Novartis’ Blockbuster Zoledronic Acid – Overview of IP Situation and Litigation

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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 Zoledronic Acid. Marketed by Novartis, Zoledronic Acid is indicated for the treatment of oncology-related bone conditions (Zometa®) and non-oncology related bone conditions (Reclast®/Aclasta®) with reported global sales of USD $1.5bn and USD $580m in 2010 respectively.

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

  • Zometa (4mg/5mL) and Aclasta (5mg/100mL) are currently available for intravenous (IV) administration, the frequency of administration depending on the indicated bone condition under treatment.
  • Both Boehringer Mannheim/Roche and Novartis are the registered patentees of two patent families which protect the Zoledronic Acid molecule with over three months between their respective priority applications.
  • Molecule protection for the earlier Boehringer Mannheim patent family remains in force in Europe via Supplementary Protection Certificates (SPCs) and a national patent term extension in Australia until July 2012, and early 2014 in Canada. Equivalent protection has already expired in the US.
  • In most major European territories, SPCs also protect the Zoledronic Acid molecule in Novartis’ later molecule patent family with SPCs expiring in November 2012. Novartis has successfully complied with the measures in agreed paediatric investigation plans (PIP) and has been awarded 6 month extensions to the terms of the SPCs, giving an expiry of May 2013. National patent term extensions have also been granted in Australia and the US with expiries of November 2012 and May 2013 respectively.
  • In all major territories where Zoledronic Acid has been marketed, the data and marketing exclusivity have already expired and are not a factor for generic competition.
  • In the US, tentative FDA approvals for generic Zoledronic Acid have been granted to Apotex, Bedford, Emcure, Hospira, Pharmaceuticals International, Pharmaforce, Sun and Teva.
  • Paragraph IV filings have been identified relating to generic Zometa and Reclast however litigation was resolved after Teva discontinued a patent challenge and agreed to not launch Zoledronic Acid in the US until expiry of Novartis’ molecule patent.
  • Generics company Teva appears in the top five applicants for patents relating to Zoledronic Acid.

GenericsWeb notes that: “In summary, Novartis’ protection remains in force for the Zoledronic Acid molecule in Europe as a result of SPCs and extended patents in other major territories and as such represents a barrier to generic competition. Considering the global sales of Zoledronic Acid the expiry of this molecule protection means that generic competition will undoubtedly be very strong once molecule protection expires, provided later filed patents are not granted in a manner where the claims cannot be circumvented.”

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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