Duloxetine Competition Expected to be Strong Upon API Patent Expiry

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GenericsWeb, the leader in established pharmaceutical patent analysis and searching, recently published an article based on its proprietary Pipeline Patent Intelligence that analyses opportunities in launching generic versions of generic Duloxetine equivalents of Eli Lilly’s blockbuster serotonin-norepinephrine reuptake inhibitor (SNRI) (Cymbalta®, Andepra®, Ariclaim®, Xeristar® and Yentreve®). Global Cymbalta® sales generated US$4.16 billion in 2011.

The article by GenericsWeb highlights the following observations in relation to generic Duloxetine:

  •     Duloxetine molecule was discovered and marketed by Eli Lilly and was co-marketed and developed under a collaborative agreement with Boehringer Ingelheim (excluding the US and Japan) until March 2010.
  •     Protection extends to December 2013 in the US courtesy of a 6 month paediatric extension to the 5 year s156 term extension.
  •     The maximum 5 year patent term extensions have been granted in Australia and most European markets, extending patent protection for the API until December 2012.
  •     Data exclusivity constraints in Europe extend beyond the expiry of patents in the API family, preventing applications for a generic MA until August 2014.
  •     In Canada, data and market exclusivity periods should prevent the launch of a generic MA until May 2016.
  •     In Australia, the launch of generics is potentially delayed beyond the expiry API patent protection in December 2012 as sponsors wait for approval of their MA.
  •     Patent families protecting approved indicated uses for Duloxetine and another family claiming the treatment of urinary incontinence are considered to be a constraint for those uses.
  •     Granted SPCs in most ‘Core’ European countries, except Germany where the application has lapsed, extend Eli Lilly’s monopoly for Yentreve® and prevent generic companies launching products carrying that indication until August 2019.
  •     Amongst the US approvals, tentative FDA approvals have been identified for generic Duloxetine hydrochloride, awarded to Impax Labs, Lupins Pharms, Zydus, Sun Pharma, Wockhardt, Torrent Pharms, Sandoz, Aurobindo Pharma, Dr Reddy's Lab and Teva
  •     Generic competitor Teva is the highest individual filer in the top five, their patenting activities focusing primarily on molecular form, process and formulation.
  •     By post-approval, Generic companies consistently patented in the area of molecular form, process and formulation.

GenericsWeb notes that: “Eli Lilly’s protection remains in force in the US until December 2013 after its validity and enforceability was upheld, but competition will be strong upon expiry of the extended patent term. Data exclusivity is the major constraint to generic entry in Europe and Canada, extending beyond API patent protection. Data protection provisions in Australia may delay launch of generics until after expiry of API patents, with a likely launch date in mid-2013. Further patenting strategies by Eli Lilly will lead to generic competitors having to carve out indications and patenting of processes will make API synthesis complicated without a good picture of the patent landscape. Innovator formulation patents are likely to be circumvented as evidenced by patent filing trends and the volume of generic competitors holding tentative FDA approvals expected to launch upon expiry of the API patent in the US, however caution should be exercised when circumventing innovator formulation patents, as many formulation patents are held by generic competitors, underscoring the importance of developing an IP strategy earlier in the development process.”

You can read the entire article here at: http://www.genericsweb.com/druginfocus/Duloxetine

GenericsWeb, the leader in pharmaceutical patent analysis and searching holds an impeccable track record in providing quality patent information, and has allowed numerous pharmaceutical companies to successfully navigate intellectual property hazards. GenericsWeb is headquartered in Sydney, Australia, with offices in North America and Europe. All staff are highly skilled and experienced internationally and have extensive experience in pharmaceutical sciences and patent searching. For more information, visit the company's web site at http://www.genericsweb.com

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Yoann Bretonnet
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