The launch of the generic versions of dasatinib, following the expiration of Indian patent in April 2020 will increase the accessibility for treatment of chronic myeloid leukemia (CML)  and acute lymphoblastic leukemia (ALL) and subsequently result in huge cost savings, says GlobalData, a leading data and analytics company.

Post patent expiry of BMS’ Sprycel (dasatinib), Dr. Reddy’s has launched the first branded generic for dasatinib under the brand name ‘Invista’ on 13 April 2020 in 50mg, 70mg and 100mg dose strengths. Shilpa Medicare is the first company to have launched dasatinib generic Dasashil in all strengths of 20mg, 50mg, 70mg and 100mg as branded drug.

According to GlobalData’s Pharma Intelligence Center, the incidence of CML and ALL will be 0.65 and 0.38 cases, respectively, per 100,000 population by 2022 in India.

Bhavani Nelavelly, Pharma Analyst at GlobalData, says: “The patent protection period of expensive cancer drugs like dasatinib poses a great challenge for access and represents a monopoly. The second generation tyrosine kinase inhibitors (TKIs) are considered to be poor treatment options for frontline CML treatment because of their current exorbitant prices. The launch of dasatinib generics in India will significantly improve the access for this drug, which was earlier limited by cost.”

CML is the most common leukemia in adults in India. The median age of patients in India is 10-years younger than western countries. Although imatinib (first generation TKI inhibitor) generics are available in India from January 2016, patients had a poorer response as Indian patients present with more advanced disease at the time of diagnosis, and majority of the patients who experienced treatment failure with imatinib went back for treatment with hydroxyurea because of exorbitant price of dasatinib.

Natco had launched the generic version of dasatinib in 2012 but failed in court as the court uphold the BMS patent. Similary BDR pharmaceuticals, Cipla have lost the court verdict against BMS in 2015, which sought a compulsory licence to sell generic dasatinib in local market.

Nelavelly concludes: “If majority of the newly diagnosed patients are put on dasatinib generics, and it is found to be effective, they can continue the medicine for rest of their lives, which amounts to a huge cost savings for both patients and insurers. Following the patent expiry of Sprycel, the cost of dasatinib per month for a patient will likely to see a huge drop of 96.1% to US$85 (INR 6,440) from the branded drug cost of US$2,184 (INR1,65,000) per month, which will increase the penetration rate of dasatinib due to its affordability.

“Cancer drugs are increasingly patented with limited generic competition, putting them out of the reach of poor patients. With Sprycel going off-patent now, the prices will be set to a true cost of the drug, and there can be more generics expected to be launched in next few years, like we have seen with Gleevec.”