear. Wether a decision court decision would trigger the exclusivity & that Ranbaxy did not have final approval by that date and hence lose the exclusivity. When none of either 75 days after final approval or court decision occured, how it forfeited?will anyone clear??)
    Assuming that as Ranbaxy had already forfeited the exclusivity, final approval was taking time and it had remained with option to launch along with Impax only(same day). Here there are chances that Ranbaxy had entered in some agreement with Impax and withdrew its pursuance for final approval.

    In such situation, we may guess, If pre-patent expiry launch exclusivity were the only promised benefits by Innovator to Ranbaxy in their settlement agreement and Ranbaxy had entered in agreement with Impax, certainly these were the benefits that may have transferred into one-time payment or like.
    Only in worst scenario, the Ranbaxy’s point of not getting timely approval a reason for its failure to launch is admissible and that Ranbaxy had really failed to receive anything.

  4. Thank you for your valuable comments.

    Thanks for bringing me in notice that patent already expired in October 2009 and there was no 180-day exclusivity for this product. Highly appreciated and may be next time I too can be as diligent as you are.

    Under the US laws, patent term extension and pediatric exclusivity do not have separate validity period it simply add more days to the US patent term unlike Europe where patent and exclusivity (SPC/pediatric) have separate legal validity period, i.e. SPC/pediatric exclusivity come into force only after the expiry of patent. So in case of Flomax, the patent expiration date will be calculated after adding six months pediatric exclusivity, i.e. April 27, 2010 (not the original expiration date, i.e. October 27, 2009).

    Secondly, 8 weeks early marketing period is not any sort of exclusivity. It is early launch period that the Innovator allowed both Ranbaxy and Impax to market their generic products (possibly providing license to listed patent or may be under agreement not to sue for patent).

    Lastly and more importantly, FTF status is always with first generic applicant to file paragraph IV. It cannot be transferred to subsequent generic applicant. It is statutory provided exclusivity strictly granted to FTF applicant only. In this case, if Ranbaxy lose 180-day exclusivity then it simply means there will be no 180-day exclusivity for Flomax.

    Fundamentally if there is a company having 180-day exclusivity for an approved product then the USFDA cannot approve subsequent ANDAs until and unless the FTF applicant have either completed or forfeited the 180-day exclusivity period. In Flomax case, Ranbaxy is having FTF status which mean entitled to 180-day exclusivity even after out-of-the-court settlement with the Innovator. Ranbaxy can only forfeits 180-day exclusivity if

    (a) it does not market the product within 75 days (i) from the date of FDA final approval, (ii) after final decision of invalidity or non-infringement, (iii) a settlement or consent of invalidity or non-infringement, or (iv) withdrawal of patent information by NDA applicant (this condition is not applicable because Ranbaxy haven’t received the final approval, also there is no court decision of invalidity or non-infringement or settlement or consent of invalidity or non-infringement, and further there is no withdrawal of patent information by NDA applicant)
    (b) it withdraws the ANDA (this condition is also not applicable because Ranbaxy still have their ANDA with the USFDA for approval process)
    (c) it withdraw the paragraph IV certification (may be or may be not – no information available in public)
    (d) it fails to obtain tentative approval within 30 months from the date of filing of ANDA (not applicable because Ranbaxy well in time received the tentative approval)
    (e) it enters into an anti-competitive agreement (may be or may be not – no information available in public)
    (f) all applicable patents expires (not applicable because patent is valid as of date)

    Further the USFDA can also forfeit 180-day exclusivity if –

    (a) ANDA was withdrawn (this condition is not applicable because the ANDA is still in process)
    (b) First filer deleted paragraph IV certification (may be or may be not – no information available in public)
    (c) The listed patent expired (patent is valid as of date)
    (d) First filer was not diligent (?? No idea regarding this – there is no information made public by USFDA why Ranbaxy ANDA not got approved)

    In nutshell, the USFDA cannot approve the Impax generic Flomax until and unless Ranbaxy had completed (which is not the case here) or forfeited (which is likely the case) its 180-day exclusivity except in the case where Impax product is approved as authorized generic by the Innovator. Remember authorized generic is not barred by 180-day exclusivity.

    I hope my post is comprehendible enough not to create any sort of confusion.

  5. Indeed a comprehensive feedback.

    But what can be presumed, whether: Ranbaxy really missed the race by not having approval (after that it had Tent approval 2.5 yr back) or it could just be a strategy to willingly not to be diligent in pursuing the ANDA as it might have entered into any short of agreement with Impax (as both were supposed to launch on same date)(best possible deal that Ranbaxy will clinch after lose the 180-exclusivity and not seeing timely approval)

    Whether last year FDA letters to Ranbaxy for violating the required quality standards would impact the approval process ( or is the sole reason behind this event)?

    Since in your initial post you asked" Often strategic business moves are played within the closed walls of the Management Boardroom" & suspected of possibilities for enter-party agreements, i am still sitting to think about "what could actually be the reason or, if there were, then what could be the agreements and which parties were in agreement.

    The thing that initiates me to raise this possibility a & a is that "Ranbaxy won't let go such chance so easily or for no penny, atleast.

  6. FDA lawblog reports patent expiry as the reason for forfeiture??

  7. Actually its quite simple. To launch, you need FDA approval. As far as BI was concerned- it was offering the same settlement date to both which is 02 March. However Ranbaxy's exclusivity would have prevented Impax to get FDA approval until October even though from BI they had a go-ahead. Even on Sumatriptan, GSK had allowed Cobalt to come to market two months after us. But Ranbaxy and Teva had exclusivity and Cobalt couldn't get approval until 180 days went away.

    In Tamsulosin, Ranbaxy's attempts to site-transfer the product to Ohm got delayed as it got delayed in Sumatriptan. But, unlike Sumatriptan, Tamsulosin was post-MMA and hence the new forfeiture conditions kicked in and they forfeited exclusivity when they didn't receive tentative or final approval in 30 mths. Impax was prepared and launched. Now on Fosamax D, Teva is set to forfeit exclusivity if they don't get approval by May 20th.

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