Three FDA approvals for Glenmark as it enters US branded dermatology market

Biosimilares/Novedades | Posted 22/02/2019 post-comment0 Post your comment

Glenmark Pharmaceuticals Inc has been granted approval by the US Food and Drug Administration (FDA) for its generic versions of Zytiga, DermOtic oil and Qudexy XR, and has announced its entry into the US branded dermatology segment.


Glenmark has been granted tentative FDA approval for its abbreviated new drug application (ANDA) for abiraterone acetate tablets, 250 mg, a generic version of Zytiga tablets for the treatment of prostate cancer. It has also received tentative FDA approval for topiramate extended-release capsules, 25 mg, 50 mg, 100 mg, 150 mg and 200 mg (Qudexy XR extended-release capsules) for the treatment of seizures, as well as final approval for fluocinolone acetonide oil, 0.01% (DermOtic oil) for the treatment of eczema of the ear. Glenmark’s portfolio now consists of 148 products authorized for distribution in the US, and 54 ANDA’s pending FDA approval.

According to IQVIA sales data for the 12-month period ending November 2018, Zytiga tablets had annual sales of approximately US$1.3 billion and Qudexy XR extended release capsules had sales of approximately US$84.0 million. IQVIATM data for the 12-month period ending October 2018 showed that DermOtic oil achieved annual sales of approximately US$18.1 million.

On 19 December 2018, Glenmark announced that it would be entering the US branded dermatology market. Its portfolio will be developed and commercialized by Glenmark Therapeutics Inc USA, a wholly owned subsidiary of Glenmark Holding, SA. This represents a significant step in Glenmark’s long-term strategy to build a robust branded business in the US alongside its generics business.

Glenn Saldanha, Chairman and Managing Director of Glenmark says ‘Glenmark Pharmaceuticals has been committed to the area of dermatology globally for more than two decades. With our significant presence in the generic dermatology market in the US, this acquisition will give us a leading edge as we enter into a new segment of branded products. It will also serve as the foundation for commercialization of future branded assets in the US’.

To establish itself in the branded dermatology segment, Glenmark recently acquired the rights to seven branded dermatology products from Exeltis USA, Inc, which have cumulative sales of US$9 million. These products include Recedo topical gel, a leading prescription treatment for scar management and econazole nitrate topical foam, 1% (Ecoza), an antifungal medicine used to treat athlete’s foot and interdigital tinea pedis. Since all the acquired products are already approved and marketed in the US, Glenmark has immediate entry into the branded dermatology segment. Glenmark intends to launch further branded dermatology products over the next year, increasing its presence in the segment.

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