The FDA, Generics and Differentiating Authorized from Branded Types

A statement released today from FDA Commissioner Scott Gottlieb, MD, centers on pharmaceutical companies that the FDA claims may be forestalling generic entry into the market.¹

The statement even goes as far as listing dozens of specific companies whom the agency said may be "creating obstacles for generic developers in purchasing samples of their brand drugs." Organizations like the Association for Accessible Medicines lauded the statement from Gottlieb, saying in a statement released to the media that "anti-competitive tactics artificially extend the monopolies on blockbuster brand drugs and keep drug prices high for millions of patients. Many pharmaceutical companies argue that most filled prescriptions are generics, made in large part by the larger pharmaceutical companies themselves.

According to Gottlieb's statement, generic drug developers generally need about 1,500 to 5,000 units of the brand drugs to develop generic products and/or to conduct testing to show that their product is bioequivalent to the brand drug for FDA approval.

His statement got me thinking about pharmacy school, where we spent a lot of time learning about brand versus generics, and the requirements that generics must fulfill to be considered bioequivalent to the brand. It was not until recently that I learned about authorized generics, when a psychiatrist insisted his patient receive a specific manufacturer of generic Strattera, which was the authorized generic.

An authorized generic is exactly the same as the brand name drug, but marketed without the brand name on the label. It can be marketed by the brand name drug company, or another company with permission from the brand company. Although the drug is exactly the same as the brand product, an authorized generic can be sold at a lower cost than the brand name drug.

It’s a little confusing though—what is the difference between a generic and an authorized generic?

A generic drug is made by a company other than the company that made the brand-name drug. Although the generic drug must contain the same active ingredient, conditions of use, dosage form, strength, route of administration, and labeling (with some permissible differences), a generic drug MAY have certain minor differences from the brand name drug, such as different inactive ingredients. For a generic drug to be approved, the company must submit an Abbreviated New Drug Application (ANDA) to the FDA and prove that the drug is bioequivalent to the brand. Additionally, the generic must meet the same standards of quality and manufacturing of the brand drug. (The ANDA application does not have to provide data about safety and effectiveness, because the FDA already has found the drug to be safe. Therefore, obtaining approval of a generic drug is cheaper.)

On the other hand, an authorized generic is exactly the same in all aspects as the brand name drug. The only difference is that the authorized generic does not use the brand name. Since the authorized generic is marketed under the brand drug’s New Drug application (NDA), the authorized generic is not listed in the FDA’s Orange Book. (For more information about the Orange Book, also known as Approved Drug Products with Therapeutic Equivalence Evaluations, click here https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm)

The authorized generic is therapeutically equivalent to the brand name drug because it is exactly the same drug. The holder of the NDA must notify the FDA if they market an authorized generic. The holder of the NDA is allowed to market both the authorized generic and the brand drug at the same time.

The FDA publishes a list of authorized generics and updates the list quarterly.

Authorized generics, which are identical to the brand, should not be confused with branded generics. A branded generic is a generic drug that has gone through the ANDA process, and is assigned a name other than the chemical name.

These branded generic drugs may be developed by a generic drug company, or by the original manufacturer after patent expiration. The branded generic name is owned by the company. The branded generic must be bioequivalent to the original brand product.

When I think of branded generics, I think of the oral contraceptive pill packs with names such as Errin, Jolivette, and Cryselle. Why do birth control pills get these “brand” names instead of sticking with a generic/chemical name?

In addition to the difficulty for patients to remember/pronounce long chemical names of combination estrogen/progesterone products, drug companies want brand name recognition and loyalty, ensuring patients hopefully request the same product each time. Often, your preferred products will vary by your store/chain or supplier. When I worked for a chain, we received different branded generics than we do at the independent.

Some other branded generics I have seen over the years include:

Digitek (digoxin)

Nifedical (nifedipine)

Levoxyl, Levothroid, Unithroid (levothyroxine)

Yuvafem (estradiol vaginal tablet)

Not only do generic companies make branded generics, but because it is a lucrative business, many large pharmaceutical companies that typically manufacture brand name drugs, are now acquiring generic companies to capture some of this business. According to the Association for Accessible Medicines, brand-name companies make about half of the generic drugs on the market.

Branded generics may not be as inexpensive as a regular generic, but they may be less expensive than the original brand.

This is something we see every day, but often don’t have time to stop and think about it or read about it. I hope this was an informative lesson in various types of generics.

Reference

1. Statement from FDA Commissioner Scott Gottlieb, MD, on new agency efforts to shine light on situations where drug makers may be pursuing gaming tactics to delay generic competition [FDA Statement]. Washington, DC. FDA website. May 17, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607930.htm. Accessed May 17, 2018.