15. Cipla

2014 Generics Sales: $1.4 billion +17%
Worldwide Market Share: 1.9%

India's Cipla grew its 2014 generics sales 17% to $1.4 billion, and it has done so aggressively. But what distinguishes Cipla from other Indian generics companies is its geographic focus. Rather than targeting the U.S. market, it has concentrated on India, challenging the patents on Big Pharma's top drugs. And its generics revenue reflects that: 42% of its revenue came from India, while 8% came from the U.S.

The company has also put together partnerships and operations in many developing countries, like Iran and Yemen, where other drugmakers are leery of entering. For example, in July 2014, Cipla expanded in Yemen, where it was already selling 200 products. It agreed to buy a 51% stake in a pharmaceuticals manufacturing and distribution business there for $21 million. And in a cagey October statement, Cipla said it was tapping "its existing Iranian distributor for setting up a manufacturing facility in Iran," without giving further details.

In September, Cipla bought two manufacturing facilities in India from Okasa for $16.7 million, and earlier in the year it reported it would spend $14 million to acquire a 60% stake in a Sri Lankan company that would distribute its products there. The company has successfully incorporated its subsidiaries in Sri Lanka and Morocco, and integrated its front-end teams in Myanmar, Nepal and Malaysia, among other markets.

As for the U.K., Cipla announced in July that it would invest $172 million to beef up sales of its respiratory, oncology and antiretroviral drugs there.

In 2014, it launched sofosbuvir--generic Sovaldi--in India, where it has about 5% of the generics market share. But the real star of the show is its flagship product: fluticasone-salmeterol MDI, or generic Advair. The GlaxoSmithKline ($GSK) blockbuster went off patent in the U.S. in 2009 and in Europe in 2013. Cipla's Advair copy was rolled out in Germany and Sweden in September 2014. By then, it was already being sold in Croatia and approved in 10 countries. Its licensing agreement for sofosbuvir allows Cipla to market it in 91 countries.

Cipla made 12 new regulatory filings in North America in 2014 and launched several new products in that market, including amlodipine, doxycycline, meloxicam and valacyclovir.

Cipla is known for its willingness to tangle with Western drug companies in India over patents and prices, and that sometimes means court battles. Cipla petitioned the Indian government to revoke 5 patents for Novartis' ($NVS) COPD drug Indacterol but rolled out a copy without waiting for a decision. It claimed there was a public healthcare need and not enough local access. It priced its version at about a fifth of the cost of Indacterol. But Novartis didn't see it that way and sued Cipla in December.

Cipla is waging other patent battles in India, most notably with Roche ($RHHBY) over a lung cancer drug. A court ruled in 2012 that Cipla's knockoff didn't infringe Roche's patent, but thanks to a Roche appeal, the case is still floating around the courts.

More recently, Cipla has been convinced to do more in the U.S. This year it agreed to pay $550 million for New Jersey-based InvaGen and a marketing subsidiary, getting a small portfolio of drugs and its first U.S. manufacturing facility.

-- Amirah Al Idrus (email | Twitter)

For more:
India's Cipla gets U.S. beachhead with $550M deal for 2 generics operations
Novartis sues Cipla for ignoring its COPD drug patents
Cipla petitions India to revoke Novartis respiratory drug patents, launches low-cost version of drug
Cipla works with partner to build a manufacturing plant in Iran
Mylan, Ranbaxy, others to bring cheap Sovaldi to 91 markets
Cipla buys two Indian manufacturing facilities from partner Okasa

15. Cipla
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