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.
Related Articles
- Leo Pharma is the new owner of Finacea
- Finacea User Reviews
- Finacea Available Over The Counter in Australia
- How would you like Metrogel and Finacea to be over the counter?
- Finacea (Azelaic Acid 15%) User Reviews
- Finacea Foam (azelaic acid 15%) User Reviews
- Metrogel, Finacea and Oracea are Best for Rosacea
“You will of course save the cost of visiting your doctor and avoiding the hassle of getting a prescription filled.”
Generic drugs don’t have to be prescribed by a doctor?
Yes, of course you are correct. I fixed the article to remove that claim. thanks.