Panel Recommends Retail Price Of Dapagliflozin Generic Drugs Even As AstraZeneca Fights For Patent Protection

A six-member multidisciplinary committee of experts has recommended retail price of various strengths of type II diabetes drugs containing dapagliflozin combinations to be marketed by Indian pharma companies including Lupin Ltd, Primus Remedies Pvt Ltd and Indoco Remedies, manufactured by Synokem Pharmaceuticals Ltd. This comes at a time when the multinational drug major AstraZeneca is taking various measures to protect the patent exclusivity of dapagliflozin it sells in the country.The NPPA Committees has fixed the minimum price for certain combinations including dapagliflozin 5 mg to Rs. 6.25 per tablet excluding Goods and Services Tax.The Committee of experts noted that the patent of dapagliflozin has expired on October 2, 2020, making it an off-patent drug. It also observed that in an earlier meeting on December 23, 2020, the NPPA has approved retail price of fixed dose combinations (FDCs) of the dapagliflozin along with metformin hydrochloride (extended release) after drawing attention to the price fixation of vildagliptin tablets where the Authority emphasised on the need to pass on the benefit of price reduction in case of formulations becoming off-patent, to the consumers in public interest.In a similar methodology, it has fixed the retail price of FDCs of dapagliflozin 5 mg and metformin hydrochloride 500 mg/1000 mg tablets for various companies in the 89th Authority meeting held on June 28, 2021. The retail price was fixed at Rs 6.25 per tablet.The patent expiry of dapagliflozin is expected to bring down the prices of diabetes drugs further, which has already started seeing a churn following the patent expiry of Novartis’ vildagliptin, sold as Galvus, on December 9, 2019.Dapagliflozin is an oral medicine, from a class of medicines named sodium-glucose co-transporter 2 (SGLT2) inhibitors. In February this year, the company announced that it has received marketing authorisation for the drug for treatment of patients of chronic kidney disease up to State III.AstraZeneca India, recently said that it is independently marketing dapagliflozin, the combinations of dapagliflozin and metformin as well as dapagliflozin and saxagliptin in India under the brand names Forxiga, Xigduo, and Qtern respectively. It has been marketing the drugs through Abbott Healthcare and Sun Pharmaceuticals in the country.In May 28, this year, it has severed the distribution agreement with Abbott Healthcare Pvt Ltd for distribution of dapagliflozin, which was under the brand name Gledepa, while Sun Pharma reportedly acquired patent license from the multinational firm to manufacture and commercialise the drug and its combinations in the country.In the latest meeting on July 26, 2021, the committee recommended the retail price of each film coated bilayered tablet containing dapagliflozin propenediol monohydrate equivalent to dapagliflozin 5 mg + metformin hydrochloride IP (in extended release form) 500 mg for Delhi-based Synokem Pharmaceuticals (manufacturer) and Mumbai-based Lupin Ltd (marketer) at Rs. 6.25 per tablet excluding GST.Retail price of dapagliflozin 5 mg and metformin hydrochloride (extended release) 1000 mg tablet was fixed at Rs 7.54 per tablet excluding GST. For the FDC dapagliflozin 10 mg and metformin hydrochloride (extended release) 1000 mg tablet, the company claimed Rs. 13.50 per tablet, but the Committee recommended Rs. 11.17 per tablet, which stands at the upper range of retail price fixed for the drug during the meeting.Similarly, retail prices were fixed for various strengths of dapagliflozin combinations which are to be marketed by Mumbai-based Indoco Remedies and Secunderabad-based Primus Remedies Pvt Ltd.The multinational drug major has been locking horns with various Indian manufacturers in the recent past to block them from manufacturing and marketing medicines with dapagliflozin as an ingredient. It claims that while one of the patents has expired, another patent specifically on the medicine is still valid. In 2020, according to reports, it filed patent litigation with 12 generic firms to establish its patent rights for dapagliflozin.In a recent patent infringement litigation between AstraZeneca and nine Indian pharmaceutical companies, the generic competitors argued that while Sun Pharma Laboratories Limited and Abbott Healthcare Private Limited, the distributors of AstraZeneca's said diabetes medicine in India till recently, were marketing it under various brand names and various disclosed combinations at Rs. 54.40 paise for a 5 mg dose and at Rs. 57.29 paise for a 10 mg dose, the generic players were selling their drug for Rs. 13.90 paise for 5 mg dose and Rs. 17.50 paise for a 10 mg/ dose. In the prevalent coronavirus pandemic times, the probability of a diabetic person being afflicted with the virus is exponentially high, they argued.AstraZeneca claims that it had two patents, Indian Patent No. 205147 (IN 147) and Indian Patent No.235625 (IN 625), of which the latter is specifically for the drug. Both, IN 147 and IN 625 were granted to Bristol Myers Squibb Company, which in February 2014, assigned the rights to AstraZeneca AB, Sweden. The dates of grant and expiry of IN 147 are March 15, 2007 and October 2, 2020 and the dates of grant and expiry of IN 625 are July 9, 2009 and May 15, 2023 respectively.A Division Bench of Delhi High Court in an order on July 20, 2021, refused to allow interim relief to AstraZeneca in its fight against nine Indian firms - Intas Pharmaceuticals, Alkem Laboratories, Zydus Healthcare, Eris Lifesciences, USV Pvt Ltd, Torrent Pharmaceuticals, MSN Laboratories, Micro Labs and Ajanta Pharma. These companies also initiated post-grant opposition, revocation proceedings or counter-claims against IN 625.The suits were filed by AstraZeneca after lapsing of the validity of IN 147, to restrain the Indian competitors from manufacturing, selling or otherwise dealing in any manner the product comprising the compound, which it argued, will be amounting to infringement of IN 625.

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