Drug
Who makes sitagliptin?
8 companies list sitagliptin as a human prescription drug, including under the names JANUVIA, ZITUVIO. Forms: tablet; tablet, film coated. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing sitagliptin
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Zydus Lifesciences LimitedIndia | tablet | NDA, NDA AUTHORIZED GENERICNDA211566 | 6 | 12 |
| International Medication Systems, Ltd.United States | tablet, film coated | NDANDA021995 | 6 | 3 |
| Zydus Pharmaceuticals USA Inc.India | tablet | NDA, NDA AUTHORIZED GENERICNDA211566 | 6 | 1 |
| Apotex Inc.Canada | tablet, film coated | ANDAANDA202425 | 3 | 6 |
| Teva Pharmaceutical Industries Ltd.Canada | tablet, film coated | ANDAANDA202327 | 3 | 6 |
| Golden State Medical Supply Inc.United States | tablet, film coated | ANDAANDA202425 | 3 | 1 |
| Merck Sharp & Dohme Corp. | tablet, film coated | NDANDA021995 | 3 | 0 |
| Cardinal Health 418, Inc.United States | tablet, film coated | NDANDA021995 | 2 | 34 |
Bulk ingredient listings
- Optimus Drugs Private LimitedIndia · 1 NDC
Orange Book patents
1 unexpired patent lists sitagliptin as the active ingredient, expiring between Feb 2035 and Feb 2035. Application holder: ZYDUS LIFESCIENCES GLOBAL FZE.
Enquiry
Common questions
- Who makes sitagliptin?
- 8 companies list sitagliptin as a human prescription drug in the openFDA NDC Directory, led by Zydus Lifesciences Limited, International Medication Systems, Ltd., Zydus Pharmaceuticals USA Inc., Apotex Inc., Teva Pharmaceutical Industries Ltd.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic JANUVIA?
- 3 companies list sitagliptin under an abbreviated new drug application (ANDA), the application type used for generics, and 5 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies sitagliptin active ingredient?
- 1 company lists sitagliptin as a bulk ingredient, including Optimus Drugs Private Limited.