FDA Approves Six New Generics for Common Brand-Name Drugs
Green Light From FDA is Only Half the Battle
From September 2005 to February 2006, the Food and Drug Administration (FDA) approved six, first-ever generic versions of popular brand-name drugs widely used by older Americans. They are:
| Brand Name | Manufacturer | Generic Name | Treats |
| Flonase | GlaxoSmithKline | fluticasone propionate | allergies |
| Amaryl | Aventis | glimepiride | type 2 diabetes |
| Plavix | Bristol-Myers Squibb/Sanofi-Aventis | clopidogrel bisulfate | post heartattack or stroke |
| Norvasc | Pfizer | amlodipine besylate | hypertension |
| Zithromax | Pfizer | azithromycin | antibiotic |
| Altace | Wyeth | ramipril | hypertension |
This should be very good news for consumers all around. Choosing an equally effective generic over a brand-name drug typically offers the buyer a substantial cost savings. Unfortunately, only two generics on the above list have reached the market. For those two drugs, savings can be significant. Members of AARP’s MembeRx Choice, for example, could pay about $20 less for a month’s supply of the generic fluticasone propionate than for a month’s supply of Flonase and about $9.00 less for a month’s supply of glimepiride 2 mg than for a month’s supply of Amaryl 2 mg.
Meanwhile, generic versions of the remaining four drugs—Plavix, Norvasc, Zithromax and Altace—are being kept off pharmacy shelves by patent disputes between the brand-name and generic manufacturers. In the case of Bristol-Myers Squibb’s Plavix, an antiplatelet, what began as a dispute with the generic manufacturer over patent infringement has become a proposed settlement that will keep the generic version off the market until 2011. Plavix racked up huge sales in 2005—$3.8 billion in the U.S. alone, with worldwide sales of nearly $6 billion.
The entry of generic drugs to the marketplace is also slowed by the FDA approval process. The FDA’s median time for approving a generic during 2004 and 2005 was about 16 months. While that is a sharp decline from the 28 months needed in 1995, the "backlog at the Office of Generic Drugs continues to grow," said Kathleen Jager, president and chief executive officer of the Generic Pharmaceutical Association (GPhA), who estimated that more than 800 applications are awaiting action by the FDA.
Consumers pay a high cost for these delays. The GPhA has said that a 1 percent increase in the use of generic medicines nationwide—which now account for 53 percent of total prescriptions—would save $4 billion each year.
AARP Rx Watchdog will continue to update the list of new generics and report on the market status of newly approved first-time generics.
