Will Humira Patent Expiration Incapacitate AbbVie’s Future Plans?

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The pharmaceutical company has no immediate threat to competition as majority of its Humira patents are valid till 2032

AbbVie Inc (NYSE:ABBV) is facing a major threat with its patent expiration of Humira in December 2016. Humira is the revenue generator for the company and AbbVie is working on all possible options in order to extend the patent expiration date and label expansion of the molecule. 

Besides, the patent expiration threat, AbbVie has opportunity to aggressively market the remaining 75% of the patent in multiple therapeutic markets, which are expected to expire in 2032. This will be giving the company a time window to look for another blockbuster molecule like Humira. The molecule has generated $14.01 billion in 2015, keeping its dominance on the lucrative market of inflammatory diseases. 

The competition between the drugs indicated for the management of inflammatory disease is increasing day-by-day with the launching of the generics as well as biosimilars. Humira was approved by the Food and Drug Administration (FDA) in 2013 for the treatment of multiple ailments in relation to the auto-immune diseases such as Crohn’s disease and rheumatoid arthritis. Despite the fierce competition and launching of the biosimilars, the drug is expected to generate $18 billion by 2020.

The launch of the biosimilars will increase pricing pressure on AbbVie’s Humira as biosimilars are cost effective and provide the same efficacy and safety profile. On the other hand, the Pharmacy Benefit Managers are emphasizing on the cheap drugs as well as generics in order to provide relief to the insurers. 

With the approval of Amgen’s biosimilar of Humira, AbbVie faced a shock and stock price suffered massively. Despite that, other pharmaceutical companies such as Eli Lilly, Pfizer and Gilead Science are working to make their position strong in the inflammatory diseases therapeutic area.  The company has missed its earnings in third quarter financial year (3QFY16) with the main reason of Humira revenue decline. The company has to work on options in order to patch up the revenue, as in the near future the competition will get fierce. 

Pfizer and Eli Lilly/Incyte and Gilead are working on JAK category of drugs, which showed comprehensive results in the management and treatment of rheumatoid arthritis. The aforementioned molecules are proving their efficacy and, according to analysts, will be blockbusters within five years’ time.

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