FDA Approves First Generic Versions of Amgen’s Sensipar

Posted 08 March 2018 | By Zachary Brennan 

FDA Approves First Generic Versions of Amgen’s Sensipar

The US Food and Drug Administration (FDA) on Thursday approved the first generic versions of Amgen’s Sensipar (cinacalcet hydrochloride) for the treatment of a thyroid issue for certain patients on dialysis.

The approvals for Cipla Limited and Aurobindo Pharma provide for the first generic competition for Sensipar, which brought in $1.72B in 2017 sales, or 7.5% of Amgen revenue.

On 21 February, the District of Columbia’s District Court denied Amgen a six-month extension of market exclusivity for Sensipar.

When the Sensipar generics will launch on the US market remains unknown. Bernstein biotech analyst Ronny Gal noted that Amgen last week settled litigation with Mylan and Cipla -- the other two companies with tentative approvals for Sensipar generics.

These two approvals were the 9th and 10th first generic approvals of 2018.

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