News today that Glenmark Pharmaceutiacals has received approval from the FDA to manufacture a generic form of Azelaic Acid Gel 15% (marketed under the name Finacea).

There has been quite a bit of business activity related to Finacea in the last year. Indeed back in 2013 we learnt that Bayer HealthCare the makers of Finacea, was suing Glenmark Pharmaceuticals to stop is producing generic Finacea before the patents  were due to expire in 2018. In August this year Finacea was sold to Leo Pharma. Bayer has retained the rights to the related product Finacea Foam.

Well now the patents have expired for Finacea Gel, paving the way for Glenmark to market their own generic version of azelaic acid gel 15%.

Note that Finacea has been available in Australia without prescription for several years now.

The press release also tells us that for the year ending September 2018, Finacea was responsible for $USD 64 million in sales.

No guarantee of price drop

Note that even though a generic version of Finacea will likely soon become available, there is no inherent guarantee that Glenmark will sell their generic version significantly cheaper.

In the end Glenmark will charge the maximum amount that it considers that the market can bear.

Press Release

Glenmark Pharmaceuticals receives ANDA approval for Azelaic Acid Gel, 15% [pdf]

Mumbai,  India, November  20,  2018

Glenmark  Pharmaceuticals  Inc.,  USA  (Glenmark)  has  been  granted final approval  by  the  United  States  Food  &  Drug  Administration  (U.S.  FDA)  for Azelaic  Acid  Gel,  15%, a generic version of Finacea 1Gel, 15%, of Leo Pharma A/S.

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