Register entry
Alkermes, Inc.
- Registered sites
- 1
- Drug products
- 16
- Live patents
- 136
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingFinished drug manufacture
Sites
Facilities
1| Site | Location | Operations | FEI |
|---|---|---|---|
| Alkermes, Inc | Wilmington, OHUnited States | Analytical testing, Finished drug manufacture | 1000142940 |
Exclusivity
Patents
136Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| ARISTADA | ARIPIPRAZOLE LAUROXIL | Jun 2030 |
| ARISTADA | ARIPIPRAZOLE LAUROXIL | Oct 2030 |
| ARISTADA | ARIPIPRAZOLE LAUROXIL | Mar 2032 |
| ARISTADA | ARIPIPRAZOLE LAUROXIL | Nov 2032 |
| ARISTADA | ARIPIPRAZOLE LAUROXIL | Dec 2032 |
| ARISTADA | ARIPIPRAZOLE LAUROXIL | Sept 2033 |
| ARISTADA | ARIPIPRAZOLE LAUROXIL | Oct 2033 |
| ARISTADA | ARIPIPRAZOLE LAUROXIL | Apr 2034 |
| ARISTADA | ARIPIPRAZOLE LAUROXIL | Mar 2035 |
| ARISTADA | ARIPIPRAZOLE LAUROXIL | Apr 2039 |
| ARISTADA INITIO KIT | ARIPIPRAZOLE LAUROXIL | Jun 2030 |
| ARISTADA INITIO KIT | ARIPIPRAZOLE LAUROXIL | Oct 2030 |
| ARISTADA INITIO KIT | ARIPIPRAZOLE LAUROXIL | Aug 2035 |
| ARISTADA INITIO KIT | ARIPIPRAZOLE LAUROXIL | Sept 2035 |
| ARISTADA INITIO KIT | ARIPIPRAZOLE LAUROXIL | Apr 2039 |
| LYBALVI | OLANZAPINE; SAMIDORPHAN L-MALATE | Aug 2031 |
| LYBALVI | OLANZAPINE; SAMIDORPHAN L-MALATE | Aug 2031 |
| LYBALVI | OLANZAPINE; SAMIDORPHAN L-MALATE | Feb 2032 |
| LYBALVI | OLANZAPINE; SAMIDORPHAN L-MALATE | May 2033 |
| LYBALVI | OLANZAPINE; SAMIDORPHAN L-MALATE | Nov 2041 |
| VIVITROL | NALTREXONE | Oct 2029 |
Catalogue
Marketed products
16Showing 16 of 16.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| ARISTADA | aripiprazole lauroxil | INJECTION, SUSPENSION, EXTENDED RELEASE | NDA |
| ARISTADA | aripiprazole lauroxil | INJECTION, SUSPENSION, EXTENDED RELEASE | NDA |
| ARISTADA INITIO | aripiprazole lauroxil | INJECTION, SUSPENSION, EXTENDED RELEASE | NDA |
| LYBALVI | olanzapine and samidorphan L-malate | TABLET, FILM COATED | NDA |
| LYBALVI | olanzapine and samidorphan L-malate | TABLET, FILM COATED | NDA |
| VIVITROL | naltrexone | KIT | NDA |
| VIVITROL | naltrexone | KIT | NDA |
| - | aripiprazole lauroxil | INJECTION, SUSPENSION, EXTENDED RELEASE | DRUG FOR FURTHER PROCESSING |
| - | aripiprazole lauroxil | INJECTION, SUSPENSION, EXTENDED RELEASE | DRUG FOR FURTHER PROCESSING |
| - | naltrexone | INJECTION, SUSPENSION | DRUG FOR FURTHER PROCESSING |
| - | olanzapine and samidorphan l-malate | TABLET, FILM COATED | DRUG FOR FURTHER PROCESSING |
| - | olanzapine and samidorphan l-malate | TABLET, FILM COATED | DRUG FOR FURTHER PROCESSING |
| - | risperidone | INJECTION, SUSPENSION | DRUG FOR FURTHER PROCESSING |
| - | risperidone | INJECTION, SUSPENSION | DRUG FOR FURTHER PROCESSING |
| - | risperidone | INJECTION, SUSPENSION | DRUG FOR FURTHER PROCESSING |
| - | risperidone | INJECTION, SUSPENSION | DRUG FOR FURTHER PROCESSING |
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.