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Is Esbriet Being Discontinued? The Status of Pirfenidone in 2025

4 min read

Affecting approximately 140,000 Americans, Idiopathic Pulmonary Fibrosis (IPF) is a serious lung condition [1.4.1]. A key question for patients is: Is Esbriet being discontinued? While the brand-name drug remains available, the treatment landscape has significantly changed with the introduction of generic pirfenidone [1.3.1, 1.4.3].

Quick Summary

Esbriet (pirfenidone) is not discontinued, but the approval of generic pirfenidone has expanded treatment options for Idiopathic Pulmonary Fibrosis (IPF) [1.3.1, 1.4.6]. Patients now have more affordable choices alongside the main alternative, Ofev (nintedanib).

Key Points

  • Not Discontinued: Brand-name Esbriet (pirfenidone) is not being discontinued, though one specific tablet strength (534 mg) was phased out in the past [1.2.1, 1.3.2].

  • Generic Pirfenidone is Available: The FDA has approved multiple generic versions of pirfenidone, which are considered equally safe and effective and are typically more affordable [1.4.6, 1.7.2].

  • Primary Indication: Esbriet and its generic versions are used to treat Idiopathic Pulmonary Fibrosis (IPF), a progressive lung-scarring disease [1.4.4].

  • Main Alternative: The other primary drug for IPF is Ofev (nintedanib), which has a different side-effect profile, most notably causing diarrhea [1.2.1].

  • Treatment Choice is Individual: The decision between pirfenidone and nintedanib often depends on patient tolerance to specific side effects, such as Esbriet's photosensitivity versus Ofev's gastrointestinal issues [1.5.3].

  • Cost Savings: The availability of generic pirfenidone offers significant cost savings compared to the brand-name Esbriet [1.7.4].

  • Comprehensive Care is Key: Treatment for IPF involves more than just medication, including pulmonary rehabilitation, oxygen therapy, and smoking cessation [1.6.1, 1.6.4].

In This Article

Is Esbriet Being Discontinued? A Look at the Current Market

To directly answer the question: No, brand-name Esbriet (pirfenidone) is not being discontinued [1.3.1]. It remains an FDA-approved medication for the treatment of Idiopathic Pulmonary Fibrosis (IPF) [1.2.6]. However, the conversation around its status has shifted dramatically due to a major development in the pharmaceutical market: the arrival of generic pirfenidone. The FDA first approved generic versions of pirfenidone in 2022, a move that has increased access and introduced more affordable treatment options for patients [1.4.1, 1.4.7]. While one specific dosage strength, the 534 mg tablet, was discontinued previously, this was not due to safety or efficacy concerns [1.2.1, 1.3.2]. The currently available 267 mg and 801 mg tablets are still on the market [1.2.1].

The Rise of Generic Pirfenidone: What It Means for Patients

The introduction of generic medications is a standard part of a brand-name drug's lifecycle. A generic drug is an exact copy of the active drug in a brand-name medication and is considered to be just as safe and effective [1.7.3]. Since the initial approvals, multiple pharmaceutical companies, including Sandoz, Teva, Aurobindo Pharma, and Accord Healthcare, have launched their own FDA-approved generic pirfenidone tablets [1.4.1, 1.4.4, 1.4.5, 1.4.6].

For patients, this has several key benefits:

  • Lower Cost: Generics typically cost less than their brand-name counterparts [1.7.2]. This competition can significantly reduce the financial burden of long-term treatment for a chronic disease like IPF [1.7.4].
  • Increased Access: More manufacturers producing the medication can lead to a more stable supply and broader availability through various pharmacies.
  • Insurance Coverage: Insurance providers may prefer covering the lower-cost generic version, potentially making it the more accessible option for many patients [1.7.2].

Understanding Esbriet and Its Role in IPF Treatment

Idiopathic Pulmonary Fibrosis is a chronic and progressive disease characterized by the scarring (fibrosis) of lung tissue, which makes breathing increasingly difficult [1.4.1, 1.6.3]. The cause is unknown, as implied by the term 'idiopathic' [1.3.6]. Esbriet's active ingredient, pirfenidone, is an antifibrotic agent. While its exact mechanism is not fully understood, it is believed to slow the progression of IPF by reducing the production of substances in the body that contribute to the fibrotic process [1.3.1, 1.6.2]. Studies have shown that pirfenidone can slow the decline in lung function and may prolong life for people with IPF [1.2.1]. It is typically taken as a pill three times a day with food to help minimize gastrointestinal side effects [1.5.3, 1.6.2].

Esbriet vs. Ofev: A Comparison of IPF Treatments

The other primary medication approved for IPF is Ofev (nintedanib) [1.6.1]. Both Esbriet and Ofev are considered first-line treatments that work to slow disease progression, but they do so through different mechanisms and have different side effect profiles [1.2.1]. There have been no direct head-to-head clinical trials to definitively prove one is superior, so the choice often comes down to individual patient characteristics and tolerability [1.5.2].

Feature Esbriet (pirfenidone) Ofev (nintedanib)
Mechanism Antifibrotic and anti-inflammatory properties [1.5.3] Multikinase inhibitor [1.5.4]
Dosing Three times daily with food [1.5.3] Twice daily [1.5.3]
Common Side Effects Nausea, rash, photosensitivity, fatigue, loss of appetite [1.2.1, 1.5.3] Diarrhea, nausea, abdominal pain, liver enzyme elevation [1.2.1, 1.5.3]
Key Monitoring Liver function tests, photosensitivity precautions (sunscreen) [1.3.4, 1.6.2] Liver function tests, management of diarrhea [1.5.3, 1.6.2]
Generic Availability Yes, lower-cost generic approved [1.5.4] No lower-cost generic approved [1.5.4]

Comprehensive Management of Idiopathic Pulmonary Fibrosis

Pharmacological treatment with antifibrotics like pirfenidone or nintedanib is the cornerstone of modern IPF management, but it's only one piece of a larger puzzle [1.6.1]. A holistic approach is essential for maintaining quality of life.

Key non-pharmacological interventions include:

  • Pulmonary Rehabilitation: Exercise programs and breathing techniques can improve endurance and reduce the sensation of breathlessness [1.6.4].
  • Oxygen Therapy: For patients with low blood oxygen levels (hypoxemia), supplemental oxygen can improve symptoms and support daily activities [1.6.3].
  • Symptom Management: Addressing comorbidities like gastroesophageal reflux disease (GERD) and managing chronic cough are important aspects of care [1.6.1].
  • Lifestyle Modifications: Stopping smoking is critical, as smoking can negatively affect how well Esbriet works [1.3.4, 1.6.7]. Getting recommended vaccinations for flu and pneumonia is also vital [1.6.4].

In advanced cases, lung transplantation may be an option and is the only treatment associated with prolonged survival [1.6.4].

Conclusion: The Evolving Landscape of IPF Treatment

While rumors or questions about its status may circulate, the brand-name drug Esbriet is not being discontinued. The most significant change for patients and providers is the welcome introduction of generic pirfenidone, which offers the same therapeutic benefits at a potentially lower cost [1.7.5]. This development, alongside the alternative option of Ofev, gives the IPF community more tools than ever to manage this complex disease. Treatment decisions should always be made in close consultation with a healthcare provider to weigh the benefits and risks of each option based on an individual's health profile and lifestyle [1.6.2].


For more information from the manufacturer, please visit the official Esbriet HCP site.

Frequently Asked Questions

Yes, generic pirfenidone is considered by the FDA to be as safe and effective as the original brand-name drug, Esbriet. It contains the exact same active ingredient [1.7.3].

The most common side effects include nausea, rash, stomach upset, photosensitivity (skin sensitivity to sunlight), fatigue, and loss of appetite. It's recommended to take the medication with food to reduce some of these effects [1.2.1, 1.5.3].

While both drugs slow the progression of IPF, they have different primary side effects. Esbriet is more commonly associated with photosensitivity and nausea, whereas Ofev is most known for causing diarrhea [1.2.1].

Generally, yes. If you are interested in switching to a generic version, you should speak with your doctor and insurance provider. Your insurance plan may have a preference for covering one version over the other [1.7.2].

The 534 mg strength of Esbriet was discontinued, but not for reasons related to safety or effectiveness [1.2.1, 1.3.2]. The 267 mg and 801 mg tablets remain available for proper dosing.

Yes, pirfenidone can make your skin very sensitive to sunlight (photosensitivity). Patients are advised to use sunscreen, wear protective clothing, and avoid direct sun exposure, sunlamps, and tanning beds [1.3.5].

No, there is currently no cure for IPF [1.6.3]. Esbriet does not cure the disease, but it has been shown to slow down its progression and the decline in lung function, potentially extending life expectancy [1.2.1].

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.