Register entry
IPSEN MANUFACTURING IRELAND LIMITED
Data as of · How to read this entry
- Registered sites
- 2
- Active NDC listings
- 17
- Live patents
- 133
- Exclusivities
- 4
- Shortage listings
- 1
- Countries
- 2
- Base
- Ireland
Authorisation
Registered operations
Analytical testing2Active ingredient (API) manufacture1Labelling1Finished drug manufacture1Packaging1
Sites
Registered establishments
2| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| IPSEN PHARMA BIOTECH | PARC D'ACTIVITE DE SIGNES CHE DEPARTEMENTAL 402, SIGNES, PROVENCE ALPES COTE D'AZUR 83870, France (FRA) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3003749112502570286 |
| IPSEN MANUFACTURING IRELAND LIMITED | Blanchardstown Industrial Park, Blanchardstown, Dublin 15 D15 Y363, Ireland (IRL) | Analytical testing, Active ingredient (API) manufacture | 3002807392987808565 |
Alert
Drug shortage listings
1| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Palovarotene CapsuleMusculoskeletal | SOHONOS, Capsule, 2.5 mg (NDC 15054-0025-1) | To Be Discontinued | - | 31 Aug 202631 Aug 2026 |
Catalogue
Drug listings by form and route
1717 active NDC listings: 17 human prescription drug. By marketing category: NDA 14, BLA 3.
| Dosage form | NDCs |
|---|---|
| capsule | 7 |
| injection | 3 |
| capsule, coated pellets | 2 |
| injection, powder, lyophilized, for solution | 2 |
| injection, powder, for solution | 1 |
| injection, solution | 1 |
| tablet, film coated | 1 |
| Route | NDCs |
|---|---|
| oral | 10 |
| subcutaneous | 4 |
| intramuscular | 2 |
| intravenous | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| ipsen biopharmaceuticals, inc. | 17 |
Exclusivity
Patents and exclusivities
133| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 8329213 | ONIVYDEirinotecan hydrochloride | substance, product | Jan 2027 |
| 8147867 | ONIVYDEirinotecan hydrochloride | substance, product | Aug 2028 |
| 10292954 | SOHONOSpalovarotene | use | Aug 2031 |
| 12023312 | SOHONOSpalovarotene | use | Aug 2031 |
| 9314439 | SOHONOSpalovarotene | use | Aug 2031 |
| 9789074 | SOHONOSpalovarotene | use | Aug 2031 |
| 10011633 | BYLVAYodevixibat | use | Nov 2031 |
| 10093697 | BYLVAYodevixibat | use | Nov 2031 |
| 10487111 | BYLVAYodevixibat | use | Nov 2031 |
| 10981952 | BYLVAYodevixibat | use | Nov 2031 |
| 11732006 | BYLVAYodevixibat | use | Nov 2031 |
| 12187812 | BYLVAYodevixibat | use | Nov 2031 |
| 12545705 | BYLVAYodevixibat | use | Nov 2031 |
| 10980795 | ONIVYDEirinotecan hydrochloride | use | Jun 2033 |
| 11369597 | ONIVYDEirinotecan hydrochloride | use | Jun 2033 |
| 12364691 | ONIVYDEirinotecan hydrochloride | use | Jun 2033 |
| 9339497 | ONIVYDEirinotecan hydrochloride | use | Jun 2033 |
| 9364473 | ONIVYDEirinotecan hydrochloride | use | Jun 2033 |
| 9452162 | ONIVYDEirinotecan hydrochloride | use | Jun 2033 |
| 9492442 | ONIVYDEirinotecan hydrochloride | use | Jun 2033 |
| 9717724 | ONIVYDEirinotecan hydrochloride | use | Jun 2033 |
| 9694018 | BYLVAYodevixibat | use | Mar 2034 |
| 11344552 | ONIVYDEirinotecan hydrochloride | use | Aug 2036 |
| 10456360 | ONIVYDEirinotecan hydrochloride | product | Oct 2036 |
| 10993914 | ONIVYDEirinotecan hydrochloride | product | Oct 2036 |
| 12059497 | ONIVYDEirinotecan hydrochloride | product | Oct 2036 |
| 11185519 | IQIRVOelafibranor | use | Mar 2037 |
| 11331292 | IQIRVOelafibranor | use | Mar 2037 |
| 11850223 | IQIRVOelafibranor | use | Mar 2037 |
| 11857523 | IQIRVOelafibranor | use | Mar 2037 |
| 12233038 | IQIRVOelafibranor | use | Mar 2037 |
| 12295927 | IQIRVOelafibranor | use | Mar 2037 |
| 12295928 | IQIRVOelafibranor | use | Mar 2037 |
| 12310935 | IQIRVOelafibranor | use | Mar 2037 |
| 12589086 | IQIRVOelafibranor | use | Mar 2037 |
| 10864194 | SOHONOSpalovarotene | use | Jun 2037 |
| 11622959 | SOHONOSpalovarotene | use | Jun 2037 |
| 12138245 | SOHONOSpalovarotene | use | Jun 2037 |
| 12201614 | SOHONOSpalovarotene | use | Jun 2037 |
| 12458626 | SOHONOSpalovarotene | use | Jun 2037 |
| 10975046 | BYLVAYodevixibat | substance | Jun 2039 |
| 11365182 | BYLVAYodevixibat | use | Jun 2039 |
| 11801226 | BYLVAYodevixibat | product | Jun 2039 |
| 11802115 | BYLVAYodevixibat | product | Jun 2039 |
| 12091394 | BYLVAYodevixibat | substance | Jun 2039 |
| 12508234 | BYLVAYodevixibat | use | Jun 2039 |
| 11583539 | BYLVAYodevixibat | use | Nov 2041 |
| 12447156 | BYLVAYodevixibat | use | Nov 2041 |
| 12673035 | IQIRVOelafibranor | product | Mar 2044 |
| Product | Exclusivity | Until |
|---|---|---|
| BYLVAYODEVIXIBAT | ODE-436 Orphan drug | Jun 2030 |
| IQIRVOELAFIBRANOR | ODE-486 Orphan drug | Jun 2031 |
| ONIVYDEIRINOTECAN HYDROCHLORIDE | ODE-463 Orphan drug | Feb 2031 |
| SOHONOSPALOVAROTENE | ODE-439 Orphan drug | Aug 2030 |
Catalogue
Marketed products
17| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Bylvay | odevixibat | capsule, coated pellets, oral | 15054-3301NDA |
| Bylvay | odevixibat | capsule, oral | 15054-3302NDA |
| Bylvay | odevixibat | capsule, coated pellets, oral | 15054-3303NDA |
| Bylvay | odevixibat | capsule, oral | 15054-3304NDA |
| Dysport | Botulinum Toxin Type A | injection, powder, lyophilized, for solution, intramuscular | 15054-0500BLA |
| Dysport | Botulinum Toxin Type A | injection, powder, lyophilized, for solution, intramuscular | 15054-0530BLA |
| IQIRVO | elafibranor | tablet, film coated, oral | 15054-0080NDA |
| Increlex | mecasermin | injection, solution, subcutaneous | 15054-1040BLA |
| Onivyde | IRINOTECAN HYDROCHLORIDE | injection, powder, for solution, intravenous | 15054-0043NDA |
| SOHONOS | palovarotene | capsule, oral | 15054-0010NDA |
| SOHONOS | palovarotene | capsule, oral | 15054-0015NDA |
| SOHONOS | palovarotene | capsule, oral | 15054-0025NDA |
| SOHONOS | palovarotene | capsule, oral | 15054-0050NDA |
| SOHONOS | palovarotene | capsule, oral | 15054-0100NDA |
| SOMATULINE DEPOT | lanreotide acetate | injection, subcutaneous | 15054-1060NDA |
| SOMATULINE DEPOT | lanreotide acetate | injection, subcutaneous | 15054-1090NDA |
| SOMATULINE DEPOT | lanreotide acetate | injection, subcutaneous | 15054-1120NDA |
Neighbours
Registered in the same town
1- MALLINCKRODT PHARMACEUTICALS IRELAND LIMITEDBLANCHARDSTOWN, IRL
Compare
Comparable companies in Ireland
- SK BIOTEK2 sites · 10 NDC
- LIEBEL-FLARSHEIM COMPANY LLC.2 sites · 7 NDC
- Q1 Scientific Ltd2 sites · 0 NDC
- Amneal Ireland Limited1 site · 513 NDC
- Alexion Pharmaceuticals, Inc.3 sites · 10 NDC
- Jazz Pharmaceuticals Operations UK Limited3 sites · 9 NDC
- LEO Pharma A/S3 sites · 9 NDC
- Novo Nordisk Production Ireland Limited1 site · 5 NDC
- TOPCHEM PHARMACEUTICALS LIMITED1 site · 5 NDC
- Clarochem Ireland Limited1 site · 3 NDC
Enquiry
Common questions
- Is IPSEN MANUFACTURING IRELAND LIMITED FDA approved?
- IPSEN MANUFACTURING IRELAND LIMITED holds 2 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are IPSEN MANUFACTURING IRELAND LIMITED's drugs manufactured?
- At registered sites in France, Ireland. The FDA register lists SIGNES; Blanchardstown. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
- What drugs does IPSEN MANUFACTURING IRELAND LIMITED make?
- 17 products are listed under IPSEN MANUFACTURING IRELAND LIMITED in the openFDA NDC Directory, most often as capsule; injection; capsule, coated pellets. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.