NPPAs expert panel recommends retail price fixation of sitagliptin combinations in further 26 applications

New Delhi, July 15, 2022:

Even as the Indian market has started seeing launch of fixed dose combinations (FDCs) comprising anti-diabetic drug sitagliptin, as the patent of Merck Sharp and Dohme (MSD) is expected to expire this month, the expert panel of National Pharmaceutical Pricing Authority (NPPA) has further recommended retail price for the 26 more applications in 11 FDCs of sitagliptin in its latest meeting. The drug price regulator’s decision is expected to bring down the price of the FDC by around 50 per cent on the patented compound of the FDC.

The multidisciplinary committee of NPPA has recommended retail price fixation of sitagliptin and Metformin tablets in 26 applications including from Cadila Pharmaceuticals, Torrent Pharmaceuticals, Micro Labs, Primus Remedies Pvt Ltd, Alembic Pharmaceuticals, Intas Pharmaceuticals, Cipla Ltd, and J B Chemicals and Pharmaceuticals. Reports are that the patent of sitagliptin, a drug patented by Merck Sharp and Dohme, is expected to expire in July, 2022.

While the market data of the FDCs of sitagliptin and Metformin tablet is available, 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 Dede 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.

In a meeting held in June, the panel has recommended price fixation on 34 applications by Indian firms related to the sitagliptin FDCs, and 10 applications in March, this year.

Pharma majors including Zydus Lifesciences and Glenmark Pharmaceuticals has launched the FDCs with sitagliptin in the first half of July.

Zydus, while announcing the launch of the molecule under the brand name Sitaglyn and Siglyn, said that the move will add on to a comprehensive solution for the management of type 2 diabetes by providing access to quality care to the patients at an affordable cost, approximately 60 per cent lesser than the originator.

The company added that sitagliptin is the gold standard in the dipeptidyl peptidase 4 inhibitor (DPP4i) category with over 62% market share in the global market. The drug provides best in class achievement of hemoglobin A1C (HbA1c) goals with proven safety profile. With more than 77 million active patients, India is the diabetes capital of the world after China. As per the data, 67% of these patients are unable to achieve their HbA1c goal.

The oral anti-diabetic market in the country is around Rs. 12,500 crore, of which the DPP4i class of drug has a share of more than Rs. 4,000 crore.

Glenmark has introduced eight different combinations of sitagliptin based drugs under the brand name Sitazit and its variants at affordable price. The company said that its sitagliptin FDCs are priced at around one-third of the cost of its innovator brand in India.

The DDP4i drug will help the patients to manage their glycemic level effectively and bring better compliance. These medicines have low risk of hypoglycemia, provide beta cell protection, offer cardio-renal benefits and are safe for patients with kidney or liver conditions and senior citizens, added the company.

According to a study by the research firm Pronto Consult, over 50 companies are in the process of launching sitagliptin and its combination with Metformin or dapagliflozin in India in near future. This may result in prices falling as low as Rs. 7-8 per tablet or even lower. The number of general practitioners who expressed their willingness to look at sitagliptin after a reduction in price has jumped from 21.6 per cent earlier to 49.7 per cent, said the study. Pharmabiz