‘Patent expiry of blockbuster drugs has opened significant growth opportunities for Indian API Market’ says RNCOS.

A large number of major blockbuster drugs have lost their patent, and various others are tending towards patent expiration in the coming years. The patent expiry of blockbuster drugs will provide numerous opportunities for the growth of generic drugs and in turn generic API market. Looking at the current scenario, numerous players in pharmaceutical industry are developing generic and biosimilar drugs in order to grow in the global market. According to report published by RNCOS, named, “Indian API Market Outlook 2022”, for the development of low cost generic and biosimilar drugs, the companies need low cost and high quality APIs which is readily available in India.

Key biologic drugs like Amgen’s Enbrel (US$ 5.36 Billion in 2015), J&J’s Remicade (US$ 5.9 Billion), Genentech’s Rituxan (US$ 5.7 Billion), BMS/Merck’s Erbitux (US$ 1.6 Billion), Abbott & Eisai’s Humira (US$ 5.5 Billion), and two of Genentech’s brands: Herceptin (US$ 4.9 Billion) and Avastin (US$ 5.8 Billion) are some of the biologics that will lose patent protection in the coming years. According to Generics and Biosimilars Initiative (GaBI), biologics worth more than US$ 67 Billion will lose their patent before 2020.

Moreover, Pharmexcil estimated that around US$ 40 Billion worth of drugs in the US and US$ 25 Billion worth of drugs in Europe will be going off patent (series of patent expirations of important prescription drugs) in the coming years. Patent expiry of Lipitor by Pfizer, Diovan by Novartis, Plavix by Bristol-Myers Squibb etc. have already pushed Indian generic players to expand in international markets.

Subsequently, some of the other global pharma majors such as Teva, GlaxoSmithKline, and Allergen are likely to lose patent exclusivity of several drugs. This patent cliff will thus provide significant opportunity to Indian manufacturers to develop generic versions of respective patented drugs for which they will be making use of generic APIs. The patent expiry of drugs will give impetus to the development of the API industry in India.

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