Having registered a decline in its revenue and profits on account of lower sales in domestic oncology and weak realization of profits from Oseltamivir product in the US market, the first four months for NATCO Pharma Limited have been highly fruitful for 2021. 

The company has managed to get approvals for four of its products, two each for pharmaceuticals and agrochemicals. Apart from this, NATCO’s first launch in 2021 was Brivaracetam tablets for treatment of Epilepsy, the company launched it under brand BRECITA in India and will be available in two strengths of 50 mg and 100 mg at significantly lower MRP prices of Rs. 25 and Rs. 35 per tablet respectively. Originally developed by UCB Pharma, Brivaracetam is currently marketed in India by Dr. Reddy’s under the brand name Briviact. 

On March 08, 2021, NATCO Pharma’s marketing partner, Breckenridge Pharmaceutical received final approval for its Abbreviated New Drug Application (ANDA) for Everolimus tablets (generic for Afinitor) for the treatment of breast cancer and a few other types of cancers from the U.S. Food and Drug Administration (USFDA). It plans to launch 2.5 mg, 5 mg, and 7.5 mg strengths of the product shortly within the next few weeks. The company will announce the launch date of 10 mg strength of the product at a later date. As per industry sales data, Afinitor and its therapeutic equivalents had generated annual sales of US $712 million in the USA during the twelve months ending December 2020. 

Again on April 12, 2021, NATCO through its marketing and distribution partner Alvogen Pine Brook LLC, received tentative approval for its Abbreviated New Drug Application (ANDA) for Ibrutinib tablets 560 mg, 420 mg, 280 m,g and 140 mg strengths (generic for IMBRUVICA), from the USFDA. Based on its ANDA filing date and the approval timeline, NATCO is eligible for 180 days of sole generic marketing exclusivity for all the strengths of the tablet dosage form of the product at the time of launch. As per industry sales data, IMBRUVICA had generated annual sales of US $3.7 billion during the twelve months period ending December 2020 in the US market. 

NATCO has recorded consolidated total revenue of Rs. 386 crore for the third quarter ended on 31st December 2020, as against Rs. 513 crore for the same period last year. While the company is yet to declare the overall results for FY 2020-21, the new product launches are expected to make up for the loss in the upcoming fiscal year.

Bets big on agrochemical

NATCO will soon be the first indigenous manufacturer of Chlorantraniliprole (CTPR) Technical 93.00% w/w min. under Section 9(3) of Insecticides Act, 1968. On February 5, 2021, the company received its registration approval for this technical product from the Central Insecticide Board & Registration Committee. CTPR technical is formulated into broad-spectrum insecticides used in several crops for better pest management. NATCO hopes to bring products based on CTPR shortly that would be affordable and accessible to farmers across India. 

CTPR is an active ingredient used in products commercialized by FMC under brands Coragen and Ferterra. The sales generated from CTPR containing products in India, inclusive of third-party marketing companies, as per declaration given by FMC was estimated to be Rs. 1,540 crores in 2016. NATCO believes the current market size to be over Rs. 2,000 crores. NATCO has pending litigation against FMC for declaration of freedom to use CTPR. 

The company on March 15, 2021, made its foray into Pheromone-based mating disruption technology for Integrated Pest Management (IPM) solution to farmers in India. NATCO through its Crop Health Science (CHS) division is working with ATGC Biotech for the technology. 

During Kharif 2021, NATCO plans to launch its first Green Label Pheromone product for Effective Management of Pink Bollworm (PBW) in cotton crop, under its brand NATMATE PBW. This is the first Pheromone-based indigenously manufactured product that received approval from Central Insecticide Board (CIB). With this launch, cotton farmers will have a new and powerful tool to manage PBW that posed a major challenge in the past few years to cotton farmers across India.