Indian Trio Receive Approval for Generic Versions of Blockbuster Cholesterol Pill Crestor
India’s Aurobindo Pharma, Sun Pharma and Glenmark Pharmaceuticals received approval from the U.S. Food and Drug Administration (FDA) to market and manufacture cheaper, generic version of AstraZeneca’s rosuvastatin calcium tablets, Crestor which is a hypolipidemic drug used to lower cholesterol.
The regulatory approval was received by the three companies to manufacture and market the generic versions of the drug in four different doses of 5 mg (base), 10 mg (base), 20 mg (base) and 40 mg (base).
Rosuvastatin calcium tablets regulate and control the cholesterol and fats (triglycerides) in blood, which if build up in the arteries for a long time blocks the blood flow to the heart, brain and other parts of the body. Therefore, this drug regulate the cholesterol level and prevent heart disease and strokes in patients with high cholesterol risk.
Figure 1. Crestor 20mg, 30 Tablets packaging (photo credit: rxmexicoonline.com).
Crestor act as a selective and competitive inhibitor of the rate-limiting enzyme, HMG-CoA reductase which converts 3-hydroxy-3-methylglutaryl coenzyme A to cholesterol precursor, mevalonate. Studies suggest that rosuvastatin have specific and high uptake capacity, for action in the liver (the target organ for cholesterol lowering). Therefore, firstly, it increases the number of hepatic low-density lipoprotein (LDL) receptors on the cell-surface to increase the uptake and degradation of LDL. Secondly, it inhibits the production of very-low-density lipoprotein (VLDL) in the liver. Therefore, it reduces the total number of VLDL and LDL particles and controls the lipid modifying effect.
Figure 2. Molecular mechanism of statins (photo credit: Jahanzaib Sheikh, Slideshare.net).
Crestor is the patented product of AstraZeneca. As the patented period of AstraZeneca will be soon expired, the Indian firms applied for an ANDA (Abbreviated New Drug Application) for this year.
Out of the three companies Aurobindo Pharma was the first one to file for the approval. In a statement released, the company stated that “Aurobindo was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification; therefore, Aurobindo is eligible for 180 days of generic drug shared exclusivity. The product is launched in the US Market.”
The other two pharma i.e. Sun and Glenmark stated that their respective subsidiary arms in US have also received the approvals for the drug’s generic version.
Although the demand for the original drug and its generic versions are high, the drug was found to have adverse events and FDA has issued warning on the use of the drug if any liver problem occurs.
According to IMS Health report, the annual sales of Crestor in USA was around $6.78 billion. The approval of the generic version has definitely affected the sales rate of the AstraZeneca’s Crestor.
Several other pharma companies either have tentative approvals or are in the process to file for the approval of generic Crestor. Indian Pharmaceuticals include Torrent Pharmaceuticals and Alkem Laboratories. Outside India, drugmakers in competition are Mylan, Apotex, Teva Pharmaceutical, Endo International Plc-owned Par Pharmaceutical and Sandoz AG have applications for approval too, according to FDA data.
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