Bajaj Healthcare seeks compulsory licence for Covid-19 drug Baricitinib

Eli Lilly has granted voluntary license to 6 Indian drugmakers for Baricitinib

Drugmaker Bajaj Healthcare (BHL) has requested the Indian patent office to grant a compulsory licence to make Baricitinib, an Eli Lilly drug which has shown promise in treating Covid-19.

Currently, Eli Lilly and company has received Emergency Use Authorization (EUA) from US Food and Drug Administration (FDA) for the distribution and emergency use of Baricitinib to be used in combination with remdesivir in hospitalised adult and pediatric patients aged more than two years with suspected or laboratory confirmed Covid-19 requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

EUA permits the emergency use of Baricitinib, in combination with remdesivir, for treatment of suspected or laboratory confirmed Covid-19 in hospitalized adults and paediatric patients above two years of age requiring supplemental oxygen, invasive mechanical ventilation, or ECMO.

BHL, which makes Covid drugs like favipiravir and ivermectin, has sought permission to make both the active pharmaceutical ingredient (API) and the formulation of Baricitinib.

BHL approached Eli Lilly & Company on two occasions, to sign the voluntary license for manufacturing and supply of Covid-19 drug Baricitinib.

“BHL assured them, about manufacturing high-quality product at an affordable price for the Indian patient population. Eli Lilly & Company declined the applications on both the occasion, citing the reason that it is really challenging for them to sign voluntary licensing agreements with all the Indian companies who have requested for the same,” the company said in a statement.

It added: “When all the attempts to get the voluntary license from the Patentee were futile, BHL moved to Indian Patent Office, requesting to grant compulsory licence for manufacture and supply of Covid-19 drug Baricitinib, so that it can supply the essential medicine in this pandemic situation in India.”

Anil Jain, Joint Managing Director, Bajaj Healthcare Limited said “We have moved the Indian Patent Office to grant compulsory license for manufacturing & supply of Covid Drug Baricitinib (API and formulation). Currently the drug Baricitinib is licensed to US pharma giant Eli Lilly & Company, by its originator company INCYTE, providing them the rights for marketing it across the globe. Considering our manufacturing capabilities & strong in-house R&D team, we can produce Baricitinib at very competitive and affordable prices in India.”

A compulsory license implies not requiring permission from the owner of the patented drug. In contrast, Voluntary licence involves the permission given by the patent holder to manufacture and sell the drug.

According to reports, BHL claims that it can make the drug as cheap as Rs 14 for 1 mg strength, Rs 18 (2 mg) and Rs 28 (4 mg) tablets. The company has said that the average cost of Baricitinib is Rs 3230 per tablet and the total course would cost Rs 45,220 per patient.

Earlier, Indian drug major Natco planned to seek compulsory licence for the same drug. Hyderabad based Natco had received an EUA from India’s drug regulator too in May. Eli Lilly granted a voluntary license to Natco along with six other Indian drugmakers, including Sun Pharma, Lupin, Cipla, and Torrent.