Competition Is Likely To Be Fierce Upon Molecule Patent Expiry Of Rabeprazole

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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 Janssen, Johnson & Johnson and Eisai’s proton pump inhibitor Rabeprazole (Pariet® and Aciphex®). Rabeprazole products global sales dropped 7.5% in 2011 to ¥136.9 billion.

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

  •     Patent protection for the Rabeprazole molecule expired in Canada at the end of 2007, protection extends to May 2013 in the US, and maximum 5 year extensions have been granted in Australia as well as most major markets in Europe, extending protection on these patents to November 2012.
  •     The validity and enforceability of the US patent was upheld after challenges from Dr Reddy’s and Teva.
  •     Two later patent families claim oral preparations consisting of a core containing an acid-unstable benzimidazole compound and two coating layers, the outer being an enteric polymer film. A second later patent family claims a multiple unit tablet comprising pellets of an acid susceptible proton pump inhibitor covered with an enteric coating layer which separates it from the other components and a third patent family claims an oral formulation comprising granules having an inert core coated with a benzimidazole, then with an outer enteric coating layer which is separated from the inner later by ingredients preventing degradation of the enteric coating. Patents within these families are not considered to be a constraint to generic competition because the protected technology is likely to be circumvented.
  •     Data exclusivity has expired in all major territories.
  •     Amongst the US approvals, tentative FDA approvals have been identified for generic Rabeprazole Sodium, awarded to Teva and Mylan.
  •     In the UK, generic authorisations have been awarded to Actavis, Caduceus, Chemo Iberica, CT Arzneimittel, KRKA, Ratiopharm, Teva, Torrent and Winthrop is indicative of the likely competition Rabeprazole will face across Europe upon SPC expiry.
  •     A diversity of applicants represented by the significant portion outside the top five have been identified as filing patent applications relating to Rabeprazole, focusing primarily on formulation form and process patent applications. There is also a prominence of relevant applications filed by manufacturers of competing proton pump inhibitors, Takeda (Lansoprazole, Dexlansoprazole) and AstraZeneca (Omeprazole, Esomeprazole).
  •     Prior to launch of Rabeprazole large numbers of patent filings relate to similar proton pump inhibitors and are filed by generic and innovator companies, these allow generic competition onto the market immediately after molecule patent expiry for this later ‘me-too’ product.
  •     After launch, generic companies had a strong responsive patenting, particularly in the area of formulations.

GenericsWeb notes that: “The API patent remains in force in most major territories and means there still exists a significant barrier to generic competition. The number of generics available in Canada, the first of which were authorised immediately after Canadian molecule patent expiry, the significant number of marketing authorisation holders identified in the UK and the presence of Paragraph IV filings observed in the US is indicative of the interest shown by generic companies for Rabeprazole generics. Although this compound is difficult to formulate and the innovator has some patents protecting specific marketed formulations, these are not difficult to circumvent given the prior art landscape that exists as a result of development of other, similar compounds. Generic competition for Rabeprazole is therefore likely to be very strong upon molecule patent expiry.”

You can read the entire article here at:

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

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Yoann Bretonnet
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