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Glenmark Pharmaceuticals receives ANDA approval for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg: Granted competitive generic therapy (CGT) designation and is eligible for 180 days of CGT exclusivity

Mumbai, India, March 24, 2021: Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, the generic version of Thorazine^®1 Tablets, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, of GlaxoSmithKline.

Glenmark has been granted a competitive generic therapy (CGT) designation for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, therefore, with this approval, Glenmark is the first approved applicant for such competitive generic therapy and is eligible for 180 days of CGT exclusivity upon commercial marketing.

According to IQVIA^TM sales data for the 12 month period ending January 2021, the Thorazine^®1 Tablets, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg market² achieved annual sales of approximately $108.6 million*.

Glenmark’s current portfolio consists of 171 products authorized for distribution in the U.S. marketplace and 41 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

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About Glenmark Pharmaceuticals Ltd
Glenmark Pharmaceuticals Ltd. (GPL) is a global research‐led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries. Glenmark’s key therapy focus areas globally are respiratory, dermatology and oncology. It is ranked among the top 80 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2019). The company has been listed in the Dow Jones Sustainability Index (DJSI), under the category of emerging markets for the third consecutive year in a row. DJSI is one of the world’s most respected and widely accepted sustainability benchmarks globally with only the top ranked companies in terms of Corporate Sustainability within each industry are featured in the index.
For more information, visit www.glenmarkpharma.com

For more information:
Glenmark Media Contacts
Udaykumar Murthy
Senior Manager, Corporate Communications
+91 9960377617
corpcomm@glenmarkpharma.com

¹All brand names and trademarks are the property of their respective owners.
²Market includes brand and all available therapeutic equivalents
*IQVIA^TM National Sales Perspectives: Retail & Non‐Retail, January 2021

Glenmark Pharmaceuticals receives ANDA approval for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg: Granted competitive generic therapy (CGT) designation and is eligible for 180 days of CGT exclusivity

Mumbai, India, March 24, 2021: Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, the generic version of Thorazine^®1 Tablets, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, of GlaxoSmithKline.

Glenmark has been granted a competitive generic therapy (CGT) designation for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, therefore, with this approval, Glenmark is the first approved applicant for such competitive generic therapy and is eligible for 180 days of CGT exclusivity upon commercial marketing.

According to IQVIA^TM sales data for the 12 month period ending January 2021, the Thorazine^®1 Tablets, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg market² achieved annual sales of approximately $108.6 million*.

Glenmark’s current portfolio consists of 171 products authorized for distribution in the U.S. marketplace and 41 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

‐‐‐‐‐‐End‐‐‐‐‐‐

About Glenmark Pharmaceuticals Ltd
Glenmark Pharmaceuticals Ltd. (GPL) is a global research‐led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries. Glenmark’s key therapy focus areas globally are respiratory, dermatology and oncology. It is ranked among the top 80 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2019). The company has been listed in the Dow Jones Sustainability Index (DJSI), under the category of emerging markets for the third consecutive year in a row. DJSI is one of the world’s most respected and widely accepted sustainability benchmarks globally with only the top ranked companies in terms of Corporate Sustainability within each industry are featured in the index.
For more information, visit www.glenmarkpharma.com

For more information:
Glenmark Media Contacts
Udaykumar Murthy
Senior Manager, Corporate Communications
+91 9960377617
corpcomm@glenmarkpharma.com

¹All brand names and trademarks are the property of their respective owners.
²Market includes brand and all available therapeutic equivalents
*IQVIA^TM National Sales Perspectives: Retail & Non‐Retail, January 2021