Ahead of Sitagliptin going off-Patent, NPPA moves to fix retail price of its FDC

Following the recent meeting the apex price regulator, the retail price of the formulation has been fixed for four Fixed Dose Combinations (FDCs) of Sitagliptin and Metformin tablets which include

(i) Sitagliptin 50 mg + Metformin 500 mg tablet,

(ii) Sitagliptin 50 mg + Metformin 1000 mg tablet,

(iii) Sitagliptin 50 mg + Metformin 850 mg tablet and

(iv) Sitagliptin 100 mg + Metformin 1000 mg (extended release) tablet.

The Multidisciplinary Committee of Experts of the NPPA deliberated on the retail price fixation of the popular diabetes drug from various companies during the Authority meeting held on 08.04.2022.

At the meeting, the Committee further noted that the formulation 'Sitagliptin' is on the verge of becoming off-patent. The Committee at recent Multidisciplinary Committee of Experts meeting noted that seventeen applications have been received for retail price fixation of four Fixed Dose Combinations (FDCs) of Sitagliptin and Metformin tablets.

50% haircut on Patent Price-

The Authority noted that the formulation "Sitagliptin" has become/ is on the verge of becoming off-patent and observed that, in line with the decision taken in its 89th meeting dated 28.06.2021, if the calculation is based on six-month prior market data, the price of the patented period would be taken into consideration and hence the price rationalisation due to the expiry of the patent may not pass on to the patients.

(ii)The Authority further noted that the matter was placed before the 40th meeting of the Multidisciplinary Committee of Experts held on 14.03.2022 which in line decision taken in the 89th Authority meeting dated 28.06.2021, recommended to fix the retail price as per the following methodology

"....The Committee observed that the market data of the FDCs of Sitagliptin and Metformin tablet is also available and noted that if the retail price is calculated based on six month prior market data, the price of the patented period would be taken into consideration, and the benefit of price reduction due to medicines which has become/ is on the verge of becoming off-patent would not pass not on to the consumers. The Committee deliberated upon the matter in detail and is of the opinion that the price of drugs be reduced in respect of the drugs which has become/ on the verge of becoming off-patent so as to pass the benefit of price reduction to the consumers and that a reduction of 50% be allowed on the patented component of FDCs i.e. `Sitagliptin' to arrive at the retail price. Accordingly, the Committee recommended to allow retail price for the FDCs of Sitagliptin and Metformin tablet in line with the decision taken in its 33rd meeting held on 21.06.2021. However, where the calculated retail price of the FDC of formulation based on six-month prior market data as per the provisions of DPCO 2013 is lower than claimed price and the calculated price, the Committee recommended that the same would be allowed."

Accordingly , the Committee recommended the retail price of FDCs of Sitagliptin + Metformin Hydrochloride IP tablet for various companies including Alkem Healthsciences, Alkem Laboratories, Exemed Pharma, Emcure Pharma, Zydus Healthcare, Morepen Labs