What are generic drugs?

A generic drug is a copy that is the same as a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and intended use.

Are generic drugs as safe as brand-name drugs?

Yes. FDA requires that all drugs be safe and effective. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their brand-name counterparts.

Are generic drugs as strong as brand-name drugs?

Yes. FDA requires generic drugs to have the same quality, strength, purity and stability as brand-name drugs.

Do generic drugs take longer to work in the body?

No. Generic drugs work in the same way and in the same amount of time as brand-name drugs.

Emboldened by favorable court rulings and the need to gain an early foothold in the market, generic drug developers are increasingly challenging lucrative drug patents.

In many cases those challenges have been coming in the form of at-risk launches, where a generic version of a patented drug is sold before the patent expires.

Heavyweights including Teva Pharmaceutical Industries Ltd., Barr Pharmaceuticals Inc. and Mylan Pharmaceuticals Inc. have been growing bolder when it comes to this strategy, as the risk-reward equation seems to have shifted to their favor.

“I think they’ve just gotten a lot smarter as an industry,” said WR Hambrecht analyst Andrew S. Forman. “Generics have the sympathy, pricing advantage and generally have facts on their side; there’s been settlements, but no losses.”

Often, he said, pharmaceutical companies will try to gain patent extensions to stave off generic competition. With more insurers and Medicare pushing members to generic options because of the price difference, the market seems to have swayed. Generic drug developers now claim more than two-thirds of all prescriptions, up from less than half 10 years ago.

The most recent salvo came from Teva, the largest generic drug developer in the world. The Israel-based company had challenged Wyeth’s patent on the blockbuster heartburn drug Protonix. That patent isn’t due to expire for three more years, but in December, Teva launched its generic version over the course of several days, before ceasing shipments as part of a deal.

Protonix sales reached $1.9 billion in 2007. Drugstore.com currently lists generic Protonix at a 7.7 percent discount to the branded version. A similar discount currently exists for Lotrel, a blood pressure drug made by Novartis, for which Teva enjoys market exclusivity with a generic.

Other disputes involve Forest Laboratories Inc. and generic drug developers Teva and Barr over the Alzheimer’s disease treatment Namenda. Endo Pharmaceuticals Holdings Inc. and Penwest Pharmaceuticals Co. are suing Impax Laboratories over plans to make a version of the pain reliever Opana ER.

Several pharmaceuticals companies, including Forest and Wyeth, declined comment on the ongoing patent challenges.

“There are just more Paragraph IV (patent dispute) challengers than years ago,” said Mike Dzwonczyk, a patent attorney at Sughrue Mion PLLC. “The likelihood of sharing market space is much higher now than it ever used to be.”

While generic companies run the risk of paying triple-damages if they conduct an at-risk launch and then lose the patent dispute, several recent court cases have gone in favor of generics, he said. It has become harder for pharma to prove a company willfully infringed a patent, for example, lessening the risk of triple damages.

Also, the downside risk to losing a case has become smaller for large companies like Teva, which can often offset any future losses with big sales gains early on.

Most prescription drugs placed on the market are given trade names (also called proprietary, brand, or specialty names) to distinguish them as being produced and marketed exclusively by a particular manufacturer. In the United States, these names are usually registered as trademarks with the Patent Office; this gives the registrant certain legal rights with respect to the use of the name. A trade name may be registered for a product containing a single active ingredient, with or without additives, or for one containing two or more active ingredients.

A drug marketed by several companies may have several trade names. A drug manufactured in one country and marketed in many countries may have different trade names in each country.

Throughout this book, generic (nonproprietary) names have been used whenever possible. However, because trade names are used commonly and may be more readily recognized, the generic drugs mentioned in this book are listed below in alphabetic order along with many of their trade names. A second table follows, listing the trade names in alphabetic order along with their generic name.

With few exceptions, the trade names in these tables are limited to those marketed in the United States. These tables are by no means all-inclusive, and no effort has been made to list every trade name in current use for each drug. The inclusion of a drug in these tables does not indicate approval of a drug’s use, nor does it imply that a drug is effective or safe. Many drugs are marketed almost exclusively under their generic name. Including a trade name of such a drug in these tables does not indicate an endorsement or preference for the trade name version over the generic version.

Whether it is best to use a trade or a generic version of a drug may be a complex decision. It is best to discuss such matters with a doctor or pharmacist.