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Is there a generic version of Tyrvaya?

4 min read

Approximately 16 million people in the U.S. have been diagnosed with dry eye disease [1.8.4]. For those seeking affordable treatment, a common question is: Is there a generic version of Tyrvaya? As of September 2025, the answer is no [1.2.2].

Quick Summary

Currently, no generic equivalent for Tyrvaya (varenicline) nasal spray is on the market [1.2.1, 1.2.2]. This article explores Tyrvaya's patent protection, its unique mechanism for treating dry eye, and compares it to other available therapies.

Key Points

  • No Generic Available: As of September 2025, there is no generic version of Tyrvaya nasal spray on the market [1.2.2].

  • Patent Expiration: Tyrvaya's patents are currently set to expire in October 2035, delaying the potential launch of a generic [1.3.1, 1.3.3].

  • Active Ingredient: The active ingredient is varenicline, but the generic tablets for smoking cessation are not a substitute for the dry eye nasal spray [1.7.2].

  • Unique Mechanism: Tyrvaya is a nasal spray that stimulates a nerve in the nose to increase the body's own tear production [1.4.1].

  • Treatment Alternatives: Other prescription options for dry eye include Restasis (which has a generic), Xiidra, Cequa, and Miebo [1.6.2, 1.6.5].

  • Common Side Effects: The most frequent side effect of Tyrvaya is sneezing, followed by cough and throat or nose irritation [1.9.1, 1.2.6].

In This Article

Understanding Tyrvaya and its Role in Dry Eye Treatment

Tyrvaya, with the active ingredient varenicline, is a novel prescription medication approved by the FDA on October 15, 2021, for the signs and symptoms of dry eye disease [1.9.2]. It stands out as the first and only treatment available as a nasal spray rather than traditional eye drops [1.9.5]. This unique delivery method avoids direct contact with an already irritated ocular surface [1.4.1]. The medication is a cholinergic agonist that is believed to work by stimulating the trigeminal parasympathetic pathway in the nasal cavity. This activation prompts the glands and cells around the eyes to increase the production of the natural tear film, which is composed of water, oil, and mucin [1.4.2, 1.4.3].

Dry eye disease is a common and often chronic condition where an individual's tears do not provide adequate lubrication for their eyes [1.9.1]. This can be due to insufficient tear production or poor quality of tears that evaporate too quickly [1.2.6]. Symptoms frequently include stinging, burning, redness, and blurred vision [1.2.6]. Tyrvaya addresses this by helping the body produce more of its own natural tears [1.4.3].

Is there a generic version of Tyrvaya?

As of September 2025, there is no generic version of Tyrvaya (varenicline nasal spray) available in the United States [1.2.2, 1.2.3]. Tyrvaya is only sold as a brand-name medication. While the active ingredient, varenicline, is available as a generic in tablet form for smoking cessation (formerly the brand name Chantix), this formulation is not a substitute for the Tyrvaya nasal spray used for dry eye disease [1.7.2, 1.7.4, 1.3.4]. The delivery method and dosage are specific to the condition being treated.

Why No Generic and When Can We Expect One?

The absence of a generic is due to patent protection, which grants the manufacturer, Viatris (formerly Oyster Point Pharma), exclusive rights to sell the drug [1.2.3, 1.3.2]. This period of exclusivity allows the company to recoup the costs associated with research, development, and clinical trials [1.2.4].

According to records, Tyrvaya is protected by multiple patents that are set to expire in October 2035 [1.3.1, 1.3.3]. While a generic drug manufacturer submitted an Abbreviated New Drug Application (ANDA) in April 2023 to challenge these patents, the outcome of such legal challenges is uncertain [1.3.5, 1.3.2]. Therefore, a generic version is not expected to launch until after the patents expire in 2035, unless the patent litigation rules in favor of the generic manufacturer sooner.

Tyrvaya Alternatives and Cost Comparison

Given that Tyrvaya is a brand-name-only drug, its cost can be a significant factor for patients. The average retail price for a 30-day supply (two bottles) can be around $811, though coupons and savings programs may lower the out-of-pocket cost [1.5.2, 1.5.1]. For those seeking other options, several alternatives exist for managing dry eye disease, ranging from over-the-counter (OTC) products to other prescription medications.

Over-the-Counter (OTC) Options:

  • Artificial Tears: These are typically the first line of treatment and come in liquid, gel, or ointment forms. Brands include Refresh, Systane, and TheraTears [1.6.2, 1.6.4].
  • Lipid-Based Drops: For evaporative dry eye, drops containing oils can help stabilize the tear film [1.6.2].

Prescription Alternatives:

  • Cyclosporine (Restasis, Cequa, Vevye): These are eye drops that work by reducing inflammation to help increase natural tear production. A generic version of Restasis is available [1.6.3, 1.6.5].
  • Lifitegrast (Xiidra): This eye drop also targets inflammation by blocking specific proteins on the eye's surface [1.6.2].
  • Perfluorohexyloctane (Miebo): This is a newer eye drop designed to reduce tear evaporation by creating a protective layer [1.6.3].

Comparison Table of Prescription Dry Eye Treatments

Medication Active Ingredient Administration Mechanism of Action Generic Available (as of Sep 2025)?
Tyrvaya Varenicline Nasal Spray Stimulates trigeminal nerve to increase tear production [1.4.1] No [1.2.2]
Restasis Cyclosporine Eye Drops Reduces inflammation to increase tear production [1.6.3] Yes [1.6.5]
Xiidra Lifitegrast Eye Drops Blocks proteins involved in inflammation [1.6.2] No
Cequa Cyclosporine Eye Drops Reduces inflammation to increase tear production [1.6.3] No
Miebo Perfluorohexyloctane Eye Drops Reduces tear evaporation by forming a protective layer [1.6.3] No

Potential Side Effects of Tyrvaya

The most common side effect reported in clinical trials for Tyrvaya was sneezing, experienced by 82% of patients [1.9.1]. Other common side effects include cough, and nose and throat irritation [1.2.6]. These side effects are generally mild. No serious side effects were reported in the clinical trials [1.2.6]. Patients are advised not to repeat a dose if they sneeze immediately after administration [1.2.6].

Conclusion

For the millions of people dealing with dry eye disease, Tyrvaya offers a unique and effective treatment option delivered via a nasal spray. However, as of late 2025, it is only available as a brand-name medication, and a lower-cost generic version is not expected until its patents expire around 2035 [1.3.1]. Patients concerned about the cost of Tyrvaya have several alternatives, including OTC artificial tears and other prescription medications like Restasis (which has a generic option), Xiidra, and Cequa. Consulting with an eye care professional is the best way to determine the most appropriate and cost-effective treatment plan for individual needs.

For more information from a regulatory body, you can visit the FDA's page on drug information.

Frequently Asked Questions

No, as of September 2025, Tyrvaya is only available as a brand-name medication. There is no generic equivalent currently on the market [1.2.2, 1.2.3].

A generic version of Tyrvaya is not expected until after its patent protections expire, which is currently scheduled for October 2035 [1.3.1, 1.3.3].

Yes, Tyrvaya contains the active ingredient varenicline, which was also in Chantix (a smoking cessation pill) [1.7.2]. However, the formulations are different; Tyrvaya is a nasal spray specifically for dry eye, and the generic varenicline tablets for smoking cessation cannot be used for this purpose [1.7.4].

Tyrvaya is a nasal spray that stimulates the trigeminal parasympathetic pathway. This nerve activation signals the body to increase its natural production of tear film, which helps to lubricate the eyes [1.4.1, 1.4.3].

The most common side effect is sneezing, which occurred in about 82% of patients in clinical trials. Other reported side effects include coughing and irritation in the nose and throat [1.9.1, 1.2.6].

Alternatives include over-the-counter artificial tears and other prescription treatments like Restasis (cyclosporine), Xiidra (lifitegrast), Cequa (cyclosporine), and Miebo (perfluorohexyloctane). A generic version of Restasis is also available [1.6.2, 1.6.3, 1.6.5].

The retail price for a 30-day supply of Tyrvaya can be over $800. However, the manufacturer offers savings programs, and prices may vary depending on insurance coverage and pharmacy coupons [1.5.2, 1.5.1].

References

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Medical Disclaimer

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