Lupin unveils generic Imatinib Mesylate tablets to treat types of cancer

Lupin's Imatinib Mesylate Tablets, 100mg (base) and 400mg (base), is the generic version of Novartis Pharmaceuticals Corporation's (Novartis) Gleevec Tablets, 100mg and 400mg in the same strength, the company said.

Mumbai: Pharma major Lupin Limited (Lupin) recently announced the launch of Imatinib Mesylate Tablets, 100 mg (base) and 400mg (base) indicated for the treatment of types of cancer. Lupin's alliance partner Natco had received approval from the United States Food and Drug Administration (USFDA) earlier.

Lupin's Imatinib Mesylate Tablets, 100mg (base) and 400mg (base), is the generic version of Novartis Pharmaceuticals Corporation's (Novartis) Gleevec Tablets, 100mg and 400mg in the same strength, the company said.

Also Read: Lupin gets USFDA nod for generic versions of Sensipar tablets, Omidria intraocular solution

The product is used to treat various types of cancer including;

• 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 the 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).

As per IQVIA MAT May 2019 data, Imatinib Mesylate tablets, 100 mg (base) and 400 mg (base) had annual sales of around USD 548 million in the US market, Lupin added.

Headquartered in Mumbai, Lupin develops and delivers 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 a global leadership position in the Anti-TB segment.

Read Also:Lupin gets tentative USFDA nod for generic version of Mirabegron ER tablets