Nicotinic Acid Information Research Report

Nicotinic Acid

Information Research Report

1. Basic Information  

2. Domestic Listing Status  

2.1 Import Status  

2.2 Generic Drug Approval  

2.3 Consistency Evaluation Application and Approval Status 

2.4 Generic Drug Application Status  

3. Reference Preparation  

4. Market Situation  

4.1 Medical Insurance Status  

4.2 Centralized Procurement Status  

4.3 Sales Status  

4.4 Bid Price  

5. Active Pharmaceutical Ingredient (API) Information  

5.1 API Pharmacopeia Information  

5.2 API Registration Information  

1. Basic Information

Nicotinic Acid (Niacin), also known as Pyridine-3-carboxylic acid or Vitamin B3, is a white crystalline or crystalline powder that is clinically used to treat hyperlipidemia. The mechanism by which niacin alters the blood lipid profile is not fully understood. It may involve various actions, including partial inhibition of the release of free fatty acids from adipose tissue and increasing lipoprotein lipase activity, which may enhance the removal rate of triglycerides in chylomicrons from plasma. Niacin reduces the liver’s synthesis of VLDL (very low-density lipoproteins) and LDL (low-density lipoproteins) without affecting the fecal excretion of fats, sterols, or bile acids.

Currently, the niacin formulations available on the market in China include niacin tablets, sustained-release niacin tablets, and sustained-release niacin capsules. The reference formulations for niacin published by the national drug regulatory agency are shown in Table 1-1. However, both Nyclin and Niaspan have been withdrawn from the market, and a new application for internationally recognized products listed in the U.S. Orange Book is required as reference formulations.

Table 1-1 Reference Formulations of Niacin Preparations

 2. Domestic Listing Status

2.1 Import Status

As of August 27, niacin preparations have been imported into China.

2.2 Generic Drug Approval

As of August 27, there are 56 production approvals for niacin tablets, 3 for sustained-release niacin tablets, and 1 for sustained-release niacin capsules in China.

2.3 Consistency Evaluation Application and Approval Status

As of August 27, none of the niacin tablets, sustained-release niacin tablets, or sustained-release niacin capsules listed in China have passed or been deemed to have passed the consistency evaluation, nor has any company submitted an application.

2.4 Generic Drug Application Status

As of August 27, no companies have submitted applications for the marketing of niacin tablets or sustained-release niacin capsules.

Currently, one company has applied for listing of niacin sustained-release tablets and is awaiting approval. 

3. Reference Preparations

As shown in Table 1-1, although the national regulatory authority has published the reference formulations for niacin tablets and sustained-release niacin tablets, both products have been withdrawn from the market, and re-application is required.

4. Market Situation

4.1 Medical Insurance Status

Niacin tablets are included in the national medical insurance as a Category B drug and also classified as a Category A over-the-counter (OTC) drug. Sustained-release niacin tablets and sustained-release niacin capsules are classified as Category B prescription drugs under national medical insurance.

4.2 Centralized Procurement Status

Niacin tablets, sustained-release niacin tablets, and sustained-release niacin capsules have not yet been included in centralized procurement.

4.3 Sales Status

From 2019 to 2023, there is no published sales data for sustained-release niacin capsules. Nationwide sales data for niacin tablets from 2015 to 2023 are shown in Table 4-1, while national hospital sales data for sustained-release niacin tablets from 2021 to 2023 (with no available data for pharmacy sales) are shown in

Table 4-2. Table 4-1 Sales of Niacin Tablets Nationwide

Table 4-2 Sales of Sustained-release Niacin Tablets in National Hospitals

4.4 Bid Prices

In July and August of 2024, the bid prices for niacin tablets, sustained-release niacin tablets, and sustained-release niacin capsules in different provinces were published.

5. Active Pharmaceutical Ingredient (API) Information

5.1 API Pharmacopeia Information

According to the search, the Chinese Pharmacopoeia (ChP) includes quality standards information for niacin API.

5.2 API Registration Information

As of August 27, there are 8 registered numbers for niacin API, of which 7 are in status A (active).