AndroGel (testosterone gel)
Company: AbbVie
Condition: Low testosterone
2013 sales: $1.03 billion (includes 1% and 1.62% strengths)
U.S. patent expiration date: AndroGel 1% expected to face generic competition in early 2015

For a while, AbbVie ($ABBV) was riding high on the success of its testosterone supplement AndroGel. Sales of the drug--now available in 1% and 1.62% concentrations--grew to $1.15 billion in 2012, and researchers expect the market for "Low T" supplements to grow to $5 billion by 2017. AbbVie spent more than $45 million promoting AndroGel in the first half of 2013, catapulting the franchise to its second best-selling product line and putting it in the hands of more men with clinically low testosterone levels.

But then, regulators came knocking. In January, the FDA announced that it would investigate the safety of Low-T drugs in light of troubling study data that showed an increased risk of death from heart attack or stroke in men with or without a history of heart disease. In June, the agency decided that drug labels for testosterone supplements must include a general warning about the risk of blood clots, dealing another blow to AbbVie's big-selling product. The regulatory backlash reached a head in September, when an FDA advisory panel recommended limiting the use of testosterone replacement therapies for safety reasons.

AndroGel sales suffered as a result, dropping 5% in the first half of 2014--a downward spiral that may continue, especially when generic competitors hit the market.

Meanwhile, the company continues to fight for patent rights for its testosterone gel in two separate court cases, alleging that two generic competitors infringe on its patents and should be removed from the market. AbbVie also faces litigation claiming that the drugmaker spent $80 million on an advertising campaign promoting testosterone supplements as a remedy against typical signs of aging such as fatigue and low sex drive.

On a separate front, AbbVie is warding off an FTC suit that accuses it and fellow drugmaker Teva Pharmaceutical Industries ($TEVA) of keeping a generic version of AndroGel from consumers. The agency's action is the first since last year's Supreme Court case which claimed that pay-for-delay deals are not inherently illegal, a potential setback for drugmakers trying to ward off generic competitors.

The company expects sales of its 1% formula to be hit by generic competition in early 2015, AbbVie said in an SEC filing. Meanwhile, it's fighting patent suits over the 1.62% formulation, hoping to keep its lock on that market past 2020.

For more:
Put a lid on 'Low-T' drug use, FDA panel advises, threatening AbbVie, Lilly meds
FTC takes after AbbVie, Teva for pay-for-delay deal on AndroGel
FDA moves for more warnings on testosterone products
Abbott, AbbVie get to defend testosterone lawsuits on their own turf
FDA investigating heart and stroke risks of using testosterone to treat 'low T'

-- Emily Wasserman (email | Twitter)