Dapagliflozin going off-patent- NPPA brings Dapagliflozin, Metformin Combination under price control

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.

Also Read: Price War Over Diabetes Drug Dapagliflozin: AstraZeneca Drags 12 Drugmakers To Delhi Court

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.