Delhi high court paves way for affordable anaemia drug

MUMBAI: Decks have been cleared for the entry of affordable versions of intravenous anaemia therapy, ferric carboxymaltose. The Delhi high court has rejected the application by MNC drug firm Vifor, seeking an injunction against Dr Reddy’s, MSN Labs and Corona Remedies, for manufacturing and marketing its generic versions. The development potentially paves the way for more companies including Cipla, to enter the market, bringing down prices further, industry and legal experts told TOI.

Ferric Carboxymaltose is an intravenous treatment of iron deficiency when oral iron preparations are ineffective. The drug is available in hospitals for around Rs 3,500. With generic versions and more launches now, the price could go down to under Rs 1,000, an over 50% reduction from the existing MRP. It loses patent protection on October 20, 2023. Over the last few years, and more recently in April, the Swiss company sued over a dozen players including La Renon, Suven, Alembic, Cipla and JB Chem to block the drug’s entry. Interestingly, certain firms were successful in entering the market over a period of time. Some had launched the product which was being manufactured by Mumbai-based BDR Pharma, experts say.

In January 2012, Vifor licensed Pune-based Emcure Pharmaceuticals to commercialise the drug, which is marketed as Encicarb (now also sold under the brand names Ferium and Orofer FCM). It also has a marketing tie-up with Mumbai-based Lupin. Vifir claimed that the patent was for the product per se, and anyone making it would infringe it.The judgment, a copy of which was accessed by TOI, said, “Since claim 1 is a ‘product-by-process’ claim, use of different process by the defendants to produce FCM cannot amount to infringement, as alleged. Defendants have arrived at a process, which is different from the process of Vifor and therefore cannot be accused of infringing. ”
However, a market player said the case has dragged on for several years, hence there isn’t much commercial or patient benefit now.