Register entry
IPSEN MANUFACTURING IRELAND LIMITED
- Registered sites
- 2
- Drug products
- 17
- Live patents
- 133
- Countries
- 2
- Base
- Ireland
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingActive ingredient (API) manufactureLabellingFinished drug manufacturePackaging
Sites
Facilities
2| Site | Location | Operations | FEI |
|---|---|---|---|
| IPSEN PHARMA BIOTECH | SIGNESFrance | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3003749112 |
| IPSEN MANUFACTURING IRELAND LIMITED | BlanchardstownIreland | Analytical testing, Active ingredient (API) manufacture | 3002807392 |
Exclusivity
Patents
133Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| BYLVAY | ODEVIXIBAT | Nov 2031 |
| BYLVAY | ODEVIXIBAT | Mar 2034 |
| BYLVAY | ODEVIXIBAT | Jun 2039 |
| BYLVAY | ODEVIXIBAT | Nov 2041 |
| IQIRVO | ELAFIBRANOR | Mar 2037 |
| IQIRVO | ELAFIBRANOR | Mar 2044 |
| ONIVYDE | IRINOTECAN HYDROCHLORIDE | Jan 2027 |
| ONIVYDE | IRINOTECAN HYDROCHLORIDE | Aug 2028 |
| ONIVYDE | IRINOTECAN HYDROCHLORIDE | Jun 2033 |
| ONIVYDE | IRINOTECAN HYDROCHLORIDE | Aug 2036 |
| ONIVYDE | IRINOTECAN HYDROCHLORIDE | Oct 2036 |
| SOHONOS | PALOVAROTENE | Aug 2031 |
| SOHONOS | PALOVAROTENE | Jun 2037 |
Catalogue
Marketed products
17Showing 17 of 17.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| Bylvay | odevixibat | CAPSULE, COATED PELLETS | NDA |
| Bylvay | odevixibat | CAPSULE | NDA |
| Bylvay | odevixibat | CAPSULE, COATED PELLETS | NDA |
| Bylvay | odevixibat | CAPSULE | NDA |
| Dysport | Botulinum Toxin Type A | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| Dysport | Botulinum Toxin Type A | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| IQIRVO | elafibranor | TABLET, FILM COATED | NDA |
| Increlex | mecasermin | INJECTION, SOLUTION | BLA |
| Onivyde | IRINOTECAN HYDROCHLORIDE | INJECTION, POWDER, FOR SOLUTION | NDA |
| SOHONOS | palovarotene | CAPSULE | NDA |
| SOHONOS | palovarotene | CAPSULE | NDA |
| SOHONOS | palovarotene | CAPSULE | NDA |
| SOHONOS | palovarotene | CAPSULE | NDA |
| SOHONOS | palovarotene | CAPSULE | NDA |
| SOMATULINE DEPOT | lanreotide acetate | INJECTION | NDA |
| SOMATULINE DEPOT | lanreotide acetate | INJECTION | NDA |
| SOMATULINE DEPOT | lanreotide acetate | INJECTION | 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.