Glenmark Pharmaceuticals ltd — Regulatory Filings 2018

Nov 16, 2018

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November 16, 2018

To, Dy. General Manager Department of Corporate Services, BSE Ltd., P. J. Towers, Dalal Street, Fort, Mumbai – 400 001

To, The Manager – Listing, The National Stock Exchange of India Ltd., Plot No. C/1, G Block, Bandra Kurla Complex, Bandra (E), Mumbai – 400 051

Ref: Scrip Code: 532296

Ref: Scrip Name: GLENMARK

Dear Sirs,

Sub: Glenmark Pharmaceuticals receives ANDA approval for Teriflunomide Tablets, 7 mg and 14 mg

With reference to the subject mentioned above, kindly find attached media release which is selfexplanatory.

Request you to kindly take the same on record.

Thanking you,

Yours faithfully,

For Glenmark Pharmaceuticals Limited

HARISH Digitally signed by VINAYAK HARISH VINAYAK KUBER Date: 2018.11.16 KUBER 08:58:09 +05'30' Harish Kuber Company Secretary & Compliance Officer

Encl: as above

Glenmark Pharmaceuticals Ltd. Glenmark House, B D Sawant Marg, Andheri (E), Mumbai 400 099 T: 91 22 4018 9999 F: 91 22 4018 9988 CIN No: L24299MH1977PLC019982 W: www.glenmarkpharma.com Registered office: B/2, Mahalaxmi Chambers, 22 Bhulabhai Desai Road, Mumbai 400 026 E: complianceofficer@glenmarkpharma.com

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Press Release

For Immediate Release

Glenmark Pharmaceuticals receives ANDA approval for Teriflunomide Tablets, 7 mg and 14 mg

Mumbai, India, November 16, 2018: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Teriflunomide Tablets, 7 mg and 14 mg, a generic version of Aubagio®[1] Tablets, 7 mg and 14 mg, of Sanofi-Aventis U.S., LLC.

With respect to 180-day generic drug exclusivity, we note that Glenmark was one of the first ANDA applicants to submit a substantially complete ANDA for Teriflunomide Tablets, 7 mg and 14 mg, with a paragraph IV certification. Therefore, with this approval, Glenmark is eligible for 180 days of shared generic drug exclusivity for Teriflunomide Tablets, 7 mg and 14 mg.

According to IQVIA[TM ] sales data for the 12 month period ending September 2018, the Aubagio® Tablets, 7 mg and 14 mg market[2] achieved annual sales of approximately $1.6 billion*.

Glenmark’s current portfolio consists of 142 products authorized for distribution in the U.S. marketplace and 57 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.

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, September 2018

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About Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical organization. It is ranked among the top 75 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2018). Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). Glenmark has several molecules in various stages of clinical development and is focused in the areas of oncology, dermatology and respiratory.

The company has a significant presence in the branded generics markets across emerging economies including India. Glenmark has 16 manufacturing facilities across five countries and has six R&D centers. The Generics business of Glenmark services the requirements of the US and Western European markets. The API business sells its products in over 80 countries, including the US, various countries in the EU, South America and India.

For further information, please contact:

Isha Trivedi Glenmark, Mumbai, India Tel: +91 22 4018 9801 Email: corpcomm@glenmarkpharma.com

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