GenericsWeb Analyses Opportunity for Generic Docetaxel

Share Article

GenericsWeb, the leader in established pharmaceutical patent analysis and searching, recently published an article that analyses opportunities in launching generic versions of Taxotere® (Docetaxel).

Based on its proprietary Pipeline Patent Intelligence, GenericsWeb reveals that the patent protection for the Docetaxel molecule in US and European countries expired in November 2010, however the innovator, Sanofi-Aventis now relies mainly on key formulation patents to protect its Taxotere market from generic erosion.

Taxotere® (Docetaxel), marketed by Sanofi-Aventis, is indicated for the treatment of many types of cancer, sometimes in combination with other active agents. Docetaxel is considered the largest oncology product ever developed, with global market value at $3 billion in 2009.

The article by GenericsWeb highlights the following observations in regard to generic Docetaxel products:

  •     Patent protection on the Docetaxel active ingredient has now expired in major markets, yet some do not yet have generic competition.
  •     Patent protection remains in force in many countries in respect of specific elements of the ‘twin vial’ dosage form, which may prevent its launch for an additional 2-3 years beyond molecule patent expiry. These patents have been subject to legal challenges.
  •     Generic Docetaxel launch has only been observed in countries where the single vial dosage form exists and/or where patents on the twin vial do not exist or have expired.
  •     Patent protection also remains in force in many countries in regards to the combined use of Docetaxel with other active ingredients, and may affect the indications carried on generic products.

“As the commercial single vial system of the Taxotere product does not appear to be protected by any later-expiring key formulation patents,” commented John He, author of the article, “an opportunity exists to launch the single vial system upon expiry of the molecule patent in Europe, but perhaps not elsewhere, where the single vial dosage form is not authorised.”

“The lifecycle management strategy employed by Sanofi-Aventis appears to be paying dividends,” said GenericsWeb CEO Leighton Howard. “Some smart product development and IP protection is buying the innovator extra time to reap the rewards of its monopoly,” he continued.

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

# # #

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Yoann Bretonnet
+61 2 9262 7696
Email >
Visit website