Lipitor generic availability, cost, and dosage

Generic availability | Lipitor vs. atorvastatin | Cost | Off-label use | How to switch

Would it surprise you to know that almost 25 million adults in the U.S. have total blood cholesterol levels above the recommended range? The truth is – it would surprise many of them, too. High blood cholesterol, or hypercholesterolemia, does not have any symptoms. The only way to diagnose it is to do blood work, looking at specific cholesterol types in the blood. While having high cholesterol may have no symptoms, it is very dangerous. High blood cholesterol is one of the top risk factors for atherosclerotic cardiovascular disease, or ASCVD. ASCVD is one of the most common causes of death among chronic diseases.

Dyslipidemia, a medical term for the imbalance of lipid types in the blood, can occur in children, adolescents, and adults. When your healthcare provider orders blood work labs, they will likely get a report back with four cholesterol indicators: low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides, and a calculation of total cholesterol. The general rule of thumb is you want your LDL and triglycerides as low as possible and your HDL high. HDL is known as the “good cholesterol” because it carries the cholesterol buildup from your arteries to your liver to help the body get rid of it. LDL causes the fatty deposits that block your arteries, which has earned LDL the “bad cholesterol” indicator.

You may assume that a poor diet and lack of physical activity are the root causes of high cholesterol. While you are not incorrect, it’s not as simple as a healthy diet and exercise to avoid dyslipidemia. Genetics plays a strong role in high cholesterol. There is a term for this known as familial hypercholesterolemia, or FH. Someone with FH may have eaten a healthy diet and exercise daily but still have high cholesterol. Science has found a link to mutations in a specific set of genes which leads to FH. You can have blood tests done to test for these mutations. Finding and proactively treating FH can reduce your risk of heart disease by up to 80%.

So how do we treat cholesterol? Today, a group of drugs classified as HMG-CoA reductase inhibitors, better known as “statins”, are the most effective drugs we have to fight high cholesterol. HMG CoA reductase is an enzyme that aids in the formation of cholesterol. By working to increase the number of LDL receptors in the liver, you are increasing the liver’s ability to remove cholesterol from the bloodstream. Prior to statins, cholesterol treatment was fairly limited. A low-fat diet and exercise remain a staple adjunct treatment component to any drug therapy. Bile acid sequestrants, sometimes referred to as bile acid-binding resins, were an early medication option that helped bind cholesterol components and excrete them from the gastrointestinal tract. While effective, the reduction caused by sequestrants typically is much less than the reductions in cholesterol seen with statins.

Lipitor (atorvastatin) was approved by the FDA in 1996 and hit the U.S. market in early 1997. It was the fifth statin drug to come to market in the U.S., but it quickly took the market over within the first few years it was available. It was the first “high-intensity” statin. The intensity of a statin refers to its ability to lower LDL, and Lipitor is known to be able to reduce LDL by 50% or more. Lipitor was once ranked as the top-selling medication on the U.S. market and has been prescribed to millions of people. The generic version of Lipitor became available in 2011 and is one of the most prescribed drugs in the United States today.

Is there a generic for Lipitor?

The generic version of Lipitor is known as atorvastatin, and it has been available on the U.S. market since 2011, when the patent protection for Lipitor expired. It is one of the most prescribed drugs on the market.

Pfizer Inc. still makes available brand-name Lipitor tablets in strengths of 10 mg, 20 mg, 40 mg, and 80 mg. Generic atorvastatin is manufactured by multiple generic manufacturing companies and is available in the same strengths. Due to the fact that Lipitor has been available generically for so long, most insurance plans only provide coverage for the FDA approved generic, and many pharmacies will only have the generic form readily available. The brand name is still available but may be more difficult to locate, and your insurance plan likely will not cover the brand name unless you have prior approval. 

What are the differences between brand name and generic Lipitor?

Brand name Lipitor and its generic equivalent each contain the same active ingredient, atorvastatin calcium. The Food and Drug Administration allows generic manufacturers to start making a generic form of a drug once the patent for the brand name runs out. The generic manufacturers do not have to go through the same extensive clinical trials as the original brand name manufacturer. Still, they must submit an abbreviated new drug application (ANDA) and prove their product is bioequivalent. The generic form must have the same amount of active ingredient and the same onset and duration of action. The availability of multiple generic forms, coupled with the much smaller initial investment by the generic manufacturer, helps drive the cost of generics well below the price point of the original branded product. This also leads third-party payors, such as Medicare and commercial insurance plans, to prefer the generic over the brand name once the generic hits the market. 

Appearance

Brand name Lipitor is manufactured as white, oblong tablets with an imprint corresponding to the milligram strength of that tablet. For example, the 10 mg Lipitor tablet has a “10” imprint on one side. The generic manufacturers each have their own imprint, size, shape, and color. Your pharmacist can verify the imprint for the specific manufacturer of the generic version they dispense.

Dosage Forms

Brand Lipitor and its generics are available in oral tablet forms in strengths of 10 mg, 20 mg, 40 mg, and 80 mg. The dose your healthcare professional chooses will depend upon the amount of cholesterol in your blood, as depicted by your lab tests. 

Clinical Studies

One cohort study compared and followed patients who had been hospitalized for acute coronary syndrome (ACS) and discharged home after surviving. These patients were given either brand Lipitor or atorvastatin and followed for one year to compare outcomes in their medical condition. The primary outcome evaluated was death or recurrence of ACS. Secondary outcomes evaluated were heart failure, stroke, new-onset diabetes, rhabdomyolysis, and renal failure. There were no significant differences in primary or secondary outcomes when comparing those who took brand Lipitor and those who took generic.

How much is generic Lipitor?

What are the off-label uses for Lipitor?

Lipitor has been for purposes not approved by the FDA. Off-label use describes healthcare providers utilizing a drug for which there is evidence of benefit with minimal additional risk but for purposes not evaluated and approved for indication by the FDA.

Slowing the progression of atherosclerosis 

There is data to support that a low dose of atorvastatin can slow the progression of atherosclerosis, the thickening of the arteries. This study evaluated patients whose cholesterol was still in the acceptable range who were dosed with either 10 mg of atorvastatin or a placebo and followed for one year. Their carotid artery thickness was measured. The thickness of the carotid artery decreased one year later in the atorvastatin group, while it increased in the placebo group. This and similar studies have supported the use of atorvastatin and other statins to slow the progression of atherosclerosis. 

Cerebral vasospasm prophylaxis 

Cerebral vasospasm is the prolonged constriction of cerebral arteries. Subarachnoid hemorrhages (SAH) are typically caused by the rupture of an intracranial aneurysm. Cerebral vasospasm after a SAH can lead to long term disability or impairment in patients who survive the initial SAH due to decreased blood flow. Data suggests that treatment with atorvastatin along with a vasodilating drug can reduce cerebral vasospasm and cerebral infarction.

Treatment of chronic heart failure 

There is data to suggest that statin therapy in patients with coronary artery disease (CAD) started prior to the development of heart failure or in the early stages can reduce heart failure hospitalizations and atherosclerotic events. This may not be true in certain populations and in older adults.

Prevention of coronary artery disease after heart transplant 

Statin drugs have become a standard treatment after heart transplants. Studies have shown that early initiation of a statin after transplantation can reduce coronary artery vasculopathy and acute rejection episodes. Barring any contraindications, most heart transplant patients today are started on statin therapy.

How to switch from Lipitor to atorvastatin

In most cases, your pharmacist who dispenses your prescriptions has the authority to substitute an FDA-approved generic for Lipitor when your doctor writes a prescription. In many cases, your insurance company will demand the substitution of brand-name drugs to a generic medication. Your healthcare provider may order your prescription and indicate they do not want the generic substituted. This could lead to higher out-of-pocket costs for you, and the brand name drug may be hard to locate in stock at a pharmacy.

If you have been on brand-name Lipitor and would like to try the generic form, ask your pharmacist if it can be substituted. If the pharmacist indicates the prescriber won’t allow substitution, have a conversation with your prescriber about your reasons for wanting to switch. You do not have to taper or change dosing when switching to the generic. If your prescriber is hesitant to make the change to generic, ask them for their reasons why. A pharmacist can help you to have a conversation with the healthcare provider and address any of their concerns, such as adverse effects and drug interactions. The prescriber may have questions about the inactive ingredients in a generic form, and your pharmacist can help provide more information to address your doctor’s concerns. FDA approved generic drugs are safe and effective. Utilize your pharmacist to help you advocate for generic substitution when that is your desire.