Last Updated on January 5, 2024 by The Health Master
NPPA
The National Pharmaceutical Pricing Authority (NPPA) has taken a significant step in regulating the pricing of anti-diabetes drug combinations, particularly those containing sitagliptin and dapagliflozin.
The Multidisciplinary Committee (MDC) of Experts, advising the NPPA, has recommended retail prices for 24 such drug combinations, whose exclusive patent rights for marketing in India recently expired.
Retail Price Fixation for Sitagliptin Combinations
The MDC focused on 10 formulations that included sitagliptin 50 mg, metformin hydrochloride 1000 mg, and glimepiride 1 mg. The following key points were observed:
- Micro Labs Ltd claimed a price of Rs. 11.61 per tablet.
- Other applicants, including Abbott Healthcare, Lupin, Mankind Pharma, Glenmark Pharmaceuticals, Emcure Pharmaceuticals, Torrent Pharmaceuticals, Eris Lifesciences, and Dr Reddy’s Laboratories, saw prices fixed around Rs. 13.35 per tablet.
The prices were determined based on data available for April and May 2023, as the applications were filed in November and December.
Additional Formulations and Price Recommendations
Another set of 10 formulations containing sitagliptin 50 mg, metformin hydrochloride 1000 mg, and glimepiride 2 mg were considered:
- Micro Labs claimed a lower price of Rs. 13.39 per tablet.
- Torrent Pharmaceuticals proposed Rs. 14.30 per tablet, recommended by the Committee.
For nine other formulations, the price was set at Rs. 15.03 per tablet for all applicants, including Abbott Healthcare, Glenmark Pharmaceuticals, Mankind Pharma, Lupin Ltd, Emcure Pharmaceuticals, Dr Reddy’s Laboratories, and Eris Lifesciences.
Dapagliflozin Combinations Retail Prices
The MDC also addressed combinations containing dapagliflozin, recommending prices for Sun Pharma Laboratories:
- For dapagliflozin 10mg, glimepiride 2 mg, and metformin hydrochloride (as extended release) 500 mg, the price was recommended at Rs. 15.15 per tablet.
- The combination with metformin hydrochloride (as extended release) 1000 mg was set at Rs. 16 per tablet.
Another combination, dapagliflozin 10mg, glimepiride 1 mg, and metformin hydrochloride (as extended release) 500mg, was priced at Rs. 13.47 per tablet, and for the 1000 mg variant, it was Rs. 14.50 per tablet.
Background on Patent Expiry
It’s crucial to note that sitagliptin’s patent, held by MSD Pharmaceuticals, expired on July 5, 2022, leading to various generic manufacturers entering the market and subsequently reducing drug prices.
The NPPA also implemented a methodology, during this period, resulting in a 50 percent reduction in the prices of components with recently expired patents.
Dapagliflozin, whose patent expired on October 2, 2020, experienced a similar trend with multiple generic combinations entering the market, ultimately lowering retail prices.
Astra Zeneca initially held the patent for dapagliflozin, with Sun Pharma and Abbott Healthcare acting as license holders.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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