Competition heating up, with the US Food and Drug Association approving rival drugs, which could eat away at Cipla's market share in the generic business.
Cipla, which had a late start in tapping the US market, expects to garner around 25% of its total revenues from the US over the next four to five years. The company is said to be eyeing its first commercial launch in the US around 2020.
India's third largest drug maker Cipla recently closed the acquisitions of InvaGen and Exelan, the two companies it purchased last September in an all-cash transaction worth US$550m. The development marks an important step for the company in bolstering its fledgling presence in the US, with an additional revenue of $230m in 2017.
The company is planning to deploy more funds for research and development in respiratory, dermatology, neurology and oncology. It is also planning a pipeline of speciality drugs in the US.
Competition also seems to be heating up for Cipla, with the US Food and Drug Association approving drugs of its rivals, which could eat away at Cipla's market share in the generic business. The US FDA has accepted Hikma Pharmaceutical’s filing for a generic version of GlaxoSmithKline's Advair Diskus, an inhaler used for the treatment of asthma.
Cipla had planned to file an Abbreviated New Drug Application (ANDA) for the drug in 2016-17. Mylan has also filed an ANDA for the drug, which is still pending, while other companies like Teva and Sandoz have completed trials for the generic drug in the US.