Globally, India is the 4th largest producer of agrochemicals after the United States, Japan and China and has emerged as the 13th largest exporter of pesticides. It is a major hub of generic pesticides production, which leverages, among other things, the fact that branded molecules, exclusive to the producing companies, are open for larger use after the patent period of 20 years. The fact that 22 such molecules are going to come out of their patent period will substantially expand the offerings of the Indian companies to people at home and abroad alike and may help fetch extra revenue.
Agrochemical sector is deeply interested in the molecules which are going to be off-patented as it creates an opportunity for its own commercial development. Pesticide companies, especially in developing countries, wait for generic active ingredient molecules as it provides huge opportunities for generic manufacturers to provide agrochemicals at a reasonable affordable price for farmers to protect their yield from pests and disease. Moreover, generic pesticides are same in quality of patented pesticides, effectively affordable in price for Indian and global farmers, are Based on the same active substances and work in the same way in the crop as the patented pesticide but cost much less.
Both patented and generic pesticides are subject to the same approval process from the competent authority for registration, a generic pesticide is as safe and effective as the original patented pesticide
There are around 22 pesticide active ingredients which are about to get out of their IPR period in the next ten years i.e., between 2021 and 2030.
The demand for some of these off patented technical grade molecules in the global market is expected to increase drastically. It is expected that the market size of these products will cross over US$ 4.1 billion by 2026.
Generic molecules break the monopoly of a company who had their patent right for about 20 years without any competitor. In fact, monopoly for such a long period is dangerous as there is no control over the price of the product and it can go up as high as the manufacturer wishes. Since the last many years, it has been observed that innovators are becoming more possessive and monopolistic. The generic producers constitute about 30% of the global pesticide industry, mainly due to increase in the number of off-patented molecules and decline in new active ingredients, both of which favor generic pesticides industry which has seen a faster growth as compared to the inventor (R&D based) companies recently.
The reason is that the products like Chlorantraniliprole, Fluropyram, Fluxapyroxad, Cyantranilipore, Bixafen, Sedaxane, Fenpyrazamine and Flupicolide have a huge market. Industry players will have an opportunity, specifically in regulated markets, to choose the generic according to the demand of the market where so many products are becoming off-patent.
In India, these generic products will provide enormous growth to generic manufacturers and also to formulators who are directly or indirectly affected while the products are under IPR.
A word of caution
The increased regulatory pressure in the EU and now increasingly elsewhere is (in general) putting additional pressure on off-patent chemistry to a greater extent than patented chemistry. Companies need to consider more than just sales. Beside factors such as chemistry and regulatory, a key element for any off-patent company post 2020 is a “comprehensive” portfolio of advanced chemistry in order to compete with the “solutions focused” multinationals that can offer a “bundled” seed, trait and crop protection package.
The European Chemicals Agency (ECHA) has amended the Prior Informed Consent (PIC) Regulation, EU 64/2012, to add 27 pesticides and eight industrial chemicals into Annex I, bringing the total to 295. As a result, EU exporters are now required to notify their intentions to export them from 1 November onwards.
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