Register entry
Jazz Pharmaceuticals Operations UK Limited
Data as of · How to read this entry
- Registered sites
- 3
- Active NDC listings
- 9
- Live patents
- 58
- Exclusivities
- 3
- Countries
- 2
- Base
- Ireland
Authorisation
Registered operations
Analytical testing2Active ingredient (API) manufacture1Labelling1Finished drug manufacture3Packaging2
Sites
Registered establishments
3| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Jazz Pharmaceuticals Operations UK Limited | Building 730 Kent Science Park, Sittingbourne, Kent ME9 8AG, United Kingdom (GBR) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3004137922237098954 |
| Jazz Pharmaceuticals Ireland Limited | Monksland, Athlone, N37AX84, Ireland (IRL) | Analytical testing, Finished drug manufacture, Packaging | 3010319651986019606 |
| Jazz Pharmaceuticals Ireland Limited | 5th Floor, Waterloo Exchange, Waterloo Road, Dublin 4, D04 E5W7, Ireland (IRL) | Finished drug manufacture | 3012774443896650210 |
Catalogue
Drug listings by form and route
99 active NDC listings: 9 human prescription drug. By marketing category: NDA 7, BLA 2.
| Dosage form | NDCs |
|---|---|
| solution | 3 |
| injection, powder, lyophilized, for solution | 2 |
| capsule | 1 |
| injection | 1 |
| injection, powder, lyophilized, for suspension | 1 |
| injection, solution | 1 |
| Route | NDCs |
|---|---|
| intravenous | 4 |
| oral | 4 |
| intramuscular | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| jazz pharmaceuticals, inc. | 9 |
Exclusivity
Patents and exclusivities
58| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 7850990 | VYXEOScytarabine; daunorubicin | product | Jan 2027 |
| 9271931 | VYXEOScytarabine; daunorubicin | product | Jan 2027 |
| 7850990*PED | VYXEOScytarabine; daunorubicin | use | Jul 2027 |
| 9271931*PED | VYXEOScytarabine; daunorubicin | use | Jul 2027 |
| 8022279 | VYXEOScytarabine; daunorubicin | product | Sept 2027 |
| 8022279*PED | VYXEOScytarabine; daunorubicin | use | Mar 2028 |
| 8092828 | VYXEOScytarabine; daunorubicin | use | Apr 2029 |
| 8092828*PED | VYXEOScytarabine; daunorubicin | use | Oct 2029 |
| 7763615 | ZEPZELCAlurbinectedin | substance, product | Dec 2029 |
| 11085043 | DEFITELIOdefibrotide sodium | product | Jun 2032 |
| 11236328 | DEFITELIOdefibrotide sodium | use | Jun 2032 |
| 11746348 | DEFITELIOdefibrotide sodium | product | Jun 2032 |
| 12529052 | DEFITELIOdefibrotide sodium | product | Jun 2032 |
| 12534722 | DEFITELIOdefibrotide sodium | product | Jun 2032 |
| 10028912 | VYXEOScytarabine; daunorubicin | product | Oct 2032 |
| 10166184 | VYXEOScytarabine; daunorubicin | product | Oct 2032 |
| 10835492 | VYXEOScytarabine; daunorubicin | use | Oct 2032 |
| 10195168 | XYWAVcalcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate | product | Jan 2033 |
| 10675258 | XYWAVcalcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate | use | Jan 2033 |
| 11554102 | XYWAVcalcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate | product | Jan 2033 |
| 8591922 | XYWAVcalcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate | product | Jan 2033 |
| 8901173 | XYWAVcalcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate | product | Jan 2033 |
| 9132107 | XYWAVcalcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate | product | Jan 2033 |
| 10213400 | XYREM, XYWAVcalcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate; sodium oxybate | use | Mar 2033 |
| 10864181 | XYREM, XYWAVcalcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate; sodium oxybate | use | Mar 2033 |
| 11253494 | XYREM, XYWAVcalcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate; sodium oxybate | use | Mar 2033 |
| 11986446 | XYREM, XYWAVcalcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate; sodium oxybate | use | Mar 2033 |
| 8772306 | XYREM, XYWAVcalcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate; sodium oxybate | use | Mar 2033 |
| 9050302 | XYREM, XYWAVcalcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate; sodium oxybate | use | Mar 2033 |
| 9486426 | XYREM, XYWAVcalcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate; sodium oxybate | use | Mar 2033 |
| 10028912*PED | VYXEOScytarabine; daunorubicin | use | Apr 2033 |
| 10166184*PED | VYXEOScytarabine; daunorubicin | use | Apr 2033 |
| 10835492*PED | VYXEOScytarabine; daunorubicin | use | Apr 2033 |
| 10213400*PED | XYREM, XYWAVcalcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate; sodium oxybate | use | Sept 2033 |
| 10864181*PED | XYREM, XYWAVcalcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate; sodium oxybate | use | Sept 2033 |
| 11253494*PED | XYREM, XYWAVcalcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate; sodium oxybate | use | Sept 2033 |
| 8772306*PED | XYREM, XYWAVcalcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate; sodium oxybate | use | Sept 2033 |
| 9050302*PED | XYREM, XYWAVcalcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate; sodium oxybate | use | Sept 2033 |
| 9486426*PED | XYREM, XYWAVcalcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate; sodium oxybate | use | Sept 2033 |
| 11426373 | XYWAVcalcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate | use | Sept 2037 |
| 12324806 | ZEPZELCAlurbinectedin | use | May 2040 |
| 12433890 | ZEPZELCAlurbinectedin | use | May 2040 |
| 12440490 | ZEPZELCAlurbinectedin | use | May 2040 |
| 12138233 | XYWAVcalcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate | use | Feb 2041 |
| 12582622 | XYWAVcalcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate | use | Feb 2041 |
| Product | Exclusivity | Until |
|---|---|---|
| VYXEOSCYTARABINE; DAUNORUBICIN | PED Paediatric | Sept 2028 |
| XYWAVCALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE | ODE-369 Orphan drug | Aug 2028 |
| ZEPZELCALURBINECTEDIN | I-977 New indication | Oct 2028 |
Catalogue
Marketed products
9| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| DEFITELIO | defibrotide sodium | injection, solution, intravenous | 68727-800NDA |
| Epidiolex | cannabidiol | solution, oral | 70127-100NDA |
| MODEYSO | dordaviprone | capsule, oral | 68727-250NDA |
| Rylaze | asparaginase erwinia chrysanthemi (recombinant)-rywn | injection, intramuscular | 68727-900BLA |
| VYXEOS | (daunorubicin and cytarabine) liposome | injection, powder, lyophilized, for suspension, intravenous | 68727-745NDA |
| XYWAV | calcium, magnesium, potassium, and sodium oxybates | solution, oral | 68727-150NDA |
| Xyrem | sodium oxybate | solution, oral | 68727-100NDA |
| ZEPZELCA | Lurbinectedin | injection, powder, lyophilized, for solution, intravenous | 68727-712NDA |
| ZIIHERA | zanidatamab-hrii | injection, powder, lyophilized, for solution, intravenous | 68727-950BLA |
Neighbours
Registered in the same town
4- Almac Pharma Services (Ireland) LimitedAthlone, IRL
- Alexion Pharmaceuticals, Inc.Athlone, IRL
- PPD Development, L.P.Athlone, IRL
- Novo Nordisk Production Ireland LimitedATHLONE, IRL
Compare
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- Eurofins BioPharma Product Testing India Private Limited4 sites · 0 NDC
- Q1 Scientific Ltd2 sites · 0 NDC
- Amneal Ireland Limited1 site · 513 NDC
- Novo Nordisk Production Ireland Limited1 site · 5 NDC
- TOPCHEM PHARMACEUTICALS LIMITED1 site · 5 NDC
Enquiry
Common questions
- Is Jazz Pharmaceuticals Operations UK Limited FDA approved?
- Jazz Pharmaceuticals Operations UK Limited holds 3 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 Jazz Pharmaceuticals Operations UK Limited's drugs manufactured?
- At registered sites in the United Kingdom, Ireland. The FDA register lists Sittingbourne; Athlone; Dublin 4. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
- What drugs does Jazz Pharmaceuticals Operations UK Limited make?
- 9 products are listed under Jazz Pharmaceuticals Operations UK Limited in the openFDA NDC Directory, most often as solution; injection, powder, lyophilized, for solution; capsule. 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.