Which products are pharma companies filing for registration in poorer countries?

• Many on-patent medicines are not widely filed for registration, compared to on-patent vaccines

• Only three companies have registered any of the patented medicines in scope in any low-income countries

On-patent antibiotics and antifungals are typically indicated for very specific cases or complicated infections, and are targeted at smaller patient populations.

Due to their more restricted use, companies have a lower expectation that they will gain a high return on investment, and can find it difficult to estimate the number of people who could benefit from those medicines in LMICs.

Although volume expectations are lower than for high-volume generic medicines or vaccines, companies need to continue to register their patented antibiotics and
antifungals, especially those which do not benefit from pooled procurement mechanisms, as this is the first step in providing long-term access for patients in low and middle-income countries.

Only three companies – Johnson & Johnson, Pfizer and Viatris – have registered any of their patented medicines in the 34 countries defined as ‘low-income countries’.

• MDR-TB* medicine bedaquiline (Sirturo) is approved in seven low-income countries (Democratic Republic of Congo, Burundi, Ethiopia, Rwanda, Tanzania, Uganda and Zimbabwe).

• Ceftazidime/avibactam (Zavicefta), used to treat complicated intra-abdominal infections, complicated urinary tract infections (cUTIs) and hospital-acquired pneumonia, is approved in three low-income countries (Ethiopia, Tanzania, and Uganda).

• M/XDR-TB** medicine pretomanid has been fi led for registration in five low-income countries (Democratic Republic of Congo, Ethiopia, Mozambique, Tajikistan and Zimbabwe).

While Johnson & Johnson and Viatris have filed their TB medicines in countries with a high TB burden, Pfizer reports that it has filed in these countries based on local patient and provider needs.

As a group, vaccines are more widely filed than medicines

Vaccines have a major role to play in curbing AMR, because they can decrease the number of cases of infectious diseases, and thus decrease antibiotic use. This slows down the emergence and spread of AMR.

Vaccines are more likely than medicines to be filed in a broad range of countries, in part because many of them have been on the market for longer than on-patent medicines. 

Vaccines can also represent a secure long-term financial opportunity for companies, because they cover broad populations (e.g. through national immunisation programmes) and can benefit from pooled procurement mechanisms such as Gavi, The Vaccine Alliance. 

Pharma companies can also benefit from long-term patent protection for vaccines; some of the vaccines considered in this analysis were first approved more than 20 years ago. 

Which off-patent/generic products are filed most widely?

The Benchmark looks at the off -patent/generic medicines with the highest volume of sales. The number of registration fi lings varies greatly by access category. 

Access and watch antibiotics (defined according to the WHO’s AWaRe classification) are filed for registration much more widely than reserve antibiotics (16 access countries on average), because they are more widely used and represent a higher sales volume for companies.

Reserve antibiotics are largely overlooked by pharmaceutical companies. Although they should only be used as an option of last resort and can thus represent fewer financial incentives for companies, reserve antibiotics are also essential for controlling some of the most resistant pathogens. Yet, they are filed in only two out of 102 access countries in scope on average. 

Of the products in scope, only 39% of off -patent/generic medicines supplied by large research-based companies are filed in more than 10 access countries. For products in scope which are marketed by generic medicine manufacturers, that number drops down to 29% filed in more than 10 LMICs.

Methodology: products in this analysis

Within each access category, each company’s top two off -patent products by sales volume were selected for analysis, using IMS global sales data. These categories are Access, Watch, Reserve (AWaRe), antifungals, and antituberculosis. However, off -patent/generic TB medicines were removed from the analysis because they did not meet current TB treatment guidelines

Which off-patent/generic products are filed most widely?

Of the products in scope, these graphs show the five most widely filed off-patent/generic medicines targeting bacterial and fungal infections, broken down per the AWaRe classification, as well as antifungals.

N.b., off-patent/generic products (such as older antibiotics like amoxicillin) are often produced and sold by multiple different companies, which means that the same product’s INN (International Nonproprietary Name) can be registered several times.

*** MSD declined to provide information about these products to the Benchmark. Information about where products are registered is used by governments, NGOs and others to inform procurement decisions. Generic medicine manufacturers also use such information to inform decisions about where to expand their business operations.

† Sales volumes specific to low- and middle-income countries are not reflected in global sales data.