Register entry
- Registered sites
- 1
- Active NDC listings
- 12
- Labeller names
- 2
- Live patents
- 151
- Countries
- 1
- Base
- United States
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Supernus Pharmaceuticals Inc | 9715 Key West Ave, Rockville, Maryland (MD) 20850, United States (USA) | Analytical testing | 3005209462363066452 |
Catalogue
Drug listings by form and route
1212 active NDC listings: 12 human prescription drug. By marketing category: NDA 12.
| Dosage form | NDCs |
|---|---|
| capsule, extended release | 7 |
| tablet | 3 |
| capsule, coated pellets | 2 |
| Route | NDCs |
|---|---|
| oral | 12 |
| Labeller name on the listing | NDCs |
|---|---|
| supernus pharmaceuticals, inc. | 9 |
| supernus pharmaceuticals, inc | 3 |
Exclusivity
Patents and exclusivities
151| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 10220042 | OXTELLAR XRoxcarbazepine | use | Apr 2027 |
| 11166960 | OXTELLAR XRoxcarbazepine | product | Apr 2027 |
| 11896599 | OXTELLAR XRoxcarbazepine | product | Apr 2027 |
| 7722898 | OXTELLAR XRoxcarbazepine | product | Apr 2027 |
| 7910131 | OXTELLAR XRoxcarbazepine | use | Apr 2027 |
| 8617600 | OXTELLAR XRoxcarbazepine | product | Apr 2027 |
| 8821930 | OXTELLAR XRoxcarbazepine | product | Apr 2027 |
| 9119791 | OXTELLAR XRoxcarbazepine | use | Apr 2027 |
| 9351975 | OXTELLAR XRoxcarbazepine | product | Apr 2027 |
| 9370525 | OXTELLAR XRoxcarbazepine | product | Apr 2027 |
| 9855278 | OXTELLAR XRoxcarbazepine | product | Apr 2027 |
| 10314790 | TROKENDI XRtopiramate | product | Nov 2027 |
| 8298580 | TROKENDI XRtopiramate | product | Nov 2027 |
| 8663683 | TROKENDI XRtopiramate | product | Nov 2027 |
| 8877248 | TROKENDI XRtopiramate | product | Nov 2027 |
| 8889191 | TROKENDI XRtopiramate | use | Nov 2027 |
| 8992989 | TROKENDI XRtopiramate | product | Nov 2027 |
| 9549940 | TROKENDI XRtopiramate | product | Nov 2027 |
| 9555004 | TROKENDI XRtopiramate | product | Nov 2027 |
| 9622983 | TROKENDI XRtopiramate | product | Nov 2027 |
| 8389578 | GOCOVRI, OSMOLEX ERamantadine hydrochloride | use | Jan 2028 |
| 8298576 | TROKENDI XRtopiramate | product | Apr 2028 |
| 11324753 | QELBREEviloxazine hydrochloride | use | Sept 2029 |
| 11458143 | QELBREEviloxazine hydrochloride | use | Sept 2029 |
| 12121523 | QELBREEviloxazine hydrochloride | use | Sept 2029 |
| 8252331 | OSMOLEX ERamantadine hydrochloride | product | Mar 2030 |
| 11197835 | GOCOVRIamantadine hydrochloride | use | Dec 2030 |
| 8741343 | GOCOVRIamantadine hydrochloride | use | Dec 2030 |
| 9867791 | GOCOVRIamantadine hydrochloride | use | Dec 2030 |
| 9867792 | GOCOVRIamantadine hydrochloride | use | Dec 2030 |
| 9867793 | GOCOVRIamantadine hydrochloride | use | Dec 2030 |
| 9877933 | GOCOVRIamantadine hydrochloride | use | Dec 2030 |
| 9358204 | QELBREEviloxazine hydrochloride | product | Feb 2033 |
| 9603853 | QELBREEviloxazine hydrochloride | use | Feb 2033 |
| 10646456 | GOCOVRIamantadine hydrochloride | use | Jun 2034 |
| 11903908 | GOCOVRIamantadine hydrochloride | use | Jun 2034 |
| 10154971 | GOCOVRIamantadine hydrochloride | use | Dec 2034 |
| 9662338 | QELBREEviloxazine hydrochloride | product | Apr 2035 |
| 10213393 | OSMOLEX ERamantadine hydrochloride | use | Feb 2038 |
| 10213394 | OSMOLEX ERamantadine hydrochloride | use | Feb 2038 |
| 10500170 | OSMOLEX ERamantadine hydrochloride | use | Feb 2038 |
| 10500171 | OSMOLEX ERamantadine hydrochloride | use | Feb 2038 |
| 10500172 | OSMOLEX ERamantadine hydrochloride | use | Feb 2038 |
| 10512617 | OSMOLEX ERamantadine hydrochloride | use | Feb 2038 |
| 11890261 | OSMOLEX ERamantadine hydrochloride | use | Feb 2038 |
| 11065213 | GOCOVRIamantadine hydrochloride | product | Aug 2038 |
| 11077073 | GOCOVRIamantadine hydrochloride | use | Aug 2038 |
| 12233033 | GOCOVRIamantadine hydrochloride | use | Aug 2038 |
Catalogue
Marketed products
12| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| GOCOVRI | AMANTADINE | capsule, coated pellets, oral | 17772-085NDA |
| GOCOVRI | AMANTADINE | capsule, coated pellets, oral | 17772-170NDA |
| OXTELLAR XR | OXCARBAZEPINE | tablet, oral | 17772-121NDA |
| OXTELLAR XR | OXCARBAZEPINE | tablet, oral | 17772-122NDA |
| OXTELLAR XR | OXCARBAZEPINE | tablet, oral | 17772-123NDA |
| QELBREE | viloxazine hydrochloride | capsule, extended release, oral | 17772-131NDA |
| QELBREE | viloxazine hydrochloride | capsule, extended release, oral | 17772-132NDA |
| QELBREE | viloxazine hydrochloride | capsule, extended release, oral | 17772-133NDA |
| Trokendi XR | topiramate | capsule, extended release, oral | 17772-101NDA |
| Trokendi XR | topiramate | capsule, extended release, oral | 17772-102NDA |
| Trokendi XR | topiramate | capsule, extended release, oral | 17772-103NDA |
| Trokendi XR | topiramate | capsule, extended release, oral | 17772-104NDA |
Neighbours
Registered in the same town
4- Sigma-Aldrich CorporationRockville, MD
- Bora Pharmaceutical Laboratories Inc.Rockville, MD
- Samsung Biologics Co., Ltd.Rockville, MD
- Aurinia Pharma U.S., Inc.Rockville, MD
Compare
Comparable companies in United States
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- ANI Pharmaceuticals, Inc.1 site · 299 NDC
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 site · 273 NDC
- Lannett Company, LLC1 site · 190 NDC
- CHATTEM, INC.1 site · 153 NDC
- PAI Holdings, LLC1 site · 146 NDC
- Allegiant Health1 site · 113 NDC
- Healthcare Sales and Service, LLC1 site · 105 NDC
- Civica, Inc. dba CivicaRx1 site · 103 NDC
- Leading Pharma, LLC1 site · 82 NDC
Enquiry
Common questions
- Is Supernus Pharmaceuticals Inc FDA approved?
- Supernus Pharmaceuticals 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 Supernus Pharmaceuticals Inc's registered sites?
- The FDA register lists Rockville, MD. Registered operations: analytical testing.
- What drugs does Supernus Pharmaceuticals Inc make?
- 12 products are listed under Supernus Pharmaceuticals Inc in the openFDA NDC Directory, most often as capsule, extended release; tablet; capsule, coated pellets. 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.