Last Updated on January 6, 2024 by The Health Master
Even as the Indian market has started seeing the launch of fixed-dose combinations (FDCs) comprising the anti-diabetic drug sitagliptin, as the patent of Merck Sharp and Dohme (MSD) is expected to expire this month, the expert panel of the 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 percent 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:
- Cadila Pharmaceuticals,
- Torrent Pharmaceuticals,
- Micro Labs,
- Primus Remedies Pvt Ltd,
- Alembic Pharmaceuticals,
- Intas Pharmaceuticals,
- Cipla Ltd,
- JB Chemicals and Pharmaceuticals.
Also read: NPPA’s panel recommends fixing retail price of sitagliptin FDCs on 34 applications
Reports state that the patent for sitagliptin, a drug patented by Merck Sharp and Dohme, is expected to expire in July 2022.
While the market data for the FDCs of sitagliptin and metformin tablets are available, 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 would be realized.
After deliberating on the matter, it has been opined that the price of drugs be reduced in respect of those drugs which have become or are 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 percent is allowed on the patented component of FDCs, that is, sitagliptin, to arrive at the retail price.
In a meeting held in June, the panel 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, launched the FDCs with sitagliptin in the first half of July.
Zydus, while announcing the launch of the molecule under the brand names Sitaglyn and Siglyn, said that the move will add to a comprehensive solution for the management of type 2 diabetes by providing access to quality care to patients at an affordable cost, approximately 60 percent less 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 a 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 crores, of which the DPP4i class of drugs has a share of more than Rs. 4,000 crores.
Glenmark has introduced eight different combinations of sitagliptin-based drugs under the brand name Sitazit and its variants at affordable prices.
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 manage their glycemic levels effectively and bring better compliance.
These medicines have a 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 the 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 percent earlier to 49.7 percent, said the study.
Latest on National Pharmaceutical Pricing Authority (NPPA)
Latest notifications – DPCO / NPPA
Latest Notifications: EC Act (Essential Commodities Act)
FAQs – On DPCO: Drugs (Prices Control) Order, 2013
CDSCO releases draft guidance documents on IVD Medical Devices
Highlights: Drugs, Medical Devices and Cosmetics Bill 2022
USFDA approves first eye drop that can eliminate the need for reading glasses
Quality certificates of Medical Devices by other entities not a replacement for license: CDSCO
Drug alert: 26 out of 1096 samples declared as NSQ in June 2022
DCGI grants marketing authorisation for vaccine against Cervical Cancer
Cipla Vs Sun Pharmaceuticals: “Respules” issue in court – Lets know the matte
USFDA considers to okay Over-The-Counter Birth Control Pill
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
