Drug
Who makes roflumilast?
18 companies list roflumilast as a human prescription drug, including under the names Daliresp, ZORYVE. Forms: aerosol, foam; cream; tablet. Routes: oral, topical.
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 roflumilast
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Arcutis Biotherapeutics, Inc. | aerosol, foam; cream | NDANDA215985, NDA217242 | 4 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet | ANDAANDA208256 | 3 | 0 |
| AstraZeneca PLCUnited States | tablet | NDANDA022522 | 2 | 15 |
| Zydus Lifesciences LimitedIndia | tablet | ANDAANDA208303 | 2 | 12 |
| Aurobindo Pharma LimitedIndia | tablet | ANDAANDA213298 | 2 | 6 |
| Micro Labs LimitedIndia | tablet | ANDAANDA208180 | 2 | 5 |
| Camber Pharmaceuticals, Inc.United States | tablet | ANDAANDA208213 | 2 | 1 |
| Zydus Pharmaceuticals USA Inc.India | tablet | ANDAANDA208303 | 2 | 1 |
| ASCEND Therapeutics US, LLC | tablet | ANDAANDA212490 | 2 | 0 |
| Amici Pharmaceuticals, LLC. | tablet | ANDAANDA208236 | 2 | 0 |
| AvKARE | tablet | ANDAANDA208247 | 2 | 0 |
| Jubilant Cadista Pharmaceuticals Inc. | tablet | ANDAANDA208236 | 2 | 0 |
| Novadoz Pharmaceuticals LLC | tablet | ANDAANDA208256 | 2 | 0 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA208213 | 1 | 5 |
| Strides Pharma Science LimitedIndia | tablet | ANDAANDA208247 | 1 | 5 |
| Bryant Ranch PrepackUnited States | tablet | ANDAANDA208180 | 1 | 1 |
| Golden State Medical Supply Inc.United States | tablet | ANDAANDA212490 | 1 | 1 |
| Solco healthcare U.S., LLC | tablet | ANDAANDA208299 | 1 | 0 |
Bulk ingredient listings
- Interquim, S.A.Spain · 3 NDC
- AX Pharmaceutical CorpCanada · 1 NDC
- Alivus Life Sciences Limited · 1 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- Hetero Drugs LimitedIndia · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- Mylan Pharmaceuticals, Inc. · 1 NDC
- SINTENOVO SA DE CVMexico · 1 NDC
- SciAnda (Changshu) Pharmaceuticals, Ltd.China · 1 NDC
- ScinoPharm Taiwan, Ltd.Taiwan · 1 NDC
- Viyash Life Sciences Private Limited · 1 NDC
- Zydus Lifesciences LimitedIndia · 1 NDC
Orange Book patents
20 unexpired patents list roflumilast as the active ingredient, expiring between Jun 2037 and Aug 2042. Application holder: ARCUTIS BIOTHERAPEUTICS INC.
Enquiry
Common questions
- Who makes roflumilast?
- 18 companies list roflumilast as a human prescription drug in the openFDA NDC Directory, led by Arcutis Biotherapeutics, Inc., MAJOR Pharmaceuticals Inc., AstraZeneca PLC, Zydus Lifesciences Limited, Aurobindo Pharma Limited. 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 Daliresp?
- 16 companies list roflumilast under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies roflumilast active ingredient?
- 12 companies list roflumilast as a bulk ingredient, including Interquim, S.A., AX Pharmaceutical Corp, Alivus Life Sciences Limited, Aurobindo Pharma Limited.