Generic Statins

Generic drugs are copies of branded pharmaceutical products priced at a much lower level. While branded statin medications are sold under trademarked names, generic versions are typically sold under the name of the active ingredient in the product. Generic versions of branded statins are approved by the United States Food and Drug Administration (FDA) for safety and efficacy just like branded drugs.

Generic drugs are required by the FDA to have the same active ingredient, the same labeled strength, the same dosage form, and the same administration as the branded pharmaceutical product. Generic manufacturers test their products to demonstrate that the generic drugs are “bioequivalent” to the branded product, which means the active ingredient must work in the same way and in the same amount of time as the branded product. Companies that manufacture and sell generic products in the United States must also comply with the FDA’s strict requirements regarding manufacturing practices. The FDA continually monitors all manufacturing facilities – of both branded and generic pharmaceuticals --to make sure the drugs produced as safe and effective.

What are the Benefits of Generic Statin Drugs?

A generic statin generally costs significantly less than the equivalent branded drug for several different reasons. A branded drug is supplied by only one manufacturer, while the generic versions of that drug may be supplied by many manufacturers. Competition between the generic manufacturers that sell the same product leads to lower prices.

Generic drug companies are able to sell their products at lower prices because they do not advertise their products to doctors or patients like many branded companies. Instead, generic companies rely on state laws which allow pharmacies to substitute the generic version of the product for the branded version, unless the doctor or patient objects to the substitution. In addition, the generic company can rely on verification tests conducted by the branding company to show that the active ingredient and its strength are safe and effective, thus lowering regulatory approval costs for the generic company.

Generic statins at a lower price than Brand Name

For instance, a 2010 check of a popular online pharmacy showed Zocor was substantially more expensive than simvastatin. This is over three years after Merck's patent for simvastatin expired. The branded Zocor is about four times as expensive. (For the 10 mg dosage, $3/pill vs. $0.67/pill.) A Consumer Reprts article said that Medicare could save billions of dollars by switching to generic statins. A British study concluded that widespread use of generic statins could be effective in achieving nationwide lower cholesterol as branded drugs.

When are Generic Drugs Available?

Generic drugs may only be approved by the FDA once the patents on the branded product have expired, unless the generic manufacturers can show that its product and manufacturing process does not violate the patents held by the branded company. Patents are usually valid for 20 years from their issuance. Most branded companies, however, will seek patents on their products before the product is approved by the FDA and able to be sold in the United States. As a result, the amount of time before a generic version of any particular branded product is available varies based upon the product.

If the generic manufacturer wants to sell its product before the patents on the branded product have expired, it must show that its version of the product and its manufacturing method do not violate the patents held by the branded company or that the patents of the branded company are not enforceable. If the generic company is successful in challenging the patents, it receives a period of exclusivity of 180 days. During those 180 days, the FDA cannot approve any other generic version of that product.

“Authorized Generics”?

Authorized generics are the branded product sold without the trademarked name. Authorized generics may be sold by the branded company through a subsidiary or by a third party with a contractual relationship with the branded company. Authorized generics are the exact same product, manufactured by the same company as the branded product, so they do not require a separate approval from the FDA. The 180-day exclusivity period does not apply to authorized generics. Dr. Reddy's Laboratoris makes an authorizeg generic version of Zocor. Other companies can make simvastatin since Merck's patent expired, but they are not "authorized generic".

Drawbacks to using Generic Statins?

Generic drugs are bioequivalent to the branded product, but they are not identical. The FDA’s standard for bioequivalence states that the generic drug company must demonstrate that there is no “significant difference” between the generic product and the branded product in terms of the way the product works in the body. While some patients may claim or believe that there is a difference between branded and generic versions of the same drug, when clinical study participants are not aware of this distinction, the two versions perform equally across studies.

Further, although generic drugs contain the same active ingredient as the branded product, the inactive ingredients may be different. As a result, they may look slightly different. Generic drugs may be a different color, different flavor, or have a different shape than their branded equivalent.

Generic drugs are not available for all statins. The most widely used statin, Lipitor, is not available in generic form because Pfizer owns the patent.

Importing statins from other countries

News story: Not all drugs are the same - New York Times