Register entry
- Registered sites
- 2
- Active NDC listings
- 21
- Live patents
- 249
- Exclusivities
- 1
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Analytical testing1Finished drug manufacture2
Sites
Registered establishments
2| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Avadel CNS Pharmaceuticals, LLC.Registrant: Alkermes, Inc. | 16640 Chesterfield Grove Rd. Ste. 200, Chesterfield, Missouri (MO) 63005, United States (USA) | Finished drug manufacture | 3012841301117441358 |
| Alkermes, IncRegistrant: Alkermes, Inc. | 265 Olinger Circle, Wilmington, Ohio (OH) 45177-2484, United States (USA) | Analytical testing, Finished drug manufacture | 1000142940858582083 |
Catalogue
Drug listings by form and route
2121 active NDC listings: 12 human prescription drug, 9 drug for further processing. By marketing category: NDA 12, DRUG FOR FURTHER PROCESSING 9.
| Dosage form | NDCs |
|---|---|
| injection, suspension | 5 |
| injection, suspension, extended release | 5 |
| for suspension, extended release | 4 |
| tablet, film coated | 4 |
| kit | 3 |
| Route | NDCs |
|---|---|
| oral | 7 |
| intramuscular | 2 |
| Labeller name on the listing | NDCs |
|---|---|
| alkermes, inc. | 21 |
Exclusivity
Patents and exclusivities
249| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 7919499 | VIVITROLnaltrexone | use | Oct 2029 |
| 10112903 | ARISTADA, ARISTADA INITIO KITaripiprazole lauroxil | substance | Jun 2030 |
| 8796276 | ARISTADA, ARISTADA INITIO KITaripiprazole lauroxil | use | Jun 2030 |
| 8431576 | ARISTADA, ARISTADA INITIO KITaripiprazole lauroxil | substance | Oct 2030 |
| 10716785 | LYBALVIolanzapine; samidorphan l-malate | use | Aug 2031 |
| 11185541 | LYBALVIolanzapine; samidorphan l-malate | use | Aug 2031 |
| 11241425 | LYBALVIolanzapine; samidorphan l-malate | use | Aug 2031 |
| 11351166 | LYBALVIolanzapine; samidorphan l-malate | use | Aug 2031 |
| 11793805 | LYBALVIolanzapine; samidorphan l-malate | use | Aug 2031 |
| 12194035 | LYBALVIolanzapine; samidorphan l-malate | use | Aug 2031 |
| 9126977 | LYBALVIolanzapine; samidorphan l-malate | product | Aug 2031 |
| 9517235 | LYBALVIolanzapine; samidorphan l-malate | use | Aug 2031 |
| 9119848 | LYBALVIolanzapine; samidorphan l-malate | substance | Aug 2031 |
| 8778960 | LYBALVIolanzapine; samidorphan l-malate | use | Feb 2032 |
| 10226458 | ARISTADAaripiprazole lauroxil | use | Mar 2032 |
| 9034867 | ARISTADAaripiprazole lauroxil | product | Nov 2032 |
| 12629366 | ARISTADAaripiprazole lauroxil | product | Dec 2032 |
| 10300054 | LYBALVIolanzapine; samidorphan l-malate | product | May 2033 |
| 11097006 | ARISTADAaripiprazole lauroxil | product | Sept 2033 |
| 12311027 | ARISTADAaripiprazole lauroxil | product | Sept 2033 |
| 9193685 | ARISTADAaripiprazole lauroxil | product | Oct 2033 |
| 11969469 | ARISTADAaripiprazole lauroxil | product | Apr 2034 |
| 10238651 | ARISTADAaripiprazole lauroxil | use | Mar 2035 |
| 10813928 | ARISTADAaripiprazole lauroxil | use | Mar 2035 |
| 11406632 | ARISTADAaripiprazole lauroxil | use | Mar 2035 |
| 12653822 | ARISTADAaripiprazole lauroxil | use | Mar 2035 |
| 9452131 | ARISTADAaripiprazole lauroxil | use | Mar 2035 |
| 9526726 | ARISTADAaripiprazole lauroxil | product | Mar 2035 |
| 10688091 | ARISTADA INITIO KITaripiprazole lauroxil | product | Aug 2035 |
| 10849894 | ARISTADA INITIO KITaripiprazole lauroxil | use | Aug 2035 |
| 11154552 | ARISTADA INITIO KITaripiprazole lauroxil | product | Aug 2035 |
| 10016415 | ARISTADA INITIO KITaripiprazole lauroxil | product | Sept 2035 |
| 10272062 | LUMRYZsodium oxybate | product | Jul 2037 |
| 10736866 | LUMRYZsodium oxybate | product | Jul 2037 |
| 10952986 | LUMRYZsodium oxybate | use | Jul 2037 |
| 10973795 | LUMRYZsodium oxybate | product | Jul 2037 |
| 11000498 | LUMRYZsodium oxybate | product | Jul 2037 |
| 11052061 | LUMRYZsodium oxybate | product | Jul 2037 |
| 11065224 | LUMRYZsodium oxybate | product | Jul 2037 |
| 11400065 | LUMRYZsodium oxybate | use | Jul 2037 |
| 11504347 | LUMRYZsodium oxybate | product | Jul 2037 |
| 11602512 | LUMRYZsodium oxybate | use | Jul 2037 |
| 11602513 | LUMRYZsodium oxybate | use | Jul 2037 |
| 11766418 | LUMRYZsodium oxybate | product | Jul 2037 |
| 11826335 | LUMRYZsodium oxybate | use | Jul 2037 |
| 11839597 | LUMRYZsodium oxybate | product | Jul 2037 |
| 11896572 | LUMRYZsodium oxybate | product | Jul 2037 |
| 11986451 | LUMRYZsodium oxybate | use | Jul 2037 |
| 12097175 | LUMRYZsodium oxybate | product | Jul 2037 |
| 12097176 | LUMRYZsodium oxybate | use | Jul 2037 |
| 12109186 | LUMRYZsodium oxybate | product | Jul 2037 |
| 12115142 | LUMRYZsodium oxybate | product | Jul 2037 |
| 12115143 | LUMRYZsodium oxybate | product | Jul 2037 |
| 12115144 | LUMRYZsodium oxybate | product | Jul 2037 |
| 12115145 | LUMRYZsodium oxybate | product | Jul 2037 |
| 12128021 | LUMRYZsodium oxybate | use | Jul 2037 |
| 12138239 | LUMRYZsodium oxybate | product | Jul 2037 |
| 12144793 | LUMRYZsodium oxybate | product | Jul 2037 |
| 12303478 | LUMRYZsodium oxybate | use | Jul 2037 |
| 11273158 | ARISTADA, ARISTADA INITIO KITaripiprazole lauroxil | use | Apr 2039 |
| Product | Exclusivity | Until |
|---|---|---|
| LUMRYZSODIUM OXYBATE | ODE-494 Orphan drug | Oct 2031 |
Catalogue
Marketed products
21| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ARISTADA | aripiprazole lauroxil | injection, suspension, extended release, intramuscular | 65757-402NDA |
| ARISTADA | aripiprazole lauroxil | injection, suspension, extended release, intramuscular | 65757-403NDA |
| LYBALVI | olanzapine and samidorphan L-malate | tablet, film coated, oral | 65757-651NDA |
| LYBALVI | olanzapine and samidorphan L-malate | tablet, film coated, oral | 65757-652NDA |
| LYBALVI | olanzapine and samidorphan L-malate | tablet, film coated, oral | 65757-654NDA |
| Lumryz | sodium oxybate | for suspension, extended release, oral | 13551-001NDA |
| Lumryz | sodium oxybate | for suspension, extended release, oral | 13551-002NDA |
| Lumryz | sodium oxybate | for suspension, extended release, oral | 13551-003NDA |
| Lumryz | sodium oxybate | for suspension, extended release, oral | 13551-004NDA |
| Lumryz | sodium oxybate | kit | 13551-005NDA |
| VIVITROL | naltrexone | kit | 65757-300NDA |
| VIVITROL | naltrexone | kit | 65757-301NDA |
| - | aripiprazole lauroxil | injection, suspension, extended release | 65757-401DRUG FOR FURTHER PROCESSING |
| - | aripiprazole lauroxil | injection, suspension, extended release | 65757-404DRUG FOR FURTHER PROCESSING |
| - | aripiprazole lauroxil | injection, suspension, extended release | 65757-500DRUG FOR FURTHER PROCESSING |
| - | naltrexone | injection, suspension | 65757-360DRUG FOR FURTHER PROCESSING |
| - | olanzapine and samidorphan l-malate | tablet, film coated | 65757-653DRUG FOR FURTHER PROCESSING |
| - | risperidone | injection, suspension | 65757-725DRUG FOR FURTHER PROCESSING |
| - | risperidone | injection, suspension | 65757-726DRUG FOR FURTHER PROCESSING |
| - | risperidone | injection, suspension | 65757-727DRUG FOR FURTHER PROCESSING |
| - | risperidone | injection, suspension | 65757-728DRUG FOR FURTHER PROCESSING |
Neighbours
Registered in the same town
2- Pfizer IncChesterfield, MO
- Med Resources, Inc.Chesterfield, MO
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Enquiry
Common questions
- Is Alkermes, Inc. FDA approved?
- Alkermes, Inc. holds 2 FDA-registered establishments in the United States. 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 Alkermes, Inc.'s drugs manufactured?
- The FDA register lists Chesterfield, MO; Wilmington, OH. Registered operations: analytical testing, finished drug manufacture.
- What drugs does Alkermes, Inc. make?
- 21 products are listed under Alkermes, Inc. in the openFDA NDC Directory, most often as injection, suspension; injection, suspension, extended release; for suspension, extended release. 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.