AstraZeneca, the US drugmaker that markets its blockbuster cholesterol drug Crestor, says it's taking the company's advice for other companies.
The drugmaker says it's taking the advice of its board of directors and other advisers and has decided to drop Crestor's patent from the US market.
In a statement, AstraZeneca said, "We are aware of the recent discussion among other regulators and other companies regarding the timing of the decision to discontinue the patent for Crestor."
AstraZeneca said the decision "remains subject to judicial review."
The company says it's taking advice from its board and other advisers "as directed by our board of directors and other advisers" and has decided to drop the patent for Crestor from the US market.
The new AstraZeneca agreement, the first in its pipeline to receive approval from the US Food and Drug Administration, will expire in 2027. The company is seeking a new prescription drug license from Merck & Co in the US and is seeking to license its Crestor product through a new pharmaceutical company.
AstraZeneca said in a statement, "We have received prior approval from the FDA for Crestor from AstraZeneca for the treatment of type 2 diabetes in adults, as well as for other uses, including the prevention of cardiovascular events and certain cancers."
The company's announcement comes just five months after the FDA issued a warning to doctors about the risk of dementia and strokes. The agency said some of its earlier warnings were based on information from the FDA but it still has not issued a new warning.
The company said it will continue to review and discuss its Crestor product information and other regulatory submissions, with the first being completed in 2026.
AstraZeneca (NYSE: AZT):New Drug Application
AstraZeneca
Pursuant to the agreement, AstraZeneca will pay a royalty to Merck & Co for the use of Crestor in the US and Canada, the company said. The company will also pay a royalty for the US license to AstraZeneca of its Crestor product from Merck & Co and royalty for its US license to AstraZeneca of its Crestor product from Merck & Co.
AstraZeneca said it has a patent for Crestor that covers the drug from 2006 to 2027. The patent will expire in 2026.
AstraZeneca shares fell 5.2% on the New York Stock Exchange after the announcement.
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AstraZeneca's stock price fell 1.7% on the New York Stock Exchange as of 3:15 p.m. ET on the same day it said it had received final approval from the US Food and Drug Administration for Crestor from Merck & Co and from AstraZeneca.
The company said it will file its new drug application in 2026, or in the form of a "PCT" if it is successful. The application will also be referred to the Federal Food, Drug and Cosmetic Act (FDCA).
AstraZeneca said it has a new drug application filed in the US. It will include data from the FDA and from Merck and will include in the application a statement about the proposed development of Crestor.
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CRESTOR-10-MG-ODN
Rosuvastatin is used to lower high cholesterol (HDL) and low-density lipoprotein (LDL) in adults, teenagers, and young children (aged 12-17). It is also used to treat hyperlipidemia (high cholesterol and triglyceride levels) in adults with familial hypercholesterolemia, and dyslipidemia (fat accumulation and hypertriglyceridemia) in patients with heterozygous familial hypercholesterolemia. It is used to reduce the risk of cardiovascular events in homozygous familial hypercholesterolemia (HFP) and to treat hypertriglyceridemia (high triglyceride levels) in patients with heterozygous hypercholesterolemia. Homozygous for Rosuvastatin hyclate is also used to reduce the risk of developing atherosclerosis (hardening of the arteries) in patients with homozygous familial hypercholesterolemia (HFA). Homozygous for Crestor, also called Rosuvastatin, is also used to lower LDL levels in patients with homozygous familial hypercholesterolemia (HF-HAD). In patients with homozygous familial hypercholesterolemia (HFA), it works by blocking the action of high-density lipoprotein (HDL) cholesterol on the liver. Homozygous for Rosuvastatin hyclate is also used to lower LDL levels in patients with homozygous familial hypercholesterolemia (HFA) who are prescribed at high cholesterol doses. In patients who have homozygous familial hypercholesterolemia (HFA), it works by blocking the action of high-density lipoprotein (HDL) cholesterol on the liver. Homozygous for Crestor hyclate is usually very effective in lowering high cholesterol levels in patients with HFA. However, it may take several months of treatment before you feel better. It may take up to 6 months for the full effect of the drug on your lipid levels. If you need a longer time for the full effect of Rosuvastatin, it is recommended that you wait for the treatment to heal before continuing to take it. Talk to your doctor about the proper duration of treatment before taking Rosuvastatin. If you need to take Rosuvastatin for more than a few months, it is recommended that you wait for the treatment to heal before continuing to take it. If you take Rosuvastatin for more than a few months, you may need to take it for a longer length of treatment (after a maximum of 6 months of treatment). Rosuvastatin may damage the liver and cause liver damage. Before taking this medicine, tell your doctor if you have liver disease or if you have liver problems. Your doctor will probably tell you not to take this medicine. Tell your doctor if you are pregnant or trying to become pregnant. Inactive ingredients in this medicine are: DihydroAPDH (DAPN), Dapoxetine, Daprelid, L-Arginine, Phentolamine, Phentolamine Sodium, Norepinephrine, Prostaglandin E1, Stearic Acid, Eosinophilia IB, Zinc, and selenium. Tell your doctor about all the products you use (including prescription and non-prescription drugs, vitamins, minerals, and herbal products). Generic Rosuvastatin may contain lower levels of SOD or EOSinosterol which may cause liver damage. Tell your doctor if you have ever had a heart attack, or if you have a stroke or heart failure, a heart attack, or a heart rhythm disorder. Tell your doctor if you are allergic to any of the following products. L-Arginine and Phentolamine are not safe for use in children under 12 years of age. Do not take L-Arginine or Phentolamine unless your doctor tells you to do so. Do not take L-Arginine or Phentolamine with any medicines containing L-Arginine. These products may contain inactive ingredients which can cause liver damage. Tell your doctor if you are pregnant or plan to become pregnant. Talk to your doctor about the proper way to treat your liver problems when taking Rosuvastatin.
Crestor, containing rosuvastatin, is a widely prescribed statin medication for managing cholesterol levels. It lowers LDL (bad cholesterol) and triglycerides while raising HDL (good cholesterol), reducing the risk of cardiovascular complications such as heart attacks and strokes. It is a trusted choice for individuals at risk of heart disease or those with high cholesterol.
Crestor works by:
Crestor is a widely prescribed statin medication that is particularly effective for those who have high cholesterol levels, particularly those who have a history of heart disease or high blood pressure. It works by reducing the production of cholesterol in the liver, helping to lower bad cholesterol and triglycerides, thereby lowering the risk of cardiovascular events such as heart attacks and strokes. By acting on the enzymes in the liver that transport cholesterol, Crestor helps to lower bad cholesterol and triglycerides, making it a valuable option for those who need to maintain a healthy lipid profile.
Like any medication, Crestor may cause side effects that individuals should be aware of. Common side effects include headache, muscle aches, indigestion, and flushing. More serious side effects can include muscle pain or tenderness, dark urine, and abnormal liver tests. In rare cases, Crestor can lead to more serious side effects, including muscle pain or weakness, seizures, and increased heart rate or blood pressure. If you experience any of these side effects while taking Crestor, it is important to seek medical attention immediately.
Before taking Crestor, it is important to be aware of certain contraindications and precautions. These conditions may include liver disease or a personal history of liver problems. Additionally, individuals with a history of heart disease, stroke, or blood clots should be cautious when taking Crestor. It is essential to consult with a healthcare provider to determine the appropriate dosage and monitor for any adverse reactions. In some cases, individuals with a personal or family history of liver disease or a personal or family history of liver problems may experience side effects such as nausea, vomiting, or stomach pain.
When taking Crestor, it is important to be aware of the risks associated with Crestor. Crestor is a statin that is often used to lower cholesterol levels in individuals with a high cholesterol level. It works by reducing the production of cholesterol in the liver, which helps to lower bad cholesterol and triglycerides, making it a valuable option for those who need to maintain a healthy lipid profile. Additionally, Crestor can increase the risk of certain types of blood clots, such as those that are caused by smoking or certain types of cancers.
While Crestor is generally well-tolerated, it is important to be aware of the potential side effects and consult with a healthcare provider if any concerning symptoms arise. Additionally, individuals with a history of liver disease or a personal or family history of liver problems should be monitored for any unusual symptoms, which can include nausea, vomiting, abdominal pain, or yellowing of the skin or eyes.
In rare cases, Crestor may lead to liver damage or other serious complications, particularly in those who are on a high cholesterol level. It is important to be cautious when taking Crestor, as it can increase the risk of certain complications such as liver disease or other liver problems. Additionally, individuals with a history of heart disease or other liver problems should be monitored for any signs of liver problems or any symptoms of a heart attack, as these could indicate a more serious condition.
It is important to consult with a healthcare provider if any concerning symptoms arise while taking Crestor, as these can indicate a more serious condition that requires immediate medical attention. Additionally, individuals with a personal or family history of liver disease should be carefully monitored for any unusual symptoms, which can indicate a more serious condition requiring immediate medical attention. In some cases, Crestor may lead to serious complications, such as muscle pain or weakness, seizures, and an increased heart rate or blood pressure.
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