Register entry
Jazz Pharmaceuticals Operations UK Limited
- Registered sites
- 3
- Drug products
- 9
- Live patents
- 58
- 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
3| Site | Location | Operations | FEI |
|---|---|---|---|
| Jazz Pharmaceuticals Operations UK Limited | SittingbourneUnited Kingdom | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3004137922 |
| Jazz Pharmaceuticals Ireland Limited | AthloneIreland | Analytical testing, Finished drug manufacture, Packaging | 3010319651 |
| Jazz Pharmaceuticals Ireland Limited | Dublin 4Ireland | Finished drug manufacture | 3012774443 |
Exclusivity
Patents
58Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| DEFITELIO | DEFIBROTIDE SODIUM | Jun 2032 |
| VYXEOS | CYTARABINE; DAUNORUBICIN | Jan 2027 |
| VYXEOS | CYTARABINE; DAUNORUBICIN | Jul 2027 |
| VYXEOS | CYTARABINE; DAUNORUBICIN | Sept 2027 |
| VYXEOS | CYTARABINE; DAUNORUBICIN | Mar 2028 |
| VYXEOS | CYTARABINE; DAUNORUBICIN | Apr 2029 |
| VYXEOS | CYTARABINE; DAUNORUBICIN | Oct 2029 |
| VYXEOS | CYTARABINE; DAUNORUBICIN | Oct 2032 |
| VYXEOS | CYTARABINE; DAUNORUBICIN | Apr 2033 |
| XYREM | SODIUM OXYBATE | Mar 2033 |
| XYREM | SODIUM OXYBATE | Sept 2033 |
| XYWAV | CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE | Jan 2033 |
| XYWAV | CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE | Mar 2033 |
| XYWAV | CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE | Sept 2033 |
| XYWAV | CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE | Sept 2037 |
| XYWAV | CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE | Feb 2041 |
| ZEPZELCA | LURBINECTEDIN | Dec 2029 |
| ZEPZELCA | LURBINECTEDIN | May 2040 |
Catalogue
Marketed products
9Showing 9 of 9.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| DEFITELIO | defibrotide sodium | INJECTION, SOLUTION | NDA |
| Epidiolex | cannabidiol | SOLUTION | NDA |
| MODEYSO | dordaviprone | CAPSULE | NDA |
| Rylaze | asparaginase erwinia chrysanthemi (recombinant)-rywn | INJECTION | BLA |
| VYXEOS | (daunorubicin and cytarabine) liposome | INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION | NDA |
| XYWAV | calcium, magnesium, potassium, and sodium oxybates | SOLUTION | NDA |
| Xyrem | sodium oxybate | SOLUTION | NDA |
| ZEPZELCA | Lurbinectedin | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| ZIIHERA | zanidatamab-hrii | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
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.