Ahead of Sitagliptin going off-Patent, NPPA moves to fix retail price of its FDC
New Delhi: With the popular antidiabetic drug Sitagliptin soon expected to go off-patent, the apex drug price regulator, National Pharmaceutical Pricing Authority (NPPA), has moved swiftly to pass on the benefit to the consumers by fixing the price of its fixed-dose combinations (FDC) with Metformin marketed by various companies. In its first go, the NPPA has decided to fix the price of the FDC made by Alkem, Zydus, Exemed/Emcure, Morepen, but more companies as likely to follow as seventeen applications have been received till now for retail price fixation of four Fixed Dose Combinations (FDCs) of Sitagliptin and Metformin tablets.
Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used in conjunction with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. Metformin is a biguanide antihyperglycemic agent and first-line pharmacotherapy used in the management of type II diabetes.
Sitagliptin is a Merck Sharp and Dohme drug that is likely to lose patent in July 2022.
Following the recent meeting the apex price regulator, the retail price of the formulation has been fixed for four Fixed Dose Combinations (FDCs) of Sitagliptin and Metformin tablets which include
(i) Sitagliptin 50 mg + Metformin 500 mg tablet,
(ii) Sitagliptin 50 mg + Metformin 1000 mg tablet,
(iii) Sitagliptin 50 mg + Metformin 850 mg tablet and
(iv) Sitagliptin 100 mg + Metformin 1000 mg (extended release) tablet.
The Multidisciplinary Committee of Experts of the NPPA deliberated on the retail price fixation of the popular diabetes drug from various companies during the Authority meeting held on 08.04.2022.
At the meeting, the Committee further noted that the formulation 'Sitagliptin' is on the verge of becoming off-patent. The Committee at recent Multidisciplinary Committee of Experts meeting noted that seventeen applications have been received for retail price fixation of four Fixed Dose Combinations (FDCs) of Sitagliptin and Metformin tablets.
50% haircut on Patent Price-
The Authority noted that the formulation "Sitagliptin" has become/ is on the verge of becoming off-patent and observed that, in line with the decision taken in its 89th meeting dated 28.06.2021, if the calculation is based on six-month prior market data, the price of the patented period would be taken into consideration and hence the price rationalisation due to the expiry of the patent may not pass on to the patients.
(ii)The Authority further noted that the matter was placed before the 40th meeting of the Multidisciplinary Committee of Experts held on 14.03.2022 which in line decision taken in the 89th Authority meeting dated 28.06.2021, recommended to fix the retail price as per the following methodology
"....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 the patented period would be taken into consideration, and the benefit of price reduction due to medicines which has become/ is on the verge of becoming off-patent would not pass not on to the consumers. The Committee 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% be allowed on the patented component of FDCs i.e. `Sitagliptin' to arrive at the retail price. Accordingly, the Committee recommended to allow retail price for the FDCs of Sitagliptin and Metformin tablet in line with the decision taken in its 33rd meeting held on 21.06.2021. However, where the calculated retail price of the FDC of formulation based on six-month prior market data as per the provisions of DPCO 2013 is lower than claimed price and the calculated price, the Committee recommended that the same would be allowed."
Accordingly , the Committee recommended the retail price of FDCs of Sitagliptin + Metformin Hydrochloride IP tablet for various companies including Alkem Healthsciences, Alkem Laboratories, Exemed Pharma, Emcure Pharma, Zydus Healthcare, Morepen Labs
Sl. No.
| Name of the Formulation / Brand Name | Strength
| Unit | Manufacturer & Marketing Company | Retail Price (Rs.) |
4(xxx)a | Sitagliptin Phosphate+Metformin Hydrochloride Tablet | Each film coated tablet contains: Sitagliptin Phosphate Monohydrate IP 64.25mg is eq. to Sitagliptin 50 mg Metformin Hydrochloride IP 1000mg
| 1 tablet | M/S Alkem Healthsciences (A Unit of Alkem Laboratories Ltd.) /M/S Alkem Laboratories Limited | 20.02 (Note 7) |
4(xxx)b | Sitagliptin Phosphate+Metformin Hydrochloride Tablet | Each film coated tablet contains: Sitagliptin Phosphate Monohydrate IP 64.25mg is eq. to Sitagliptin 50 mg Metformin Hydrochloride IP 500mg
| 1 tablet | M/S Alkem Healthsciences (A Unit of Alkem Laboratories Ltd.) /M/S Alkem Laboratories Limited | 18.34 (Note 7) |
4(xxx)c | Sitagliptin Phosphate+Metformin Hydrochloride(Extended Release) Tablet | Each film coated bilayered tablet contains: Sitagliptin Phosphate eq. to Sitagliptin 100 mg Metformin Hydrochloride IP 500mg (As an extended release form)
| 1 tablet | M/S Alkem Healthsciences (A Unit of Alkem Laboratories Ltd.) /M/S Alkem Laboratories Limited | 20.17(Note 7) |
4(xxx)d | Sitagliptin Phosphate+Metformin Hydrochloride(Extended Release) Tablet | Each film coated bilayered tablet contains: Sitagliptin Phosphate eq. to Sitagliptin 100 mg Metformin Hydrochloride IP 1000mg (As an extended release form)
| 1 tablet | M/S Alkem Healthsciences (A Unit of Alkem Laboratories Ltd.) /M/S Alkem Laboratories Limited | 19.81(Note 7) |
4(xxx)e | Sitagliptin Phosphate+Metformin Hydrochloride Tablet | Each film coated tablet contains: Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50 mg Metformin Hydrochloride IP 500mg
|
1 tablet | M/S Exemed Pharmaceuticals / M/s Emcure Pharmaceuticals Limited | 18. 34 (Note 7) |
4(xxx)f | Sitagliptin Phosphate+Metformin Hydrochloride Tablet | Each film coated tablet contains: Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50 mg Metformin Hydrochloride IP 1000mg
|
1 tablet | M/S Exemed Pharmaceuticals / M/s Emcure Pharmaceuticals Limited | 20.02(Note 7) |
4(xxx)g | Sitagliptin +Metformin Hydrochloride Tablet | Each film coated tablet contains: Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50 mg Metformin Hydrochloride IP 500mg
|
1 tablet | M/S Zydus Healthcare Limited | 18.34 (Note 7) |
4(xxx)h | Sitagliptin +Metformin Hydrochloride Tablet | Each film coated tablet contains: Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50 mg Metformin Hydrochloride IP 1000mg
|
1 tablet | M/S Zydus Healthcare Limited | 20.2 (Note 7) |
4(xxx)i | Sitagliptin +Metformin Hydrochloride Tablet | Each film coated tablet contains: Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50 mg Metformin Hydrochloride IP 500mg
|
1 tablet | M/S Morepen LaboratoriesLimited | 18.34(Note 7) |
4(xxx)j | Sitagliptin +Metformin Hydrochloride Tablet | Each film coated tablet contains: Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50 mg Metformin Hydrochloride IP 1000mg
|
1 tablet | M/S Morepen Laboratories Limited | 20.2 (Note 7) |
Also Read:Cipla gets CDSCO panel okay to manufacture, market Metformin, Sitagliptin FDC
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