Dapagliflozin going off-patent- NPPA brings Dapagliflozin, Metformin Combination under price control
New Delhi: With the popular antidiabetic drug, Dapagliflozin going off-patent, the apex drug price regulator, National Pharmaceutical Pricing Authority (NPPA) has now moved swiftly to pass on the benefit to the consumers by fixing the price of its FDC with Metformin.
The retail price of the formulation has been fixed in two different strengths of Dapagliflozin as well as to different strengths of Metformin which include
- The price of FDC of Dapagliflozin 10mg and Metformin (ER) 500 mg tablet is set at Rs 10.60 per tablet
- The price of FDC of Dapagliflozin 10mg and Metformin (ER) 1000 mg tablet at Rs 12.26
- The FDC of Dapagliflozin 5 mg and Metformin Hydrochloride IP (in extended-release form) 1000 mg tablet has been priced at Rs 8.35 and
- The price of FDC of one tablet Dapagliflozin 5 mg and Metformin (ER) 500 mg tablet has been set at Rs 6.97
As per the order, price has been fixed for formulations produced by Torrent Pharmaceuticals Limited
The molecule Dapagliflozin has been mired in controversy, ever since the expiry of its genus patent in India in October 2020. With many Indian drug makers including Natco, Zydus, USV and many others moving to launch their generic Dapagliflozin in the market, the innovator, AstraZeneca soon dragged as many as 12 Indian drugmakers to court to prevent them from launching their own generic versions of the drug, claiming that the drug is not off-patient as the 'species patent' of the molecule is valid up to May 15, 2023.
However, in the recent meeting, NPPA has clearly noted that the drug is off-patent since October 2020 and the benefit of the same has to be passed on to the consumers
" The Patent of Dapagliflozin has expired on 02.10.2020 making it an off-patent drug." said the authority adding that " the benefit of price reduction due to medicines going off-patent needs to be passed on to the consumers."
Now in order to decide the price of the drug the Authority in its recent meeting decided to fix the retail price of FDCs of Dapagliflozin and Metformin tablet by adding a 16 percent retailer margin to the average Price to Retailer (PTR). For the same, it referred to the same procedure that it had applied to fix the price of Metformin and Vildagliptin tablet last year
The Authority recalled the decision taken in its 72nd meeting dated 20.01.2020 regarding retail price fixation of Fixed Dose Combinations (FDCs) of Metformin and Vildagliptin tablets in which it emphasized that the benefit of price reduction in case of formulations becoming off-patent ought to be passed on to the consumers in public interest and decided to fix the retail price of FDCs of Metformin and Vildagliptin tablet by adding 16% retailer margin to the average Price to Retailer (PTR) based on Form-V data submitted by the companies for whom retail prices were earlier approved for FDCs of Metformin and Vildagliptin tablets to give the benefits of patent expiry of the drug Vildagliptin to consumers.
In case of Dapagliflozin 5mg FDC, the NPPA also noted that the matter has been referred to the Multidisciplinary Committee of Experts which in its 25th meeting dated 16.12.2020 in which it recommended the retail price as per the following methodology:
a. To derive the price of Dapagliflozin 5 mg tablet by applying the recommendation of Pronab Sen Committee on the retail price arrived at for FDC of Dapagliflozin 10mg + Metformin (ER) 500 mg tablet in line with the decision taken in the 72nd Authority meeting dated 20.01.2020 regarding retail price fixation of Fixed Dose Combinations (FDCs) of Metformin and Vildagliptin tablets.
b. To derive the retail price of Dapagliflozin 5 mg + Metformin Hydrochloride IP (in extended release form) 500/ 1000 mg tablet by adding the derived price of Dapagliflozin 5 mg, as mentioned in (a) above, with the present ceiling price of Metformin ER 500/ 1000 mg tablet, as applicable, after applying the recommendations of Pronad Sen Committee.
With the above methodology, the NPPA approved the prices as mentioned above.
These prices as above have been set currently in the case of FDCs and not in the case of plain Dapagliflozin tablets. At the same time, the authority noting that "the benefit of price reduction due to medicines going off-patent needs to be passed on to the consumers," developments may take place in that light as well.