Roche’s Proactive Stance in Protecting its Top Selling Bisphosphonate – Ibandronic Acid

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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 equivalents of Roche and GSK’s top-selling bisphosphonate Ibandronic Acid. Ibandronic Acid products had reported global sales of CHF 1bn in 2010.

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

  •         Ibandronic Acid is currently available as film coated oral tablet and solution for intravenous injection formulations. Currently, the Bonviva®/Boniva® monthly 150mg oral tablet and the Bonviva®/Boniva® quarterly 1mg/mL intravenous injection formulations of Ibandronic Acid are indicated for the treatment of postmenopausal osteoporosis.
  •     In some countries outside of the US, Bondronat® formulations of Ibandronic Acid (available in 50mg tablet and 2/6mg infusion concentrate) are indicated for the prevention of skeletal events in patients with breast cancer and bone metastases, and the treatment of tumour-induced hypercalcaemia.
  •     Patent protection of the Ibandronic Acid molecule remains in force in Australia and the US via national patent extensions until July 2012 and March 2012 respectively. In Canada molecule patent protection expired in March 2009.
  •     In several European states, molecule protection was extended via Supplementary Protection Certificates (SPCs) until June 2011.
  •     Roche also has a later patent family with expiries of May 2023 which generally protects the use of Ibandronic Acid in the treatment of osteoporosis by monthly oral administration of a single dose of 150mg of Ibandronic Acid. Patents within this family are generally constraining for the Boniva 150 mg dosage form and its osteoporosis indication.
  •     Opposition proceedings against a granted European patent within this later patent family were brought by several generic companies, the proceedings of which are on-going. US equivalents in this family have also been challenged through the courts with little success. Since the 150mg oral tablet only carries the osteoporosis indication, patents in this family will block generic competition for this dosage form until May 2023 unless successfully challenged. The 2.5mg and 50mg tablet strengths are generally not constrained by this patent family so may face competition where a generic approval route is available.
  •     In all major territories where Ibandronic Acid has been marketed, the data and marketing exclusivity expired before molecule patent protection and as such was not a factor for generic competition.
  •     In the UK and EU, a variety of generic marketing authorisations relate to all dosage forms and strengths, however some of these are unlikely to be commercialised until the relevant patents expire or have been revoked.
  •     Amongst the US approvals, tentative FDA approvals have been identified for Ibandronate Sodium. Following Paragraph IV filings for generic Boniva, extensive patent litigation has been identified between Roche and Actavis, Apotex, Cobalt/Watson, Dr Reddy’s, Genpharm, Mutual, Orchid and Teva.

GenericsWeb summarises that: “Molecule protection remains for the Ibandronic Acid molecule in certain major territories, but this is set to expire in the next 12 months. Evidence of potential generic Ibandronic Acid competitors can be seen via marketing authorisations, however Roche have protected their 150mg oral dosage form well by patenting its use for osteoporosis, thus preventing a variety of generic competitors from launching an equivalent to what is likely to be their biggest selling dosage form until 2023. It is possible that some erosion of sales from this dosage form will be experienced as generic competitors launch 50mg dosage forms upon molecule patent expiry, these generic versions being prescribed or dispensed instead of the brand 150mg product where legal. Considering the vast global sales of bisphosphonates, generic manufacturers will undoubtedly be closely watching the patent landscape surrounding Ibandronic Acid, the outcome of its on-going litigation and opposition, and any future developments in its lifecycle.”

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

About GenericsWeb – The Search is Over
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
GENERICSWEB
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