Generic drug manufacturers
Cadila Healthcare secured the highest number of ANDA (abbreviated new drug application) approvals among Indian pharmaceutical companies during the past nine month period.
The country’s fourth-largest drugmaker by market cap has received 70 ANDA approvals in the current financial year (Image 1). Out the total, 21 ANDA approvals were received by the company during the previous quarter.
The drug makers are required to obtain ANDA approval from the FDA to manufacture and market the low-cost generic alternative to the brand-name drug in the US market.
French drug-maker Sanofi faces risk to its 16% of revenues after its top-selling drug Lantus came under threat from the generic manufacturers. The fear of losing revenue from Lantus has forced Sanofi to defend its intellectual property rights. Recent news flow showed that the maker of Lantus drug filed several patent infringement suits against the generic manufacturers.
Lantus, an “Insulin glargine” (a long-acting basal insulin analogue), accounted for 16.4% of Sanofi’s net sales in 2016. Lantus consists of microcrystals, which slowly releases insulin over a period of 24 hours with a peak-less profile. This drug helps in controlling the blood sugar of diabetic people.
Lantus is one of the major drugs in the anti-diabetic segment. In 2015, Lantus accounted for ~17% of the global sales for anti-diabetic products.
Patents on drugs worth over USD 200 billion are going to expire in the next 5-years, according to a study conducted by Heckyl. More than 330 drugs will lose patents issued by the US Patent and Trademark Office during CY2018-2022. These drugs constitute ~38.5% of the total number of patented drugs in the US.
A slew of impending patent expirations in the US offers a huge opportunity for generic drug manufacturers. The key beneficiaries of upcoming patent expiries are Mylan, Teva, Celgene, Wockhardt, Dr Reddy’s, Cipla, Lupin, Aurobindo, Natco and Cadila.