SEBI Reg. Investment Advisor

Download App

MoneyWorks4Me

Sun Pharma’s arm gets US FDA’s nod for generic Gleevec

04 Dec 2015 Evaluate

Sun Pharmaceutical Industries’ subsidiary has received final approval from US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for generic version of Gleevec, Imatinib Mesylate tablets 100mg and 400mg.

Imatinib Mesylate tablets, 100 mg and 400 mg are therapeutic equivalents of Novartis’ Gleevec tablets. As per IMS MAT August 2015, these tablets have annual sales of around $2.5 billion in the US. These tablets are indicated for the treatment of chronic myeloid leukemia.

The Sun Pharma subsidiary, being the first-to-file an ANDA for generic Gleevec with a para IV certification, is eligible for 180-days marketing exclusivity in the US. Under the terms of a settlement agreement with Novartis, the Sun Pharma subsidiary is permitted to launch its version of generic Gleevec in the United States on February 1, 2016. The commercial launch of this product is scheduled for February 1, 2016.

Sun Pharma is the fifth largest specialty generic pharmaceutical company in the world. The company provides high quality, affordable medicines trusted by healthcare professionals and patients in over 150 countries worldwide.

Sun Pharma. Inds. Share Price

1909.95 5.30 (0.28%)
06-Jul-2026 09:09 View Price Chart
Peers
Company Name CMP
Sun Pharma. Inds. 1909.95
Dr. Reddys Labs. 1367.75
Cipla 1458.45
Zydus Lifesciences 1142.60
Lupin 2482.40
View more..

About MoneyWorks4Me

MoneyWorks4Me is a SEBI-registered Investment Adviser (IA) dedicated to helping investors build long-term wealth through transparent, research-driven, conflict-free guidance. Founded in 2008, we started our journey as a Research Analyst (RA), providing deep fundamental analysis, intrinsic value insights, and long-term investing frameworks for Indian equities. In 2017, we transitioned to a full-fledged SEBI-registered Investment Adviser, strengthening our commitment to acting as a fiduciary—always putting the investor’s interest first.

Our Vision

To become India’s most trusted, research-powered fiduciary advisory platform—where every investor, regardless of experience, can make calm, confident, and well-reasoned investment decisions.

What Makes MoneyWorks4Me Different

Our Approach: Ensuring compounding work its magic on client portfolio.

MoneyWorks4Me ensures this through: