The National Pharmaceutical Pricing Authority (NPPA)’s expert panel has fixed the price of an anti-diabetic combination drug consisting of linagliptin, patented by Boehringer Ingelheim, on eight applications filed by Indian manufacturers and marketers, as the medicine is "on the verge of becoming off-patent.”

The anti-diabetic market, which is over Rs. 14,000 crore according to 2021 reports, has been seeing increased competition owing to some of the major drugs going off-patent in recent years, and the new move is expected to add momentum to this competition in the market.

While the therapeutic category of all these FDCs is anti-diabetic, the same has been stated inadvertently as antihypertensive in the applications, said the panel.

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A meeting of the multidisciplinary committee of experts, under the NPPA held on March 14, under the conveyor ship of Manmohan Sachdeva, Advisor (Cost), the Committee considered eight applications it has received for retail price fixation of three fixed dose combinations (FDCs) of linagliptin and metformin tablets.

This includes linagliptin 2.5 mg combination with Metformin 500 mg, 850 mg and 1000 mg tablet combinations.

The Committee noted that the formulation linagliptin has become/on the verge of becoming off-patent, it said. According to reports, Boehringer Ingelheim’s patent for linagliptin may expire in the year 2025.

The Committee observed that the market data of the FDCs of linagliptin and metformin tablets is also available and noted that if the retail price is calculated based on six month prior market data, the price of patented period would be taken into consideration and benefit of price reduction due to medicines which has become/is on the verge of becoming off-patent would not pass to the consumers.

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The experts 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 per cent be allowed on the patent component of FDCs i.e. ‘Linagliptin’ to arrive at the retail price.

“Accordingly, the Committee recommended to allow retail price for the FDCs of linagliptin and metformin tablets in line with the decision taken in its 33rd meeting held on June 21, 2021,” said the minutes of the panel meeting. On June 21, 2021, the Committee recommended retail price fixation of the FDCs of metformin + saxagliptin tablet, as the patent of formulation saxagliptin expired on March 5, 2021.

If the calculated retail price of FDC based on the six month prior market data as per the provisions of Drug (Prices Control) Order, 2013, is lower than the claimed price and the calculated price, the Committee recommended that the same would be allowed.

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According to this, each film coated tablet containing linagliptin 2.5 mg + metformin hydrochloride IP 500 mg for Natco Pharma Ltd as marketer and Optimus Pharma Pvt Ltd as manufacturer was fixed at Rs. 8.04 per tablet excluding GST, while the derived retail price of linagliptin 5 mg as per July 2021 data was at Rs. 44.81 per tablet.

While the worked out retail price was Rs. 14.65 per tablet, Natco has claimed only Rs. 8.04 per tablet and this has been recommended by the expert panel. For the same combination, Micro Labs Ltd has claimed a retail price of Rs. 10.63 per tablet and the same was allowed.

Application from Emcure Pharmaceuticals as marketer and MSN Laboratories as manufacturer; and Eris Lifesciences Ltd as marketer and MSN Laboratories Pvt Ltd as manufacturer, for the same combination and strength was fixed as Rs. 14.65 per tablet, as against the claimed retail price of Rs. 23.93 per tablet.

For the FDC comprising linagliptin 2.5 mg and metformin hydrochloride IP 1000 mg for Natco Pharma and marketer and Optimus Pharma Pvt Ltd as manufacturer is recommended to be fixed at Rs. 8.37 per tablet excluding GST, while the retail price worked out by the expert panel was Rs. 16.33 per tablet.

For the same combination and strength, for Emcure Pharmaceuticals as marketer and MSN Laboratories as manufacturer, the retail price was fixed at the worked out price of Rs. 16.33 per tablet, as compared to the claimed price of Rs. 24.91 per tablet.

Micro Labs Ltd has claimed Rs. 11.52 per tablet for the same FDC strength, and this has been recommended by the experts now.

The FDC of linagliptin 2.5 mg and metformin hydrochloride IP 850 mg from Emcure Pharmaceuticals as marketer and MSN Laboratories Pvt Ltd as manufacturer, was fixed at Rs. 15.451 per tablet, as against the claimed price of Rs. 24.38 per tablet.

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