Ahead of Linagliptin going off-patent, NPPA fixes retail price of its FDC with Metformin

Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor used to manage hyperglycemia 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.

Following the recent meeting the apex price regulator, the retail price of the formulation has been fixed for three Fixed Dose Combinations (FDCs) of Linagliptin and Metformin tablets which include:

i) Linagliptin 2.5 mg+ Metformin 500 mg tablet,

(ii) Linagliptin 2.5 mg+ Metformin 850 mg tablet and

(iii) Linagliptin 2.5 mg + Metformin 1000 mg tablet.

This came after the Multidisciplinary Committee of Experts deliberated on the retail price fixation of the popular diabetes drug from various companies during the Authority meeting held on 08.04.2022.

50% haircut on Patent Price-

At the meeting, the Committee further noted that the formulation 'Linagliptin' 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 expiry of the patent may not pass on to the patients.

The Authority further noted that matter was placed before the 40th meeting of the M ultidisci plinary Comm itt ee of Experts held on 14.03.2022 which in line with decision taken in the 89th Authority meeting dated 28.06.2021, recommended to fix the retail price as per the following method ology:

" ..... The Committee observed that the market data of the FDCs of Linagliptin and Metformin tablet is also available and noted that if the retail price is calculated ba sed on six month prior market data, the price of patented period would be taken into consideration and benefit of price reductio n 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 matte r in detail and is of the opinion that the price of drugs be reduced in res pect 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. 'Linag lipti n' to arrive at the retail price. Accordingly, the Committee recommended to allow retail price for the FDCs of Linagliptin 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 formu lation 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 Natco Pharma, Emcure Pharmaceuticals, Eris Lifesciences and Micro Labs.

In view of the above, the retail price of each film coated tablet containing Linagliptin 2.5mg and Metformin Hydrochloride IP 500mg manufactured by Optimus Pharma and marketed by Natco Pharma has been fixed at Rs 8.04 per tablet excluding GST.

The retail price of each film coated tablet containing Linagliptin 2.5mg and Metformin Hydrochloride IP 500mg manufactured by MSN Laboratories and marketed by Emcure Pharmaceuticals has been fixed at Rs 14 .65 per tablet excluding GST .

The retail price of each film coated tablet containing Linagliptin 2.5mg and Metformin Hydrochloride IP 500mg manufactured by MSN Laboratories and marketed by Eris Lifesciences has been fixed at Rs 14.65 per tablet excluding GST.

The retail price of each film coated tablet containing Linagliptin 2.5mg and Metformin Hydrochloride IP 500mg manufactured and marketed by Micro Labs Limited has been fixed at Rs 10.63 per tablet excluding GST.

The retail price of each film coated tablet containing Linagliptin 2.5mg and Metformin Hydrochloride IP 1000mg manufactured by Optimus Pharma and marketed by Natco Pharma has been fixed at Rs 8.37 per tablet excluding GST.

The retail price of each film coated tablet containing Linagliptin 2.5mg and Metformin Hydrochloride IP 1000mg manufactured by MSN Laboratories and marketed by Emcure Pharmaceuticals has been fixed at Rs 16.33 per tablet excluding GST.

The retail price of each film coated tablet containing Linagliptin 2.5mg and Metformin Hydrochloride IP 1000mg manufactured and marketed by Micro Labs Limited has been fixed at Rs 11.52 per tablet excluding GST.

The retail price of each film coated tablet containing Linagliptin 2.5mg and Metformin Hydrochlori de IP 850mg manufactured by MSN Laboratories and marketed by Emcure Pharmaceuticals has been fixed at Rs 15.45per tablet excluding GST.