Drug
Who makes dexlansoprazole?
9 companies list dexlansoprazole as a human prescription drug, including under the names Dexilant. Forms: capsule, delayed release; capsule, delayed release pellets. 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 dexlansoprazole
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Alembic Pharmaceuticals LimitedIndia | capsule, delayed release | ANDAANDA219115 | 4 | 7 |
| Bryant Ranch PrepackUnited States | capsule, delayed release | ANDAANDA202294, ANDA202666 | 4 | 1 |
| International Medication Systems, Ltd.United States | capsule, delayed release | ANDA, NDA AUTHORIZED GENERICANDA202294, ANDA202666, NDA022287 | 3 | 3 |
| Takeda Pharmaceuticals U.S.A., Inc.Germany | capsule, delayed release | NDANDA022287 | 2 | 7 |
| Par Health USA, LLCIndia | capsule, delayed release | ANDAANDA202294 | 2 | 5 |
| Golden State Medical Supply Inc.United States | capsule, delayed release | ANDAANDA202666 | 2 | 1 |
| Mylan Pharmaceuticals, Inc. | capsule, delayed release pellets | ANDAANDA205205 | 2 | 0 |
| Upsher-Smith Laboratories, Inc. | capsule, delayed release | ANDAANDA202666 | 2 | 0 |
| Aphena Pharma Solutions - Tennessee, LLC | capsule, delayed release | ANDAANDA202666 | 1 | 0 |
Bulk ingredient listings
- Metrochem API Private LimitedIndia · 3 NDC
- Dr. Reddy's Laboratories LimitedIndia · 2 NDC
- Hetero Drugs LimitedIndia · 2 NDC
- Amino Chemicals Ltd.Malta · 1 NDC
- Jubilant Biosys LimitedIndia · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- Optimus Drugs Private LimitedIndia · 1 NDC
- Piramal Healthcare (Canada) LimitedIndia · 1 NDC
Orange Book patents
9 unexpired patents list dexlansoprazole as the active ingredient, expiring between Sept 2026 and Mar 2032. Application holder: TAKEDA PHARMACEUTICALS USA INC.
Enquiry
Common questions
- Who makes dexlansoprazole?
- 9 companies list dexlansoprazole as a human prescription drug in the openFDA NDC Directory, led by Alembic Pharmaceuticals Limited, Bryant Ranch Prepack, International Medication Systems, Ltd., Takeda Pharmaceuticals U.S.A., Inc., Par Health USA, LLC. 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 Dexilant?
- 8 companies list dexlansoprazole under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies dexlansoprazole active ingredient?
- 8 companies list dexlansoprazole as a bulk ingredient, including Metrochem API Private Limited, Dr. Reddy's Laboratories Limited, Hetero Drugs Limited, Amino Chemicals Ltd..