9. Lupin

Pills
Lupin's acquisition of U.S.-based Gavis, completed in March 2016, helped boost its generic sales.

Lupin
Headquarters: Mumbai, India
2016 generic sales: $2.48 billion (estimate)

2016 was a mixed year for Lupin. It completed the acquisition of U.S.-based Gavis in March 2016, obtaining its first manufacturing site in the U.S., along with some 60 ANDA filings pending approval with the FDA at that time; but a Form 483 for its Goa plant and two large-scale drug recalls because of failed ingredients were setbacks.

For the entire fiscal year ending March 2017, Evaluate estimated that Lupin’s total generic revenue reached $2.48 billion. To put that into context, the company’s entire revenue—generic and branded—in the previous fiscal year was $2.09 billion. That volume boost was largely thanks to the Gavis purchase.

The two first struck the $880 million deal in July 2015. In what Lupin touted as the largest acquisition made by an Indian pharmaceutical company in the U.S., Lupin broadened its portfolio to more than 120 marketed products, nabbed a manufacturing and R&D site, a packaging and distribution facility and 62 ANDA filings with the FDA worth more than $9 billion.

Lupin said that upon completion of that buy, the company has the fifth-largest pipeline of ANDA filings with the U.S. FDA (the branded counterparts of those generics total a $63.8 billion market), plus 45 first-to-file products, including 25 exclusive ones.

It immediately tapped industry veteran Kurt Nielsen, Ph.D., to lead the new U.S. business called Lupin Somerset. He was formerly with Sandoz as global head of product development and VP of U.S. product development, portfolio and launch management.

For the fiscal year from April 2016 to March 2017, Lupin also launched 13 generic products in the U.S. Among them is a generic of Pfizer’s antidepressant Pristiq, which reeled in $578 million in U.S. sales for the Big Pharma in 2016. But Mylan, Actavis and Sandoz are also eying the same product.

Lupin also revealed in early 2016 that it is building a dedicated oral solids plant in Tottori, Japan, that would be able to produce 2 billion tablets a year. Japan represents the Indian drugmaker’s third-largest market, following the U.S. and India, and the country’s growing demand for generics is beyond the ability of its current facility in Sanda, Japan. It also indicated it was seeking out potential M&A targets in Japan.

But it was not all smooth sailing for Lupin. First, there were still no words about completion of the acquisition of Russian generic drugmaker ZAO Biocom. Lupin announced in July 2015 that it had a deal to buy 100% equity stake in the Russian company, but regulatory roadblocks have gotten in the way and it has yet confirm the deal has been completed.

Perhaps not as deep in the FDA regulatory quagmire as its fellow Indian drugmaker Sun Pharma, Lupin also has its own share of problems to worry about.

The FDA cited nine observations in a Form 483 sent to Lupin’s Goa, India, plant in March 2016. After clearing the concerns in November, the plant was cited again after an inspection this year.

9. Lupin