What is Paxil?
Paxil (paroxetine) is an antidepressant that belongs to the group of drugs called selective serotonin reuptake inhibitors (SSRIs). Paxil was approved in the United States in 1992 and initially sold by SmithKline Beecham (GlaxoSmithKline now). Paroxetine affects chemicals in the brain that may be unbalanced in people with depression, anxiety, or other disorders. Paxil is used to treat depression, including major depressive disorder. Paxil is also used to treat panic disorder, obsessive-compulsive disorder (OCD), anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).
When SmithKline Beecham launched Paxil in 1993, it was lagging behind in the antidepressant market. At this time Pfizer's Zoloft and Eli Lilly's Prozac were leading the market. In 2000 Paxil became number one in the U.S. selective serotonin reuptake inhibitor market for new retail prescriptions.
The success of Paxil was possible due to the combination of two strategies: patent protection and disease awareness. Protection of patency was done through serial patent submission tactic. Where as disease marketing was a combination of physician, public relation and direct to consumer campaign meant to inform target audience about the disease and to let them know that Paxil alone had been approved to treat it.
Let's review these strategies in more details
In 1986, SmithKline Beecham filed for a patent of the basic drug (paroxetine hydrochloride hemihydrate). The FDA approved Paxil NDA in 1992 and the patent was listed in the Orange Book. Generics wanted to enter the market. The first move was by Apotex in 1998, filing a Paragraph IV certification claiming a non-infringing version of paroxetine. The response of SmithKline Beecham was very clever. The company obtained four other patents between 1998-2000. The new patents were for a mix of paroxetine with liquid and the anhydrous version, and paroxetine methanosulfate.
In 1999 Paxil achieved $2 billion sales which encouraged three other generic companies to file Paragraph IV certifications in 2000 claiming a non-infringing version of paroxetine.
Through "serial patent submission tactic" SmithKline Beecham was able to keep the generics away as the each additional patent listed in the Orange Book triggered the start of a new 30-month delay of generic entry.
In 2001, Paxil had become the seventh most profitable brand in America.
In parallel to the serial patent submission tactics, SmithKline Beecham found an under-diagnosed and under-treated indication; social anxiety disorder (SAD). People suffering from SAD have fear of social or performance situations which imply exposure to unfamiliar people. In 1998, the company applied for FDA approval to market Paxil for SAD.
The strategy was to educate target audience about SAD and promote Paxil as the only medication that treats this indication.
SmithKline Beecham funded a public relation campaign to spread the awareness about SAD. The campaign targeted consumers and physicians with an objective to encourage the diagnosis and treatment of SAD. The campaign did not explicitly mention Paxil or SmithKline Beecham.
The slogan of the campaign "Imagine Being Allergic to People" was added to to all ads.
In may 1999, SmithKline Beecham received FDA approval for the treatment of SAD. The company increased its spending on physician-targeted ads by $1 million, according to Medical Marketing and Media. The company changed the copy in medical journals from ‘‘Paxil means peace . . . in depression, panic disorder, and OCD’’ to ‘‘Show them they can . . . the first and only approved treatment for social anxiety disorder.’’ (find the ads on the internet videos and print ads)
In September 1999 SmithKline Beecham launched its first Paxil direct-to-consumer ads, a TV and print campaign
PR News reported that, as a result of the campaign to advertise social anxiety disorder, media references to the condition climbed to more than 1 billion articles, up from 50 in 1997 and 1998, with 96 percent conveying the information that Paxil was the only FDA-approved treatment then available.
what was the results? Paxil scored third among advertised prescription drugs in unaided recall, behind Viagra and Claritin 7 months after the campaign had been running, according to Medical Marketing and Media (hyperlink of the refernce)
In December 1998, prior to the campaign, Paxil's market share was 9.3% of 6.7 million prescriptions. From June to October 1999, as the campaign ran, Paxil's market share grew to 11.5% and contributed to the increase of the entire market to 7.2 million prescription.
Closing the FDA's Orange Book, 2001. ↗
Disorders Made to Order, Mother Jones, 2002. ↗