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Sun Pharma launches Gleevec's generic in US

The company, which received final approval for imatinib mesylate from US FDA in December 2015, also has 180 days of marketing exclusivity for being a first-to-file product

Sun Pharma launches Gleevec’s generic in US

BS B2B Bureau Mumbai
Sun Pharma has launched imatinib mesylate tablet, the generic version of Novartis’ Gleevac, in US market. Sun Pharma’s subsidiary had received final approval for imatinib mesylate from US FDA in December 2015. Being a First-to-File product, it was granted 180 days of marketing exclusivity by FDA from the time of its launch.
 
As part of this launch, in addition to strengthening distribution in the US, the company has rolled-out unique Sun Pharma Imatinib Mesylate Savings Card program. This program aims to deliver greater access to the drug for patients who have a commercial insurance but their out-of-pocket may exceed an affordable amount.
   
“The savings card will reduce patient’s co-payment (out-of-pocket) to $10. In line with its philosophy of putting patients first, Sun Pharma’s Imatinib Mesylate Savings Card will also offer patients additional savings benefit of up to $ 700 for a 30-day fill to offset any additional out-of-pocket cost should they be required to meet their deductible or co-insurance. Participating pharmacies across USA can use the patient’s Sun Pharma’s Imatinib Mesylate Savings Card as part of this program,” said Sun Pharma in a press release.
 
As per IMS MAT August 2015, imatinib mesylate tablets (100 mg and 400 mg) have annual sales of approximately $ 2.5 billion in the US. These tablets are indicated for the treatment of chronic myeloid leukemia.
 
Sun Pharma has established a hub service where patients can dial-in to speak with a trained healthcare professional and discuss imatinib mesylate when used for indications approved by FDA under Sun Pharma’s ANDA.

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First Published: Feb 01 2016 | 9:43 PM IST

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