Register entry
MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Data as of · How to read this entry
- Registered sites
- 1
- Active NDC listings
- 1
- Live patents
- 69
- Exclusivities
- 1
- Countries
- 1
- Base
- Ireland
Authorisation
Registered operations
Analytical testing1Active ingredient (API) manufacture1Finished drug manufacture1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED | COLLEGE BUSINESS & TECHNOLOGY PARK CRUISERATH ROAD, BLANCHARDSTOWN, D15 TX2V, Ireland (IRL) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3013428851985601361 |
Exclusivity
Patents and exclusivities
69| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 7976870 | XARTEMIS XRacetaminophen; oxycodone hydrochloride | use | Jun 2027 |
| 8372432 | XARTEMIS XRacetaminophen; oxycodone hydrochloride | product | Mar 2029 |
| 8394408 | XARTEMIS XRacetaminophen; oxycodone hydrochloride | product | Mar 2029 |
| 8668929 | XARTEMIS XRacetaminophen; oxycodone hydrochloride | use | Mar 2029 |
| 11931377 | INOMAXnitric oxide | substance, product | Jun 2029 |
| 8282966 | INOMAXnitric oxide | use | Jun 2029 |
| 8293284 | INOMAXnitric oxide | use | Jun 2029 |
| 8431163 | INOMAXnitric oxide | use | Jun 2029 |
| 8795741 | INOMAXnitric oxide | use | Jun 2029 |
| 8846112 | INOMAXnitric oxide | use | Jun 2029 |
| 8377453 | XARTEMIS XRacetaminophen; oxycodone hydrochloride | product | Nov 2029 |
| 11931377*PED | INOMAXnitric oxide | use | Dec 2029 |
| 8282966*PED | INOMAXnitric oxide | use | Dec 2029 |
| 8293284*PED | INOMAXnitric oxide | use | Dec 2029 |
| 8431163*PED | INOMAXnitric oxide | use | Dec 2029 |
| 8795741*PED | INOMAXnitric oxide | use | Dec 2029 |
| 8846112*PED | INOMAXnitric oxide | use | Dec 2029 |
| 8597681 | XARTEMIS XRacetaminophen; oxycodone hydrochloride | product | Dec 2030 |
| 8980319 | XARTEMIS XRacetaminophen; oxycodone hydrochloride | product | Dec 2030 |
| 8291904 | INOMAXnitric oxide | product | Jan 2031 |
| 8573209 | INOMAXnitric oxide | product | Jan 2031 |
| 8573210 | INOMAXnitric oxide | product | Jan 2031 |
| 8776794 | INOMAXnitric oxide | product | Jan 2031 |
| 8776795 | INOMAXnitric oxide | product | Jan 2031 |
| 9265911 | INOMAXnitric oxide | product | Jan 2031 |
| 9295802 | INOMAXnitric oxide | product | Jan 2031 |
| 9408993 | INOMAXnitric oxide | product | Jan 2031 |
| 8291904*PED | INOMAXnitric oxide | use | Jul 2031 |
| 8573209*PED | INOMAXnitric oxide | use | Jul 2031 |
| 8573210*PED | INOMAXnitric oxide | use | Jul 2031 |
| 8776794*PED | INOMAXnitric oxide | use | Jul 2031 |
| 8776795*PED | INOMAXnitric oxide | use | Jul 2031 |
| 9265911*PED | INOMAXnitric oxide | use | Jul 2031 |
| 9295802*PED | INOMAXnitric oxide | use | Jul 2031 |
| 9408993*PED | INOMAXnitric oxide | use | Jul 2031 |
| 8658631 | XARTEMIS XRacetaminophen; oxycodone hydrochloride | product | May 2032 |
| 8741885 | XARTEMIS XRacetaminophen; oxycodone hydrochloride | product | May 2032 |
| 8992975 | XARTEMIS XRacetaminophen; oxycodone hydrochloride | product | May 2032 |
| 9050335 | XARTEMIS XRacetaminophen; oxycodone hydrochloride | product | May 2032 |
| 9468636 | XARTEMIS XRacetaminophen; oxycodone hydrochloride | use | May 2032 |
| 9279794 | INOMAXnitric oxide | product | Feb 2035 |
| 9279794*PED | INOMAXnitric oxide | use | Aug 2035 |
| 9770570 | INOMAXnitric oxide | use | May 2036 |
| 9770570*PED | INOMAXnitric oxide | use | Nov 2036 |
| 10335452 | TERLIVAZterlipressin acetate | use | Apr 2037 |
| 11752199 | ACTHAR GEL, ACTHAR GEL (AUTOINJECTOR)corticotropin | use | Jul 2041 |
| Product | Exclusivity | Until |
|---|---|---|
| TERLIVAZTERLIPRESSIN ACETATE | ODE-406 Orphan drug | Sept 2029 |
Catalogue
Marketed products
1| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | Corticotropin | solution | 83236-100DRUG FOR FURTHER PROCESSING |
Neighbours
Registered in the same town
1- IPSEN MANUFACTURING IRELAND LIMITEDBlanchardstown, IRL
Compare
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- Amneal Ireland Limited1 site · 513 NDC
- Novo Nordisk Production Ireland Limited1 site · 5 NDC
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- Clarochem Ireland Limited1 site · 3 NDC
- Upjohn Manufacturing Ireland Unlimited Company1 site · 2 NDC
- Eirgen Pharma Ltd1 site · 0 NDC
- HELSINN BIREX PHARMACEUTICALS LIMITED1 site · 0 NDC
- NORTON (WATERFORD) LIMITED1 site · 0 NDC
- IPSEN MANUFACTURING IRELAND LIMITED2 sites · 17 NDC
- SK BIOTEK2 sites · 10 NDC
Enquiry
Common questions
- Is MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED FDA approved?
- MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED holds 1 FDA-registered establishment in Ireland. 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 MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED's drugs manufactured?
- The FDA register lists BLANCHARDSTOWN. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
- What drugs does MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED make?
- 1 product is listed under MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED in the openFDA NDC Directory, most often as solution. 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.