NPPA panel fixes price of Dapagliflozin, Metformin FDC marketed by Lupin

New Delhi: With the popular antidiabetic drug, Dapagliflozin, going off-patent, the National Pharmaceutical Pricing Authority (NPPA) panel, giving benefit to consumers, has fixed the price of the Fixed Dose Combination (FDC) of Dapagliflozin and Metformin Hydrochloride IP (Extended Release) manufactured by Synokem and marketed by Lupin.

The retail price of each film coated bilayered tablet containing Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin and Metformin Hydrochloride IP (Extended Release) has been fixed at two different strengths of Dapagliflozin as well as two different strengths of Metformin, which include:

• The price of FDC of Dapagliflozin 5 mg and Metformin Hydrochloride IP (extended release form) 500 mg is set at Rs 6.25 per tablet excluding GST.
• The price of each film coated bilayered tablet containing Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 5 mg and Metformin Hydrochloride IP (extended release) 1000 mg is set at Rs. 7.54 per tablet excluding GST.
• The retail price of each film coated tablet containing Dapagliflozin 10 mg and Metformin Hydrochloride IP/USP 500 mg (extended release) is set at Rs. 9.65 per tablet excluding GST.
• The retail price of each film coated tablet containing Dapagliflozin 10 mg and Metformin Hydrochloride IP/USP 1000 mg (extended release) is set at Rs. 11.17 per tablet excluding GST.

This price fixation came during the 34th meeting of the Multidisciplinary Committee of Experts held on 26.7.2021 where the issue of the retail price fixation of  each film coated bilayered tablet containing Dapagliflozin 5 mg and Metformin Hydrochloride IP (extended release) 500 mg manufactured by Synokem Pharmaceuticals and marketed by Lupin for four different strength formulations under Para 5 of the DPCO, 2013 was deliberated.

Regarding the price fixation of the above mentioned fixed dose combination drug, the committee noted that the patent for Dapagliflozin expired on 02.10.2020, making it an off-patent drug.

The panel noted that NPPA, in its 82nd meeting dated 23.12.2020, had approved the retail price of Fixed Dose Combinations (FDCs) of Dapagliflozin and Metformin Hydrochloride (Extended Release) tablets in different strengths, where the authorities had recalled the decision taken in its 72nd meeting dated 20.01.2020 regarding the retail price fixation of Fixed Dose Combinations (FDCs) of Metformin and Vildagliptin tablets

While recalling an earlier recommendation regarding retail price fixation of Fixed Dose Combinations (FDCs) of Metformin and Vildagliptin tablets, the authority had observed,

"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 continuation with the above, the committee further noted,

" the Authority approved retail price fixation of FDCs of Dapagliflozin and Metformin Hydrochloride (Extended Release) tablet by adding 16% retailer margin to the average Price To Retailer (PTR) based on the Form-V data submitted by the companies for whom retail prices were earlier approved for FDCs of Dapagliflozin and Metformin Hydrochloride (Extended Release) tablet in public interest so as to extend the benefit of price reduction due to patent expiry to the consumers."

The Committee also noted that in the similar methodology, the retail price of FDCs of Dapagliflozin 5mg and Metformin Hydrochloride 500mg/ 1000 mg tablet has been fixed for various companies in the 89th Authority meeting held on 28.06.2021.

In light of the foregoing theories, after detailed deliberation, the committee decided to derive the retail price of each film coated bilayered tablet containing Dapagliflozin and Metformin Hydrochloride IP (in extended release form), in accordance with the Authority's decisions taken at its 82nd meeting on December 23, 2020, by taking data as per Form-V submitted by the companies for which the retail price for the Fixed Dose Combinations (FDCs) of Dapagliflozin and Metformin Hydrochloride (Extended Release) tablet earlier approved.

In connection with the above, the Committee noted that the applicant company has claimed price of Rs. 7.00 per tablet excluding GST for the Fixed Dose Combinations (FDCs) of Dapagliflozin 5 mg and Metformin Hydrochloride (Extended Release) 500 mg.

Accordingly, the Committee recommended the retail price of each film coated bilayered tablet containing Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 5 mg + Metformin Hydrochloride IP (in extended release form) 500 mg for Mis Synokem Pharmaceuticals Ltd. (manufacturer) and Mis Lupin Ltd. (marketer) at Rs. 6.25 per tablet excluding GST.

Similarly, for each film coated bilayered tablet containing Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 5 mg and Metformin Hydrochloride IP (in extended release form) 1000 mg, the applicant has claimed a price of Rs. 9.50 per tablet excluding GST.

Accordingly, the Committee recommended the retail price of each film coated bilayered tablet containing Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 5 mg+ Metformin Hydrochloride IP (extended release) 1000 mg for Mis Synokem Pharmaceuticals Ltd. (manufacturer) and M/s Lupin Ltd. (marketer) at Rs. 7.54 per tablet excluding GST.

Further, the committee noted that the applicant company has claimed a price of Rs. 11.00 per tablet excluding GST for each film coated bilayered tablet containing Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10 mg+ Metformin Hydrochloride IP (in extended release form) 500 mg.

Accordingly, the Committee recommended the retail price of each film coated tablet containing Dapagliflozin 10 mg + Metformin Hydrochloride IP/USP 500 mg (extended release) for M/s Synokem Pharmaceuticals Ltd. (manufacturer) and M/s Lupin Lid. (marketer) at Rs. 9.65 per tablet excluding GST.

Lastly, for each film coated bilayered tablet containing Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10 mg and Metformin Hydrochloride IP (in extended release form) 1000 mg, the committee noted, Rs. 13.50 per tablet excluding GST has been claimed by the applicant company.

Accordingly, the Committee recommended the retail price of each film coated tablet containing Dapagliflozin 10 mg + Metformin Hydrochloride IP/USP 1000 mg (extended release) for M/s Synokem Pharmaceuticals Ltd. (manufacturer) and M/s Lupin Ltd. (marketer) at Rs. 11.17 per tablet excluding GST.

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