Compulsory licensing: A nightmare awaiting pharma MNCs?

Hyderabad-based Lee Pharma, a manufacturer of intermediates and APIs, has taken the global pharma world by storm after aggressively filing its application requesting for the grant of compulsory licensing for the manufacture of Saxagliptin in India.


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Saxagliptin (Onglyza) is a drug used in treating type-2 diabetes. Initially, the molecule was discovered and developed by Bristol-Myers Squibb (BMS) and was later, in 2007, joined by AstraZeneca (AZ) to further develop and commercialize the product.

Saxagliptin's history

Between the co-developmental period 2007 through 2009, AZ solely bore the developmental costs, post which both the companies shared their spending for other additional costs incurred.

In the beginning of 2014, AZ acquired the entire BMS' diabetes business through a staggering $4 billion transaction.

The acquisition gave AZ complete ownership of all the intellectual properties (IP) and global rights for developing, manufacturing and commercializing BMS' diabetes drugs, which included Saxagliptin among others.


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