NPPA expert panel recommends retail price for generic sitagliptin combinations

New Delhi, March 28, 2022:

In a move which may increase the price war in the over $2.3 billion anti-diabetic drugs market in the country, the expert panel for National Pharmaceutical Pricing Authority (NPPA) has recommended price fixation against 10 applications for various strengths of fixed dose combinations (FDCs) of anti-diabetic drug sitagliptin and metformin. The panel noticed that the formulation ‘Sitagliptin’ is on the verge of becoming off-patent.

The recommendation was made in a recent meeting where the NPPA’s multidisciplinary committee of experts also recommended retail price for three FDCs of linagliptin and metformin in various strengths, noting that the formulation linagliptin from Boehringer Ingelheim is on the verge of becoming off-patent.

The Committee noted that ten applications has been received for retail price fixation of three FDCs of sitagliptin and metformin tablets, i.e, sitagliptin 50 mg+ metformin 500 mg tablet; sitagliptin 50 mg + metformin 1000 mg tablet and sitagliptin 100 mg + metformin 500 mg (extended release) tablet.

According to reports, the patent of sitagliptin, a drug patented by Merck Sharp and Dohme, is expected to expire in July, 2022. According to market research firm Imarc, the Indian diabetes market reached a value of $2.3 billion in 2019 and is expected to witness strong growth till 2025.

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 patented period would be taken into consideration and benefit of price reduction due to medicines which has become or is on the verge of becoming off-patent would not pass on to the consumers.

After deliberating on the matter, it has opined that the price of drugs be reduced in respect of the drugs which has become or 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 patented component of FDCs, that is, sitagliptin, to arrive at the retail price.

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

Based on this, the price of sitagliptin phosphate monohydrate IP 64.25 mg equivalent to sitagliptin 50 mg + metformin hydrochloride IP 1000 mg at Rs. 20,25 per tablet; sitagliptin phosphate monohydrate IP 64.25 mg equivalent to sitagliptin 50 mg + metformin hydrochloride IP 500 mg at Rs. 18.343 per tablet; sitagliptin phosphate monohydrate IP equivalent to sitagliptin 100 mg + metformin hydrochloride IP 500 mg at Rs. 20.171 per tablet; and sitagliptin phosphate monohydrate IP equivalent to sitagliptin 100 mg + metformin hydrochloride IP 1000 mg at Rs. 19,81 per tablet for Alkem Laboratories. All the prices are excluding goods and services tax (GST).

Sitagliptin phosphate monohydrate IP equivalent to sitagliptin 50 mg + metformin hydrochloride IP 500 mg manufactured by Exemed Pharmaceuticals and marketed by Emcure Pharmaceuticals will have a retail price of Rs. 18.343; while the sitagliptin phosphate monohydrate IP equivalent to sitagliptin 50 mg + metformin hydrochloride IP 1000 mg is fixed with a retail price of Rs. 20.025 for the same company.

Sitagliptin phosphate monohydrate IP equivalent to sitagliptin 50 mg + metformin hydrochloride IP 500 mg from Zydus Healthcare Ltd has been recommended a Rs. 18.343 retail price; while sitagliptin phosphate monohydrate IP equivalent to sitagliptin 50 mg + metformin hydrochloride IP 1000 mg from the same company is recommended with a price of Rs. 20.025 per tablet.

Sitagliptin phosphate monohydrate IP equivalent to sitagliptin 50 mg + metformin hydrochloride IP 500 mg for Morepen Laboratories will also have a price of Rs 18.343 per tablet; and sitagliptin phosphate monohydrate IP equivalent to sitagliptin 50 mg + metformin hydrochloride IP 1000 mg with a retail price of Rs. 20.025 per tablet.

Merck has been producing sitagliptin, which it sells under the brand name Januvia, for the country for several years and has been engaged in patent battles with various Indian companies to curb the introduction of generic equivalent to the market so far. With the patent expected to expire soon, the market is expected to see more generic drugs, with lower price, take their share from the market now. Pharmabiz