What's the Generic for Januvia?

October 10, 2025 •

3 min read

As of late 2025, there is no generic equivalent of the brand-name drug Januvia (sitagliptin) available in the U.S. that is interchangeable with the original. The active ingredient in Januvia is sitagliptin, which has a key patent that expires in 2026, though a different generic sitagliptin formulation (Zituvio) is available.

Quick Summary

Januvia, a brand-name medication for type 2 diabetes with the active ingredient sitagliptin, does not yet have an interchangeable generic equivalent in the U.S. due to patent protection. While the generic sitagliptin product Zituvio is available, it is not considered interchangeable with Januvia.

Key Points

Generic Name: The generic name for Januvia is sitagliptin.
No Interchangeable Generic Yet: As of late 2025, there is no generic equivalent of Januvia considered therapeutically interchangeable in the U.S..
Patent Protection: Januvia's patent is expected to expire in 2026, after which interchangeable generics may become available.
Zituvio: An Alternative Sitagliptin: The generic sitagliptin product Zituvio is FDA-approved but is not interchangeable with Januvia due to a different salt form.
Drug Class: Both Januvia and Zituvio are DPP-4 inhibitors used to treat type 2 diabetes.
Cost Comparison: Generic sitagliptin (Zituvio) is available at a significantly lower cash price than brand-name Januvia.

Understanding Brand and Generic Medications

When a pharmaceutical company develops a new drug, it is protected by patents for a period of time, allowing them to market it exclusively under a brand name. Januvia, manufactured by Merck, is one such brand-name drug. Once these patents expire, other companies can produce and sell generic versions of the drug. A generic drug contains the same active ingredient, strength, and dosage form as the brand-name version and is considered bioequivalent by the FDA, meaning it works the same way in the body. The main difference for patients is usually a significantly lower cost.

The Active Ingredient in Januvia

The generic name for Januvia is sitagliptin. It is a member of the dipeptidyl peptidase-4 (DPP-4) inhibitor class of drugs, used to help lower blood sugar levels in adults with type 2 diabetes. It works by increasing the levels of incretin hormones, which stimulate the release of insulin and decrease the production of glucose by the liver when blood sugar is high.

Why is there no interchangeable generic for Januvia yet?

The primary reason for the lack of an interchangeable generic for Januvia in the U.S. is related to patent exclusivity. The key patent covering the sitagliptin dihydrogen phosphate salt used in Januvia is set to expire on November 24, 2026, with pediatric exclusivity extending until May 24, 2027. While some manufacturers have made agreements with Merck to potentially launch generic versions as early as May 2026, no interchangeable product is currently on the market. This differs from many brand-name medications where a generic becomes widely available immediately after the patent expires.

Introducing Zituvio: A generic sitagliptin, but not a generic Januvia

While a generic version of Januvia is not yet available, a separate generic sitagliptin product, Zituvio, received FDA approval in 2023. This is an important distinction, as Zituvio is not considered a therapeutically interchangeable generic for Januvia, though they both contain sitagliptin.

Key Differences Between Januvia and Zituvio

Salt form: Januvia contains sitagliptin phosphate, while Zituvio contains the free base form of sitagliptin.
Manufacturer: Januvia is made by Merck, and Zituvio is made by Zydus Pharmaceuticals.
Interchangeability: Because of the different salt forms, Zituvio is not considered an interchangeable generic for Januvia. A healthcare provider must write a specific prescription for Zituvio.
Availability: While Januvia is widely available, Zituvio is currently available exclusively through select pharmacies, such as Marley Drug, which offers it at a significantly lower cash price.

Alternatives to Januvia

If cost is a major concern or a patient needs to consider alternatives, other medications are available to treat type 2 diabetes. These may come from different drug classes and have varying side effect profiles and mechanisms of action. It is crucial to discuss any medication changes with a healthcare provider.

Comparison of Diabetes Medications


Feature	Januvia (Sitagliptin)	Metformin	SGLT-2 Inhibitors	GLP-1 Agonists	Zituvio (Sitagliptin)
Drug Class	DPP-4 Inhibitor	Biguanide	SGLT-2 Inhibitor	GLP-1 Agonist	DPP-4 Inhibitor
Mechanism	Increases insulin release and decreases glucose production	Decreases glucose production in the liver; increases insulin sensitivity	Increases glucose excretion in urine	Increases insulin secretion; decreases glucose production; slows gastric emptying	Increases insulin release and decreases glucose production
Delivery	Oral tablet	Oral tablet	Oral tablet	Injectable (some oral)	Oral tablet
Cost	Brand-name; high cost	Generic; low cost	Varies; some brand-name only	High cost; brand-name	Generic; significantly lower cash price
Side Effects	Headache, stuffy/runny nose	Diarrhea, nausea	Yeast infections, frequent urination	Nausea, vomiting, diarrhea	Headache, stuffy/runny nose

Conclusion: Finding the Right Medication for You

The active ingredient for Januvia is sitagliptin, but there is no generic version considered interchangeable with brand-name Januvia in the U.S. market as of late 2025. While a key patent is set to expire in 2026, leading to the potential availability of interchangeable generics in the future, patients have immediate options. The FDA-approved generic sitagliptin product, Zituvio, is an alternative, though not interchangeable, and may offer significant cost savings. For many patients, the decision between brand-name Januvia, generic sitagliptin like Zituvio, or other diabetes medications depends on cost, availability, and individual health needs, which should always be discussed with a healthcare provider.

Authoritative Outbound Link

For more detailed information on Januvia and other FDA-approved drugs, visit the official website of the U.S. Food and Drug Administration (FDA).

Frequently Asked Questions

Sitagliptin is the active ingredient in Januvia, but as of late 2025, there is no generic version available in the U.S. that is considered therapeutically interchangeable with the brand-name drug.

Zituvio is a generic sitagliptin product that uses a different salt form than Januvia. Because of this difference, Zituvio is not considered therapeutically interchangeable with Januvia, even though they share the same active ingredient.

The key difference is the salt form of sitagliptin. Januvia contains sitagliptin phosphate, while Zituvio contains the free base form of sitagliptin. This difference prevents them from being considered interchangeable by the FDA.

A key patent for Januvia expires in November 2026, with some potential for earlier generic launches based on manufacturer agreements. After this date, an interchangeable generic equivalent may become available in the U.S. market.

Yes, generic drugs must be proven bioequivalent to their brand-name counterparts, meaning they contain the same active ingredients and work in the same way. The FDA ensures generic drugs meet the same quality and safety standards.

You can switch from Januvia to Zituvio, but you will need a new prescription from your healthcare provider. Your doctor will need to specify Zituvio since it is not an interchangeable substitute for Januvia.

Besides generic sitagliptin (Zituvio), other diabetes medications include metformin, other DPP-4 inhibitors (such as Onglyza), SGLT-2 inhibitors, and GLP-1 agonists. Your healthcare provider can help determine the best alternative for your needs.