Natco Launches Baricitinib Ahead of Patent Waiver Approval | Hyderabad News


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HYDERABAD: Even as it filed for a compulsory license for the Covid-19 drug Baricitinib in India, Natco Pharma has already started rolling out its generic version of the rheumatoid arthritis drug under the Barinat brand.
Natco launched its 4 mg tablets at Rs 30 a unit on Thursday and stocks of the drug are already on the market, knowledgeable sources told TOI.
The 4 mg tablet represents almost 95% of the market for this drug for the treatment of SARS-CoV-2, they added. The price of Barinat is less than 1%, or nearly one hundredth of the price of the innovative drug Olumiant, which is set at around Rs 3,230 per tablet.
According to analysts, by continuing to roll out a drug without waiting for CL, Natco runs the risk of being sued for infringement by the patentee. While the patent for Olumiant is held by Incyte Holdings, the drug is marketed by giant Eli Lilly.
But Eli Lilly, who also obtained approval on Monday for restricted emergency use of baricitinib 2 mg and 4 mg from the Central Drugs Standard Control Organization (CDSCO), said he was “working with local Indian pharmaceutical companies. to execute royalty-free voluntary license agreements to speed up. manufacture and distribution of the drug in India during the pandemic ”.
In a press release released earlier this week, Lilly also said she would donate baricitinib tablets to the Indian government, including an immediate initial donation of 4 lakh tablets for eligible Covid-19 hospital patients. Barinat 1 mg and 2 mg tablets, which are priced at 15 and 20 rupees respectively, will be launched soon, sources added.
The launch of Barinat comes less than a week after Natco received emergency use approval from CDSCO for the drug Covid-19. Baricitinib, approved by the USFDA for use with Remdesivir in November 2020, prevents a cytokine storm triggered by Covid-19.
In its CL application, filed under Section 92 of the Patent Act, Natco cited unmet medical needs due to lack of supply and affordability in light of the national emergency of serious and potentially fatal public health as the main reasons for requesting LC.
Natco’s app says Olumiant is not made in India and less than 9,000 tablets were imported in 2019 and 2020, which was enough to meet the needs of just around 600 patients.
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