The newspaper reported that sanofi’s generic drugmaker Zentiva will be allowed to produce Lipitor’s active ingredient atorvastatin in France.

Sanofi bought the Czech generics maker Zentiva back in 2008 for US$2.6 billion and brought all of its European generics activities under the Zentiva brand in April 2011. This created, according to sanofi, the third largest generics company in the European market and more importantly the fastest growing [1].

Sanofi confirmed that it had signed a licence agreement to manufacture atorvastatin, marketed as Tahor in France. But added that ‘sanofi respects Pfizer’s patent rights and will not launch the product before 7 May 2012, after expiry of the supplementary patent certificate with paediatric extension.’

The deal, which will only allow Zentiva to produce generic atorvastatin in France, is part of France’s Strategic Council of Health Industries (CSIS) programme, a cooperation agreement between business and government. The programme gives the original drugmaker a tax break if it allows a generic drugmaker to produce and sell cheaper generic versions as the brand-named drug’s patent expires. The CSIS agreement is designed to keep production sites and employment in France.

Similar deals were signed in 2010 with Merck Sharp & Dohme-Chibret (MSD-Chibret) and with US drugmaker Eli Lilly. MSD-Chibret signed an agreement with Fareva for the production of a generic version of its anti-asthmatic product Singulair (montelukast), whose patents will expire in France in early 2013. While the Eli Lilly deal allows Delpharm to produce a generic version of its anti-psychotic drug Zyprexa (olanzapine) for which the patent will expire at the end of September 2011 [2].

Sanofi has made generics one of its growth areas as several of its brand-named drugs lose their patents and the agreement is in line with sanofi’s strategy to become less dependent on patents and develop its generics business, according to a French analyst.

There is much at stake. In 2010, Lipitor had worldwide sales of US$13 billion, accounting for 15.8% of Pfizer’s total revenue [3]. Sales in France, however, are estimated at just Euros 465 million, and since sanofi will not be launching the drug before the patent’s expiry, it will also face competition from other generic drugmakers.

In the US, Lipitor’s patent expires on 30 November 2011, at which stage both Ranbaxy Laboratories and Watson are expected to launch generic versions.

Indian generics manufacturer Ranbaxy reached an agreement with Pfizer in 2008, giving it a licence to sell atorvastatin in the US as of 30 November 2011 [4]. The deal also licensed Ranbaxy to sell generic versions of atorvastatin, starting on different dates, in several other countries including Australia, Belgium, Germany, Italy, The Netherlands and Sweden.

The Daiichi Sankyo subsidiary will also have exclusivity for 180 days before other drugmakers can enter the market due to its first-to-file with the FDA status. That is if Ranbaxy can solve its good manufacturing practice problems at its Dewas and Paonta Sahib plants in India and get its generic atorvastatin approved by the FDA in time [4].

Watson Pharmaceuticals will start selling a so-called authorised generic atorvastatin manufactured by Pfizer in the US from 30 November 2011, under an agreement that runs for five years.

Related articles

Pfizer seeks 6-month paediatric exclusivity for Lipitor

Ranbaxy launches generic atorvastatin in South Africa

References

1. GaBI Online - Generics and Biosimilars Initiative. Branded generics and generics branding for Merck and sanofi-aventis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 September 09]. Available from: www.gabionline.net/Generics/News/Branded-generics-and-generics-branding-for-Merck-and-sanofi-aventis

2. GaBI Online - Generics and Biosimilars Initiative. MSD-Chibret signs generics deal with French manufacturer [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 September 09]. Available from: www.gabionline.net/Reports/MSD-Chibret-signs-generics-deal-with-French-manufacturer

3. GaBI Online - Generics and Biosimilars Initiative. Pfizer seeks 6-month paediatric exclusivity for Lipitor [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 September 09]. Available from: www.gabionline.net/Generics/News/Pfizer-seeks-6-month-paediatric-exclusivity-for-Lipitor

4. GaBI Online - Generics and Biosimilars Initiative. Ranbaxy may sell its generic atorvastatin exclusivity [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 September 09]. Available from: www.gabionline.net/Generics/News/Ranbaxy-may-sell-its-generic-atorvastatin-exclusivity