Most off-patent products filed for registration where need is highest

Companies:

Abbott, Cipla and Mylan

Topic:

Product registration

What:

New medicines cannot be made widely available until companies register them. Three companies stand out for filing all of their highest-volume off-patent antibacterial and antifungal medicines (a total of 30 products) in at least one access country. Access countries are 102 low- and middle-income countries with a high burden of disease and high need for greater access to medicine.

Region:

74 access countries

Whether new products are available and affordable to those in need depends on the choices pharmaceutical companies make when registering,  pricing and distributing their products. Ensuring access to off-patent products may require companies to take a different approach to that from on-patent products. Factors that currently affect access to off-patent antibacterial and antifungal medicines are multiple and include fragmented supply chains and limited availability of active pharmaceutical ingredients (APIs). Further, off-patent products are less likely to be registered in low- and middle-income countries compared to upper-middle-and high-income countries where, in general, markets are larger and healthcare systems are more robust. 

What are 'access countries'?
The Benchmark has identified 102 low- and middle-income countries where greater access to antibacterial and antifungal medicines are needed, referred to as 'access countries'. Companies face disincentives to register their high-volume products in access countries such as limited local regulatory resources, low-volume markets, political instability or conflict, and economic sanctions, but registration is an important first step in helping to prevent disease and contain antimicrobial resistance.

How do three companies stand out from the pack?
Abbott, Cipla and Mylan demonstrate best practice, having filed all of their highest-volume off-patent antibacterial and antifungal medicines (a total of 30 products) in access countries. Abbott is the generic medicine manufacturer with the most widely filed off-patent product (looking at registrations in access countries). Its antibacterial medicine clarithromycin is filed for registration in 60 access countries. Cipla’s most widely filed product is the antifungal fluconazole (21 countries); and Mylan’s most widely filed product is the antibacterial medicine ceftazidime (10 countries). All of these products are among the companies’ highest-volume antibacterial and antifungal medicines. 


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