The Fact
Prozac and Sarafem used the same active drug: fluoxetine. In July 2000, Eli Lilly received approval to market fluoxetine for premenstrual dysphoric disorder (PMDD) under the trade name Sarafem. Lilly’s composition-of-matter patent on fluoxetine expired in 2001. A separate MIT-licensed patent covered use of fluoxetine for certain premenstrual conditions, and royalties on Sarafem continued under that use patent after the original fluoxetine composition patent expired.
What This Means
A drug already sold as Prozac was also sold under a different brand name for a female-specific diagnosis. The molecule did not become a different drug when the name on the package changed.
The documented chronology lets us separate three things people often blur together: the drug itself, the diagnosis it is prescribed for, and the patents covering the molecule or a particular use of it.
Sources
- Indevus Pharmaceuticals SEC Form 10-K: July 2000 PMDD approval; fluoxetine composition patent expired July 2001; separate use-patent royalties. https://www.sec.gov/Archives/edgar/data/854222/000092701602006055/d10k.htm
- Eli Lilly SEC filing, 2001: generic fluoxetine entered the U.S. market in August 2001; Sarafem launched for PMDD. https://www.sec.gov/Archives/edgar/data/59478/000102140801504899/d10q.htm