Register entry
LEO Pharma A/S
- Registered sites
- 3
- Drug products
- 9
- Live patents
- 38
- Countries
- 3
- Base
- Ireland
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingLabellingFinished drug manufacturePackaging
Sites
Facilities
3| Site | Location | Operations | FEI |
|---|---|---|---|
| LEO Pharma A/S | BallerupDenmark | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3002807496 |
| LEO Laboratories Ltd. | DublinIreland | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3002807468 |
| Leo Pharma Manufacturing Italy SRL. | SegrateItaly | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3002808260 |
Exclusivity
Patents
38Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| ANZUPGO | DELGOCITINIB | Sept 2031 |
| ENSTILAR | BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE | Jun 2031 |
| ENSTILAR | BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE | Dec 2031 |
| FINACEA | AZELAIC ACID | Sept 2027 |
| FINACEA | AZELAIC ACID | Oct 2027 |
| FINACEA | AZELAIC ACID | Dec 2027 |
| FINACEA | AZELAIC ACID | Feb 2029 |
| PICATO | INGENOL MEBUTATE | Dec 2026 |
| PICATO | INGENOL MEBUTATE | Jul 2027 |
| PICATO | INGENOL MEBUTATE | May 2033 |
Catalogue
Marketed products
9Showing 9 of 9.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| Adbry | tralokinumab-ldrm | INJECTION, SOLUTION | BLA |
| Adbry | tralokinumab-ldrm | INJECTION, SOLUTION | BLA |
| Anzupgo | delgocitinib | CREAM | NDA |
| ENSTILAR | calcipotriene and betamethasone dipropionate | AEROSOL, FOAM | NDA |
| FINACEA FOAM | azelaic acid | AEROSOL, FOAM | NDA |
| SPEVIGO | spesolimab | INJECTION | BLA |
| SPEVIGO | spesolimab | INJECTION | BLA |
| SPEVIGO | spesolimab | INJECTION | BLA |
| TACLONEX | calcipotriene and betamethasone dipropionate | SUSPENSION | NDA |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.