Hikma's Opana ER Generic Faces Final Sales Discontinuation Due to FDA Abuse Deterrent Regulation
Regulatory Risks Materialize, Leading to Sales Discontinuation
According to the U.S. Food and Drug Administration (FDA)'s Orange Book, Hikma Pharmaceuticals' generic version of oxymorphone hydrochloride extended-release tablets, a narcotic analgesic, has had its approval status changed to 'Discontinued.' This drug, with ANDA number 200822, received final generic approval from the FDA on July 15, 2013. The move comes as opioid analgesic abuse has become a serious social problem in the United States, leading regulatory authorities to continuously strengthen monitoring of extended-release formulations.
The Ripple Effect of the Original Drug's Withdrawal
The decision to discontinue this generic product stems from the withdrawal of the original reference listed drug, Opana ER, by Endo Pharmaceuticals. In June 2017, the FDA held an advisory committee (AdComm) meeting and determined that Opana ER's abuse-deterrent formulation technology was not sufficient to prevent actual abuse. The committee voted 18 to 8 to recommend market withdrawal. Subsequently, Endo announced a voluntary market withdrawal in July 2017, creating an environment in which generic manufacturers were also forced to halt commercial sales.
Hikma's Portfolio Diversification Strategy
Hikma Pharmaceuticals had initially acquired a portfolio, including the Opana ER generic, through the acquisition of Roxane Laboratories. The Roxane acquisition deal was valued at approximately $2.1 billion (USD), including $647 million in cash and the issuance of 40 million new shares, based on the adjusted final contract terms. By reducing its reliance on high-risk opioid products and rapidly diversifying its portfolio into injectables and generic pharmaceuticals, Hikma has successfully absorbed the regulatory impact, recording a solid annual revenue of $3.127 billion in 2024.
The Rise of Non-Opioid Pain Treatment Alternatives
This sales discontinuation case clearly demonstrates the global pharmaceutical and biotechnology market's shift away from mu-opioid receptor agonists towards non-opioid pain treatments. The U.S. opioid market is projected to reach $7.64 billion (USD) by 2026, but regulatory barriers continue to increase due to addiction and abuse concerns. In contrast, the non-opioid pain treatment market is expected to grow at a steady annual rate, reaching approximately $36.87 billion (USD) by 2034, suggesting that competition for alternatives will accelerate in the future.
As the opioid analgesic market shrinks, Hikma Pharmaceuticals' generic approval (ANDA 200822) for oxymorphone extended-release tablets being discontinued highlights the tangible impact of the FDA's policy of withdrawing abuse-prone drugs on the generic industry. Following the withdrawal of Endo Pharmaceuticals' original drug, Opana ER, in 2017 due to an advisory committee (AdComm) recommendation, generic manufacturers have also faced strict regulatory risks. This indicates that, despite the U.S. opioid market maintaining a size of $7.64 billion by 2026, regulatory pressure is making it difficult for new entrants and leading to the withdrawal of existing products. As a result, the capital market is seeing an increase in risk for companies with opioid portfolios, while investment funds are rapidly shifting towards companies developing non-opioid pain treatment pipelines, which are expected to grow to $36.87 billion by 2034, creating a long-term ripple effect.
Source: openFDA (api_fda)
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=ANDA200822