Sitagliptin phosphate manufacturers

About sitagliptin phosphate

Sitagliptin phosphate manufacturers include the originator Merck (MSD), which sells Januvia, and many generic producers in Europe, India and China, with US generics allowed under settlements from May 2026. Sitagliptin is an oral DPP-4 inhibitor (gliptin) for type 2 diabetes. It increases insulin release after meals with a low risk of low blood sugar. Pharmaceutical companies can source sitagliptin tablets, combinations with metformin and API through out-licensing, supply or technology transfer. Dossiers are available in US ANDA and EU CTD formats.

Sitagliptin phosphate key facts

Sitagliptin phosphate manufacturers and licensing history

Merck developed sitagliptin as the first DPP-4 inhibitor, approved by the FDA in October 2006 as Januvia. Janumet, combining sitagliptin with metformin, followed in 2007. Januvia became one of the world's best-selling diabetes medicines.

In the EU, sitagliptin generics have been available since 2022. In the US, Merck settled with more than 20 generic companies, allowing them to launch Januvia and Janumet generics from May 2026 and Janumet XR generics from July 2026. Viatris chose to litigate instead, but courts upheld Merck's salt patent, which expires on 24 November 2026, with paediatric exclusivity to 24 May 2027.

Zituvio, a sitagliptin free base product from Zydus, was approved in the US through a different pathway. Buyers should confirm the salt form (phosphate or free base), GMP status, a DMF or CEP and patent position before choosing a dossier partner.

Sitagliptin phosphate dosage forms and dossier types

Sitagliptin is approved as 25, 50 and 100 mg tablets and in fixed-dose combinations with metformin.

Sitagliptin phosphate regulatory and patent status

The FDA approved sitagliptin in October 2006. In the US, settlements allowed generic Januvia and Janumet from May 2026 for settling companies, while Merck's salt patent runs to 24 November 2026 and paediatric exclusivity to 24 May 2027. EU generics have been available since 2022. The Janumet co-formulation patent runs to 2029, with paediatric exclusivity to July 2029.

Sitagliptin phosphate mechanism of action and therapeutic use

Sitagliptin blocks DPP-4, the enzyme that breaks down incretin hormones such as GLP-1. Higher incretin levels increase insulin release and reduce glucagon after meals, lowering blood sugar. Sitagliptin is taken once daily for type 2 diabetes, alone or with metformin and other drugs. It does not cause weight gain and rarely causes low blood sugar on its own.

Sitagliptin phosphate licensing and sourcing

Sitagliptin suppliers and licensing partners typically offer dossier out-licensing, finished-product supply or technology transfer. Buyers usually compare GMP status (EU GMP, US FDA or WHO GMP), salt form, dossier readiness and territory availability. Current offers and supplier contacts are listed among the sitagliptin phosphate manufacturers on Pipelinepharma.

Frequently asked questions about sitagliptin phosphate

Who are the main sitagliptin manufacturers? Merck (MSD) is the originator and sells Januvia and Janumet. Many generic companies in Europe, India and China make sitagliptin.

When could generic sitagliptin launch in the US? Merck's settlements allowed generic Januvia and Janumet from May 2026 for more than 20 companies. Others must wait for the salt patent and paediatric exclusivity, which run to May 2027.

Is a sitagliptin EU CTD dossier available for licensing? Yes. Sitagliptin and sitagliptin/metformin dossiers in EU CTD format are widely available, and EU generics have been sold since 2022.

What forms and strengths of sitagliptin are available? Sitagliptin is available as 25, 50 and 100 mg tablets and in combination tablets with metformin.

What is the difference between sitagliptin phosphate and sitagliptin free base? Januvia contains sitagliptin phosphate. Zituvio contains sitagliptin free base and was approved through a separate US pathway.