Mumbai, Baltimore: Pharma major Lupin Limited (Lupin) announced the launch of Imatinib Mesylate Tablets, 100 mg (base) and 400mg (base).Lupin’s alliance partner Natco had received an approval from the United States Food and Drug Administration (U.S. FDA) earlier.

Lupin’s Imatinib Mesylate Tablets, 100mg (base) and 400mg (base), is the generic version of Novartis PharmaceuticalsCorporation’s (Novartis) Gleevec® Tablets, 100mg and 400mg. It is indicated for the treatment of:

• Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
• Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy.
• Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
• Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements as determined with an FDA-approved test.
• Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation as determined with an FDA-approved test or with c-Kit mutational status unknown.
• Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown.
• Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).

Imatinib Mesylate Tablets, 100mg (base) and 400mg (base), had annual sales of approximately USD 548 million in the US (IQVIA MAT May 2019).

About Lupin Limited

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded and generic formulations, biosimilar products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.

Lupin is the 8th largest generics pharmaceutical company by revenues (31st Dec 2018, Bloomberg LTM). The Company is the 3rd largest pharmaceutical player in the US by prescriptions (IQVIA MAT Mar 2019); 3rd largest Indian pharmaceutical company by global revenues (31st Dec 2018, Bloomberg LTM); 5th largest company in the Indian Pharmaceutical Market and 6th largest generic pharmaceutical player in Japan (IQVIA MAT Mar 2019).

For the financial year ended 31st March 2019, Lupin’s Consolidated sales and Net profits before exceptional items were at INR 163,694 million (USD 2.34 billion) and INR 9,466 million (USD 136 million) respectively. Please visit http://www.lupin.comfor more information. You could also follow us on Twitter at – www.twitter.com/lupinglobal

CIN: L24100MH1983PLC029442 Registered Office: Lupin Ltd, 3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz (East), Mumbai 400 055.

For further information or queries please contact –

Pooja Thakran
VP – Corporate Communications
Ph: +91-22 6640 2531 / 9811665000
Email: poojathakran@lupin.com

Or

Arvind Bothra
Head – Investor Relations
Ph: +91-22 6640 8237
Email: arvindbothra@lupin.com

*Safe Harbor Statement

Gleevec ^® is a registered trademark of Novartis AG Corporation Switzerland.