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.
FiND, an alternative data platform developed by Heckyl, captured patents related news items for Lantus (See image 1 below).
Lantus has contributed USD 36.7 billion in sales to Sanofi during 2012-2016. Sanofi has recorded the highest sales of USD 8.37 billion for Lantus in 2014. However, in the subsequent years, sales of Lantus dropped after Eli Lilly launched its own version for Sanofi’s top-selling drug. In 2016, Sanofi has generated sales of USD 6.33 billion for Lantus, down USD 2 billion from 2014 level (See image 2 below).
During the first half of 2017, Lantus recorded a drop of 18% in sales on a year-on-year basis to USD 2.6 billion. (See image 3 below). The pickup in sales of Basaglar, Eli Lilly’s biosimilar of Lantus had impacted Sanofi in the first half of 2017.
Eli Lilly has launched Basaglar after reaching a settlement with Sanofi in 2015. The launch of Basaglar helped Eli Lilly to book revenue of USD 130 million during the first half of FY17 (See image 4 below).
On the other hand, Merck Inc has also secured approval for Lantus biosimilar. However, the company will not be able to launch the drug until 2019 as the 30-month stay period under the Hatch-Waxman Act started ticking in from September 2016.
FiND captured regulatory related news items highlighting FDA approval to Merck Inc for the biosimilar of Lantus (See image 5).
Sanofi has 24 orange book listed patents for Lantus expiring mostly in 2023, 2024 and 2028 (See image 6 below).
With only one marketed rival for Lantus, the discounting to the brand has remained limited. However, going forward, Sanofi could see a bigger drain to its Lantus revenue with the entry of new players in this drug. In this context, Sanofi will likely maintain its aggressive stance on patent protection in the future.
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