The following is excerpted from an August 23, 2011 GenericsWeb press release:
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 Atacand® (Candesartan cilexetil). Marketed by AstraZeneca and Takeda, Candesartan cilexetil is indicated for the treatment of hypertension and heart failure, with sales of US $1.5bn in 2010. Candesartan cilexetil is currently available in oral tablet formulations and in oral tablet fixed dose formulations in combination with Hydrochlorothiazide (Atacand HCT®).
The article by GenericsWeb highlights the following observations in relation to generic Candesartan:
• Patent protection of the candesartan cilexetil prodrug molecule remains in force in Europe via Supplementary Protection Certificates and national patent extensions in other major territories until 2012-2013.
• Patent protection has expired in Canada and generics are available from Apotex, Sandoz and Teva, and generics have been identified in Australia despite the extended molecule patent remaining in force.
• In all major territories where Candesartan has been marketed, the data and marketing exclusivity have already expired thus are not a factor for generic competition.
• Patents protecting the combination product with Hydrochlorothiazide (HCTZ) are identified in Canada, Europe and the US; however the granted European equivalent has recently been revoked and the Canadian patent is undergoing litigation.
• In the US, tentative FDA approvals for generic Atacand have been granted and several Paragraph IV filings have been identified relating generic Atacand and Atacand HCT.
• Generic companies KRKA and Teva appear in the top five applicants for patents relating to Candesartan.
• Since the initial and on-going approvals of Atacand HCT, several generic companies have submitting patent filings relating to combination products and their various uses.
GenericsWeb notes that: “Currently a barrier to generic competition, the expiry of the prodrug molecule patents in 2012 in Europe and the US means that generic competition to Candesartan is likely to be very strong, evidenced by the fact that generic Candesartan appeared in Canada only days after the expiry of the Canadian molecule patent.”
Generic combinations of Candesartan cilexetil and HCTZ may be prevented until 2014; however this will depend on the outcome of litigation in Canada, which is currently on-going. Since the revocation of the equivalent European patent, the outcome of new pending European applications concerning the combination is of great importance when considering generic Atacand HCT, as these are unlikely to proceed unopposed by major generic manufacturers.”
You can read the entire article here.