Please login to the form below

Not currently logged in
Email:
Password:

BMS wins six more months for Plavix

Bristol-Myers Squibb and sanofi-aventis have won an additional six months of US marketing exclusivity for their blood-thinner Plavix

Bristol-Myers Squibb (BMS) and sanofi-aventis (S-A) have won an additional six months of US marketing exclusivity for their blood-thinner Plavix (clopidogrel bisulfate), which is the world's second-best-selling drug and brought in $9.1bn in global sales in 2009, with $5.6bn of that total generated in the US.

The companies have been granted the additional exclusivity through the US Food and Drug Administration's (FDA) paediatric exclusivity programme. The programme awards drug manufacturers an additional six months without generic competition in return for conducting paediatric studies of their products at the agency's request, as data on medicines in children is often scarce.

In this case, the FDA requested that the companies study Plavix in infants with heart defects. The study, which was conducted by BMS and enrolled more than 900 babies, failed to show a benefit for the drug. However, the paediatric exclusivity programme rewards companies for conducting studies whether or not the outcome is successful.

Plavix had been scheduled to lose patent exclusivity and become vulnerable to lower-cost generics by November of this year. However, because paediatric exclusivity attaches to the end of existing patent periods rather than running concurrently, the FDA will now hold off on allowing generics to come to market until May 17, 2012.

The extension on the exclusivity of the mega-blockbuster drug is a bright spot for BMS and S-A, both of which are struggling with the effects of generic competition for other key products. S-A's deep vein thrombosis treatment Lovenox (enoxaparin) recently lost its US exclusivity, and Bristol-Myers has five major products that will go off patent before 2015.

31st January 2011

Share

PMEA Awards 2020

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Lucid Group Communications Limited

WE’RE ON A MISSION To enhance patients’ lives through communication that changes behaviour and improves patient health outcomes....

Latest intelligence

#DemandDiversity: For International Women's Day, we ask... why do women often suffer from more side effects than men?
Women are largely prescribed exactly the same treatment regimens as men, with no account for the underlying differences in physiology and drug metabolism between the sexes....
Good design saves lives
Good design and creative thinking are essential if we are to improve on existing problems in new ways, which is why design and creativity within healthcare is vital. Health is...
Why you must understand the pricing of patient recruitment companies
Recruiting a diverse range of patients and engaging with them for your clinical trial isn’t an easy task, which means you might turn to patient recruitment companies, like us, who...

Infographics