Natco rolls out Baricitinib ahead of approval for patent waiver | Hyderabad News – Times of India

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HYDERABAD: Even as it has filed for a compulsory licence for Covid-19 drug Baricitinib in India, Natco Pharma has already begun rolling out its generic version of the rheumatoid arthritis drug under the Barinat brand.
Natco launched its 4mg tablets at Rs 30 a piece on Thursday and stocks of the drug are already in the market, sources with know of the matter told TOI.
The 4mg dosage tablet accounts for nearly 95% of the market for this drug for SARS-CoV-2 treatment, they added. Barinat is priced at less than 1% or nearly one-hundredth the price of the innovator drug Olumiant, which is pegged at around Rs 3,230 per tablet.
According to analysts, by going ahead with a drug rollout without waiting for the CL, Natco runs the risk of being sued for infringement by the patent holder. While the patent for Olumiant is held by Incyte Holdings, the drug is marketed by giant Eli Lilly.
But Eli Lilly, which also got restricted emergency use approval for Baricitinib 2mg and 4mg from the Central Drugs Standard Control Organisation (CDSCO) on Monday, said that it is “working with local Indian pharma companies to execute royalty-free voluntary licensing agreements to accelerate manufacturing and distribution of the medicine in India during the pandemic”.
In a press communique issued earlier this week, Lilly also said it will be donating Baricitinib tablets to the Indian government, including an immediate initial donation of 4 lakh tablets for eligible hospitalised Covid-19 patients. The Barinat 1mg and 2mg tablets, to be priced at Rs 15 and Rs 20 a piece, respectively, will be rolled out shortly, sources added.
The Barinat launch comes less than a week after Natco received emergency use approval from the CDSCO for the Covid-19 drug. Baricitinib, approved by USFDA for use with Remdesivir in November 2020, prevents a cytokine storm that Covid-19 triggers.
In its CL application, filed under Section 92 of the Patents Act, Natco had cited unmet medical needs due to lack of supply and affordability in light of the grave and life-threatening national public health emergency as the main grounds for seeking the CL.
Natco’s application said Olumiant is not manufactured in India and less than 9,000 tablets were imported in 2019 and 2020, which were enough to meet the needs of only around 600 patients.



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