Register entry
- Registered sites
- 1
- Active NDC listings
- 65
- Live patents
- 16
- Exclusivities
- 2
- Countries
- 1
- Base
- United States
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Sarepta Therapeutics Inc | 100 Federal Street, Andover, Massachusetts (MA) 01810, United States (USA) | Analytical testing | 3012807588072827382 |
Catalogue
Drug listings by form and route
6565 active NDC listings: 65 human prescription drug. By marketing category: BLA 61, NDA 4.
| Dosage form | NDCs |
|---|---|
| kit | 61 |
| injection | 4 |
| Route | NDCs |
|---|---|
| intravenous | 65 |
| Labeller name on the listing | NDCs |
|---|---|
| sarepta therapeutics, inc. | 65 |
Exclusivity
Patents and exclusivities
16| Patent | Product | Covers | Expiry |
|---|---|---|---|
| RE47691 | VYONDYS 53golodirsen | product | Jun 2028 |
| RE48468 | EXONDYS 51eteplirsen | use | Oct 2028 |
| RE47769 | EXONDYS 51eteplirsen | product | Feb 2029 |
| RE48960 | AMONDYS 45casimersen | substance, product | Feb 2029 |
| 10287586 | AMONDYS 45casimersen | substance, product | Nov 2030 |
| 10781450 | AMONDYS 45casimersen | use | Nov 2030 |
| 9228187 | AMONDYS 45casimersen | substance, product | Nov 2030 |
| 9758783 | AMONDYS 45casimersen | use | Nov 2030 |
| 10337003 | EXONDYS 51eteplirsen | use | Mar 2034 |
| 10364431 | EXONDYS 51eteplirsen | use | Mar 2034 |
| 9506058 | EXONDYS 51eteplirsen | use | Mar 2034 |
| Product | Exclusivity | Until |
|---|---|---|
| AMONDYS 45CASIMERSEN | ODE-347 Orphan drug | Feb 2028 |
| VYONDYS 53GOLODIRSEN | ODE-280 Orphan drug | Dec 2026 |
Catalogue
Marketed products
65| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| AMONDYS 45 | casimersen | injection, intravenous | 60923-227NDA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-501BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-502BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-503BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-504BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-505BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-506BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-507BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-508BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-509BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-510BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-511BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-512BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-513BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-514BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-515BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-516BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-517BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-518BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-519BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-520BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-521BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-522BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-523BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-524BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-525BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-526BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-527BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-528BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-529BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-530BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-531BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-532BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-533BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-534BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-535BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-536BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-537BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-538BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-539BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-540BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-541BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-542BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-543BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-544BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-545BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-546BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-547BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-548BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-549BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-550BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-551BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-552BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-553BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-554BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-555BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-556BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-557BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-558BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-559BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-560BLA |
| ELEVIDYS | delandistrogene moxeparvovec-rokl | kit, intravenous | 60923-561BLA |
| Exondys 51 | eteplirsen | injection, intravenous | 60923-284NDA |
| Exondys 51 | eteplirsen | injection, intravenous | 60923-363NDA |
| Vyondys 53 | golodirsen | injection, intravenous | 60923-465NDA |
Neighbours
Registered in the same town
2Compare
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Enquiry
Common questions
- Is Sarepta Therapeutics Inc FDA approved?
- Sarepta Therapeutics Inc holds 1 FDA-registered establishment 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 Sarepta Therapeutics Inc's registered sites?
- The FDA register lists Andover, MA. Registered operations: analytical testing.
- What drugs does Sarepta Therapeutics Inc make?
- 65 products are listed under Sarepta Therapeutics Inc in the openFDA NDC Directory, most often as kit; injection. 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.