Register entry
Sarepta Therapeutics Inc
- Registered sites
- 1
- Drug products
- 65
- Live patents
- 16
- 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 testing
Sites
Facilities
1| Site | Location | Operations | FEI |
|---|---|---|---|
| Sarepta Therapeutics Inc | Andover, MAUnited States | Analytical testing | 3012807588 |
Exclusivity
Patents
16Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| AMONDYS 45 | CASIMERSEN | Feb 2029 |
| AMONDYS 45 | CASIMERSEN | Nov 2030 |
| EXONDYS 51 | ETEPLIRSEN | Oct 2028 |
| EXONDYS 51 | ETEPLIRSEN | Feb 2029 |
| EXONDYS 51 | ETEPLIRSEN | Mar 2034 |
| VYONDYS 53 | GOLODIRSEN | Jun 2028 |
Catalogue
Marketed products
65Showing 65 of 65.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| AMONDYS 45 | casimersen | INJECTION | NDA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | KIT | BLA |
| Exondys 51 | eteplirsen | INJECTION | NDA |
| Exondys 51 | eteplirsen | INJECTION | NDA |
| Vyondys 53 | golodirsen | INJECTION | NDA |
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.