Who Owns Accutane?

Accutane was developed by Roche in the late 1970s through extensive research into retinoid therapy for treating severe acne. The compound isotretinoin, a vitamin A derivative, was first synthesized in 1955, but its potential as an acne treatment wasn't discovered until the 1970s. Dr. Gary Peck at the National Institutes of Health observed that isotretinoin dramatically reduced sebaceous gland size and oil production, leading to Roche's development of the drug specifically for severe recalcitrant acne that didn't respond to conventional antibiotics or topical treatments.

The FDA granted approval for Accutane in 1982 as a treatment for severe nodular acne, making it the first oral medication specifically designed to address the underlying causes of severe acne rather than just treating symptoms. The initial market reception was cautious due to the drug's serious potential side effects, including birth defects if taken during pregnancy. Despite these concerns, Accutane quickly gained recognition among dermatologists for its unprecedented efficacy in clearing severe cystic acne that previously had no effective treatments. Within five years of its launch, Accutane had become a standard part of dermatological practice for treatment-resistant acne cases.

In 1988, responding to increasing reports of birth defects associated with Accutane use during pregnancy, the FDA and Roche implemented the Pregnancy Prevention Program (PPP), requiring pregnancy tests and contraception for female patients of reproductive potential. This evolved in 2006 into the more comprehensive iPLEDGE program, requiring registration of prescribers, patients, and pharmacies. The iPLEDGE program represented one of the most stringent risk management programs ever implemented for a prescription medication, reflecting both the potency of the drug and regulatory concerns about its teratogenic effects.

Throughout the 1990s and early 2000s, Accutane became Roche's leading dermatological product, with annual sales reaching approximately $700 million at their peak. However, the medication also faced mounting legal challenges, with thousands of lawsuits alleging links between Accutane use and inflammatory bowel disease, depression, and suicide. These legal challenges, combined with decreasing market share due to generic competition after patent expiration in 2002, ultimately led to Roche's decision to discontinue the brand-name Accutane in the United States in June 2009. By then, generic versions had captured over 99% of the isotretinoin market in the U.S.

Despite the brand's discontinuation in the American market, Roche continues to sell isotretinoin under the brand name Roaccutane in many international markets. The core formulation has remained largely unchanged since its introduction, though various delivery technologies have been developed to enhance absorption. From 2009 to 2026, generic manufacturers have continued refining their isotretinoin products, with innovations like Absorica (developed by Sun Pharma) providing enhanced bioavailability when taken with or without food, a significant improvement over the original formulation. In 2023, the FDA relaxed some requirements for the iPLEDGE program following supply chain and access issues during the COVID-19 pandemic, with these changes becoming fully implemented by 2026.

Through its history, Accutane revolutionized severe acne treatment, establishing isotretinoin as the gold standard therapy for recalcitrant nodular acne. Despite the brand's discontinuation in the United States, its scientific innovation continues to benefit patients through generic formulations, and its risk management protocols have influenced regulatory approaches to high-risk medications across the pharmaceutical industry.