Generic competition · all medicines · read 12 November 2026
Is there a generic of Roflumilast, and who makes it?
Roflumilast appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 9 generic makers listed as marketed across them. 2 groups have a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. Where both are dated, the first generic approval came 7.4 years after the first brand approval. This is the Orange Book's listing, not a forecast.
Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.
- Roflumilast appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 9 generic makers listed as marketed across them.
- 2 groups have a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
- Where both are dated, the first generic approval came 7.4 years after the first brand approval.
- Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.
Tablet, Oral
Four or more generic makers listed
Brand listed as marketed: Daliresp. 9 generic makers with 17 generic products listed as marketed; the first generic approval is dated 13 July 2018.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Pharmazone | 3 October 2018 | 2 |
| Hetero Labs Ltd Unit Iii | 23 November 2018 | 2 |
| Micro Labs Ltd | 22 March 2019 | 2 |
| Strides Pharma Global Pte Ltd | 30 March 2020 | 2 |
| Zydus Pharmaceuticals Usa Inc | 10 February 2022 | 2 |
| Prinston Pharmaceutical Inc | 10 May 2022 | 1 |
| Msn Laboratories Private Ltd | 7 September 2022 | 2 |
| Aurobindo Pharma Ltd | 17 April 2023 | 2 |
| Alkem Laboratories Ltd | 18 April 2023 | 2 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Cream, Topical
Brand listed, no generic listed as marketed
Brand listed as marketed: Zoryve. No generic is listed as marketed.
Patents and exclusivities still listed
- 9 July 2027Exclusivity NS Zoryve
- 4 October 2028Exclusivity NS Zoryve
- 29 June 2029Exclusivity NPP Zoryve
- 7 June 2037Patent 12005051
- 7 June 2037Patent 11992480
- 7 June 2037Patent 11819496
- 7 June 2037Patent 12310956
- 7 June 2037Patent 9907788
- 7 June 2037Patent 12042487 drug product
- 7 June 2037Patent 12016848 drug product
- 7 June 2037Patent 12336983 drug product
10 more patents are listed.
Foam, Topical
Brand listed, no generic listed as marketed
Brand listed as marketed: Zoryve. No generic is listed as marketed.
Patents and exclusivities still listed
- 15 December 2026Exclusivity NP Zoryve
- 22 May 2028Exclusivity I-969 Zoryve
- 7 June 2037Patent 9907788
- 7 June 2037Patent 11819496
- 7 June 2037Patent 11992480
- 7 June 2037Patent 12005051
- 7 June 2037Patent 12310956
- 7 June 2037Patent 12011437 drug product
- 7 June 2037Patent 12016848 drug product
- 7 June 2037Patent 12005052 drug product
13 more patents are listed.
US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.
Where can you go from this result?
Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.