Generic Approved for Generic Prescription Plan B

Generic Plan B

Emergency contraceptive Plan B (Levonorgestrel) was first approved in 1999. The drug has been manufactured by Duramed Pharmaceuticals Inc., of Cincinnati. Yesterday, the U.S. FDA approved the first generic version of Plan B.

From 1999 until 2006, Plan B was available only by prescription. In 2006, it was approved for nonprescription use for women ages 18 and older. Plan B has remained available as a prescription-only product for women ages 17 and under.


The generic version of the emergency contraceptive Plan B, made by Watson Laboratories Inc., based in Corona, Calif., will only be available by prescription and only for women ages 17 and under.

On August 24, 2009, the marketing exclusivity held by Duramed for the nonprescription use of Plan B will expire. At that point, the generic levorgestrel product can be approved for nonprescription use in women 18 and older.

Levonorgestrel can prevent pregnancy after unprotected intercourse or a known or suspected contraceptive failure. It is not effective in terminating an existing pregnancy and does not protect against sexually transmitted diseases, including HIV infection.

FDA News