Praluent (alirocumab), a PCSK9 inhibitor used to lower LDL-C (bad) cholesterol, has been at the center of several market controversies, leading to confusion about its availability. The perception that Praluent was pulled from the market stems from two distinct situations: a dramatic U.S. patent lawsuit in 2017 and a more recent, targeted withdrawal from certain international regions in 2025.
The U.S. Patent Dispute with Amgen
In a landmark legal battle that began in 2014, Amgen, the manufacturer of competing PCSK9 inhibitor Repatha (evolocumab), sued Praluent's makers, Sanofi and Regeneron Pharmaceuticals. The core of the dispute was Amgen's claim that Praluent infringed on its patents for cholesterol-fighting antibodies.
The January 2017 Court Order
After a lengthy legal process, a Delaware jury initially sided with Amgen in March 2016, finding their patents valid and infringed by Praluent. This led to a U.S. District Court judge issuing a permanent injunction in January 2017, ordering Sanofi and Regeneron to withdraw Praluent from the U.S. market within 30 days. Amgen argued that continued sales of Praluent would cause them “irreparable harm” and sought to maintain market exclusivity for its drug, Repatha.
The Appeals Process and Outcome
Following the court order, Sanofi and Regeneron immediately vowed to appeal the decision. Just a month later, in February 2017, the U.S. Court of Appeals for the Federal Circuit granted a stay, or suspension, of the permanent injunction. This crucial ruling allowed Praluent to remain on the U.S. market while the appeal was being heard.
The legal fight continued for several years, with both companies challenging court decisions. The saga concluded with a settlement in 2019, which effectively resolved the U.S. patent dispute and allowed both drugs to remain on the market.
Recent Withdrawal from International Markets
While the U.S. market battle was a prominent legal issue, a more recent decision led to Praluent's withdrawal from certain international markets. In August 2025, Sanofi announced it would cease supplying Praluent in China and other specific regions.
This decision was driven by several factors:
- Global Supply Chain Issues: Sanofi cited ongoing challenges in the global supply chain for active pharmaceutical ingredients (APIs) as a reason for its limited availability.
- Strategic Portfolio Optimization: The company also made a strategic decision to focus on other high-potential areas of its pipeline, pivoting away from its cardiovascular portfolio in some markets.
- Increased Competition in China: In China, the decision was partly influenced by the growing competition from locally developed PCSK9 inhibitors that had been added to the national medical reimbursement list.
Market Dynamics and Competition
Beyond legal and logistical issues, the competition and cost of PCSK9 inhibitors played a significant role in their market performance. Both Praluent and Repatha entered the market with high price tags, leading to pushback from health insurers and pharmacy benefit managers.
Despite their effectiveness, the high cost made access difficult for many patients, with payers often requiring stringent pre-authorization processes. This market resistance limited initial sales and contributed to the intense competition between Amgen, Sanofi, and Regeneron.
Comparing Praluent and Repatha
To understand the competitive landscape, it is helpful to compare Praluent with its main rival, Repatha.
| Feature | Praluent (alirocumab) | Repatha (evolocumab) |
|---|---|---|
| Manufacturers | Sanofi and Regeneron | Amgen |
| U.S. Market Status | Continues to be available | Continues to be available |
| Mechanism of Action | PCSK9 inhibitor | PCSK9 inhibitor |
| LDL-C Reduction | Very similar at comparable doses | Very similar at comparable doses |
| Dosage Options | Offers two doses (75mg and 150mg) | Offers one main dose (140mg) |
| Initial Cost | Initially high (>$14k/year) | Initially high (>$14k/year) |
| U.S. Patent History | Accused of infringing on Amgen's patents; legal dispute settled | Filed patent infringement suit against Praluent makers; dispute settled |
| Recent Withdrawals | Withdrawn from China and other specific markets in 2025 due to supply and strategy | No major recent withdrawals reported |
Conclusion
In summary, the reason why was Praluent pulled from the market is more nuanced than a simple drug recall. The initial U.S. market removal order in 2017 was a result of a patent lawsuit with Amgen, but it was successfully appealed and never permanently enforced. The drug continues to be available in the U.S.. More recently, specific market withdrawals, such as in China in 2025, occurred for unrelated reasons, including global supply limitations and a strategic shift by the manufacturer, Sanofi. Patients should always consult their healthcare provider regarding their specific treatment plan and access to medication.
